Trial Outcomes & Findings for Effect of Exercise and Surgical Weight Loss on Polyneuropathy (NCT NCT03617185)
NCT ID: NCT03617185
Last Updated: 2025-10-29
Results Overview
Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the proximal thigh.
COMPLETED
NA
140 participants
Baseline, 3 months, 12 months and 24 months
2025-10-29
Participant Flow
Participants were recruited from Bariatric Surgery clinics in Ann Arbor and Detroit.
140 participants were randomized to one of the four arms. Prior to randomization, participants had a screening visit, pre-baseline visit, and baseline visit to confirm eligibility. If participants qualified for the study, they were randomized and moved on with the study.
Participant milestones
| Measure |
Bariatric Surgery/HIIT
High Intensity Interval Training (HIIT) Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Procedure/Surgery: Bariatric surgery Patients will undergo bariatric surgery as part of their routine care.
|
No Bariatric Surgery/HIIT
High Intensity Interval Training (HIIT) Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Procedure/Surgery: None
|
Bariatric Surgery/Routine Exercise
Routine Exercise Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Procedure/Surgery: Bariatric surgery Patients will undergo bariatric surgery as part of their routine care.
|
No Bariatric Surgery/Routine Exercise
Routine Exercise Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Procedure/Surgery: None
|
|---|---|---|---|---|
|
Baseline
STARTED
|
35
|
35
|
35
|
35
|
|
Baseline
COMPLETED
|
35
|
32
|
32
|
32
|
|
Baseline
NOT COMPLETED
|
0
|
3
|
3
|
3
|
|
3 Months
STARTED
|
35
|
32
|
32
|
32
|
|
3 Months
COMPLETED
|
29
|
28
|
32
|
29
|
|
3 Months
NOT COMPLETED
|
6
|
4
|
0
|
3
|
|
12 Months
STARTED
|
29
|
28
|
32
|
29
|
|
12 Months
COMPLETED
|
26
|
27
|
28
|
28
|
|
12 Months
NOT COMPLETED
|
3
|
1
|
4
|
1
|
|
24 Months
STARTED
|
26
|
27
|
28
|
28
|
|
24 Months
COMPLETED
|
26
|
27
|
28
|
28
|
|
24 Months
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Bariatric Surgery/HIIT
High Intensity Interval Training (HIIT) Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Procedure/Surgery: Bariatric surgery Patients will undergo bariatric surgery as part of their routine care.
|
No Bariatric Surgery/HIIT
High Intensity Interval Training (HIIT) Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Procedure/Surgery: None
|
Bariatric Surgery/Routine Exercise
Routine Exercise Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Procedure/Surgery: Bariatric surgery Patients will undergo bariatric surgery as part of their routine care.
|
No Bariatric Surgery/Routine Exercise
Routine Exercise Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Procedure/Surgery: None
|
|---|---|---|---|---|
|
Baseline
Lost to Follow-up
|
0
|
2
|
1
|
1
|
|
Baseline
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
|
Baseline
Driving Distance/Travel
|
0
|
0
|
2
|
0
|
|
Baseline
Family Obligations
|
0
|
0
|
0
|
1
|
|
3 Months
Lost to Follow-up
|
4
|
1
|
0
|
2
|
|
3 Months
Withdrawal by Subject
|
1
|
3
|
0
|
0
|
|
3 Months
Driving Distance/Travel
|
1
|
0
|
0
|
0
|
|
3 Months
Family Obligations
|
0
|
0
|
0
|
1
|
|
12 Months
Lost to Follow-up
|
3
|
1
|
3
|
0
|
|
12 Months
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
12 Months
Driving Distance/Travel
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Effect of Exercise and Surgical Weight Loss on Polyneuropathy
Baseline characteristics by cohort
| Measure |
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
|
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.54 years
STANDARD_DEVIATION 7.56 • n=5 Participants
|
49.66 years
STANDARD_DEVIATION 6.98 • n=7 Participants
|
49.91 years
STANDARD_DEVIATION 5.77 • n=5 Participants
|
51.14 years
STANDARD_DEVIATION 8.08 • n=4 Participants
|
50.31 years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Bi/Multi Racial Non-Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native-American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native-American/Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
19 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the proximal thigh.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
Baseline
|
11.9 fibers/mm
Standard Deviation 3.9
|
12.7 fibers/mm
Standard Deviation 4.4
|
9.8 fibers/mm
Standard Deviation 4.9
|
11 fibers/mm
Standard Deviation 4.6
|
|
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
3 Months
|
12.6 fibers/mm
Standard Deviation 3.9
|
14.3 fibers/mm
Standard Deviation 5
|
9.9 fibers/mm
Standard Deviation 4.2
|
10.6 fibers/mm
Standard Deviation 6
|
|
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
12 Months
|
11.5 fibers/mm
Standard Deviation 6.1
|
14.2 fibers/mm
Standard Deviation 6.2
|
9.2 fibers/mm
Standard Deviation 4.2
|
8.5 fibers/mm
Standard Deviation 4.4
|
|
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
24 Months
|
11.9 fibers/mm
Standard Deviation 6.0
|
13.5 fibers/mm
Standard Deviation 6.2
|
10.3 fibers/mm
Standard Deviation 4.3
|
9.3 fibers/mm
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Intraepidermal Nerve Fiber Density (IENFD) as assessed by 3mm skin biopsies at the distal leg.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg.
3 Months
|
7.3 fibers/mm
Standard Deviation 4.1
|
6.2 fibers/mm
Standard Deviation 4.1
|
6.3 fibers/mm
Standard Deviation 3.6
|
5.5 fibers/mm
Standard Deviation 3.8
|
|
Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg.
24 Months
|
6.9 fibers/mm
Standard Deviation 4.5
|
7.4 fibers/mm
Standard Deviation 4.4
|
6.4 fibers/mm
Standard Deviation 3.8
|
5.8 fibers/mm
Standard Deviation 4.1
|
|
Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg.
Baseline
|
6.3 fibers/mm
Standard Deviation 4
|
6.8 fibers/mm
Standard Deviation 4.3
|
7.3 fibers/mm
Standard Deviation 4.1
|
5.7 fibers/mm
Standard Deviation 3.8
|
|
Intraepidermal Nerve Fiber Density (IENFD) at Distal Leg.
12 Months
|
7.7 fibers/mm
Standard Deviation 5.2
|
8.7 fibers/mm
Standard Deviation 5.4
|
6.4 fibers/mm
Standard Deviation 3.6
|
6.4 fibers/mm
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Density are quantified by fibers/mm2, a higher number represents a higher density of fibers. Lower numbers indicate worse neuropathy.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Corneal Confocal Microscopy (CCM) - Fiber Density
Baseline-Corneal Nerve Fiber Density (fibers/mm2)
|
22.1 fibers/mm^2
Standard Deviation 6.8
|
19.5 fibers/mm^2
Standard Deviation 5.7
|
19.5 fibers/mm^2
Standard Deviation 6.2
|
22.4 fibers/mm^2
Standard Deviation 5.4
|
|
Corneal Confocal Microscopy (CCM) - Fiber Density
3 Months-Corneal Nerve Fiber Density (fibers/mm2)
|
20 fibers/mm^2
Standard Deviation 6.5
|
19.9 fibers/mm^2
Standard Deviation 4.9
|
19.3 fibers/mm^2
Standard Deviation 6.5
|
19.8 fibers/mm^2
Standard Deviation 6.3
|
|
Corneal Confocal Microscopy (CCM) - Fiber Density
12 Months-Corneal Nerve Fiber Density (fibers/mm2)
|
19.8 fibers/mm^2
Standard Deviation 9.4
|
20.7 fibers/mm^2
Standard Deviation 5.2
|
17.2 fibers/mm^2
Standard Deviation 6.3
|
18.8 fibers/mm^2
Standard Deviation 6.8
|
|
Corneal Confocal Microscopy (CCM) - Fiber Density
24 Months-Corneal Nerve Fiber Density (fibers/mm2)
|
20.5 fibers/mm^2
Standard Deviation 5.1
|
20.2 fibers/mm^2
Standard Deviation 3.9
|
19 fibers/mm^2
Standard Deviation 5.5
|
18.8 fibers/mm^2
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Branch Density are quantified by branches/mm2, a higher number represents a higher density of branches. Lower numbers indicate worse neuropathy.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Corneal Confocal Microscopy (CCM) - Branch Density
Baseline-Corneal Nerve Branch Density (branches/mm2)
|
56.4 branches/mm^2
Standard Deviation 30.7
|
57.1 branches/mm^2
Standard Deviation 24.6
|
53.6 branches/mm^2
Standard Deviation 31.9
|
54.7 branches/mm^2
Standard Deviation 25.3
|
|
Corneal Confocal Microscopy (CCM) - Branch Density
3 Months-Corneal Nerve Branch Density (branches/mm2)
|
62.2 branches/mm^2
Standard Deviation 32
|
72.6 branches/mm^2
Standard Deviation 34
|
62 branches/mm^2
Standard Deviation 31.3
|
63.9 branches/mm^2
Standard Deviation 37.2
|
|
Corneal Confocal Microscopy (CCM) - Branch Density
24 Months-Corneal Nerve Branch Density (branches/mm2)
|
124.7 branches/mm^2
Standard Deviation 54.3
|
129.8 branches/mm^2
Standard Deviation 39.7
|
116.6 branches/mm^2
Standard Deviation 49.1
|
127.1 branches/mm^2
Standard Deviation 55.9
|
|
Corneal Confocal Microscopy (CCM) - Branch Density
12 Months-Corneal Nerve Branch Density (branches/mm2)
|
126.6 branches/mm^2
Standard Deviation 68.6
|
137.4 branches/mm^2
Standard Deviation 55.
|
101.2 branches/mm^2
Standard Deviation 57.9
|
116.8 branches/mm^2
Standard Deviation 79
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Corneal Nerve Fiber Length are quantified by mm/mm2, a higher number represents a higher total length of fibers. Lower numbers indicate worse neuropathy .
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Corneal Confocal Microscopy (CCM) - Fiber Length
24 Months-Corneal Nerve Fiber Length (mm/mm2)
|
25.2 mm/mm2
Standard Deviation 6.8
|
25.3 mm/mm2
Standard Deviation 4.8
|
24 mm/mm2
Standard Deviation 6.9
|
25.2 mm/mm2
Standard Deviation 7.4
|
|
Corneal Confocal Microscopy (CCM) - Fiber Length
Baseline-Corneal Nerve Fiber Length (mm/mm2)
|
18.6 mm/mm2
Standard Deviation 6.1
|
18.9 mm/mm2
Standard Deviation 5.3
|
17.9 mm/mm2
Standard Deviation 6.1
|
19.3 mm/mm2
Standard Deviation 4.9
|
|
Corneal Confocal Microscopy (CCM) - Fiber Length
3 Months-Corneal Nerve Fiber Length (mm/mm2)
|
19 mm/mm2
Standard Deviation 5.9
|
20.6 mm/mm2
Standard Deviation 5.3
|
19.3 mm/mm2
Standard Deviation 5.5
|
19.3 mm/mm2
Standard Deviation 6.1
|
|
Corneal Confocal Microscopy (CCM) - Fiber Length
12 Months-Corneal Nerve Fiber Length (mm/mm2)
|
25.7 mm/mm2
Standard Deviation 7.5
|
28 mm/mm2
Standard Deviation 6.7
|
23 mm/mm2
Standard Deviation 8.1
|
24.7 mm/mm2
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Non-invasive imaging technique of the corneal nerves to quantify nerve density and morphology. Tortuosity Coefficient represents the total tortuosity (twisting/bending of nerves). As a coefficient the value is unitless, a higher value represents greater tortuosity. Lower numbers indicate worse neuropathy.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient
Baseline-Corneal Tortuosity (coefficient value)
|
19.4 Coefficient
Standard Deviation 5.6
|
19 Coefficient
Standard Deviation 6.3
|
18.6 Coefficient
Standard Deviation 6.7
|
19.2 Coefficient
Standard Deviation 4.9
|
|
Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient
3 Months-Corneal Tortuosity (coefficient value)
|
17.8 Coefficient
Standard Deviation 4.3
|
19.9 Coefficient
Standard Deviation 5.6
|
17.7 Coefficient
Standard Deviation 4.6
|
18.5 Coefficient
Standard Deviation 4.9
|
|
Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient
12 Months-Corneal Tortuosity (coefficient value)
|
20.8 Coefficient
Standard Deviation 7.2
|
20.6 Coefficient
Standard Deviation 5.6
|
20.1 Coefficient
Standard Deviation 7.3
|
21.4 Coefficient
Standard Deviation 5.8
|
|
Corneal Confocal Microscopy (CCM) - Tortuosity Coefficient
24 Months-Corneal Tortuosity (coefficient value)
|
20 Coefficient
Standard Deviation 10.1
|
22 Coefficient
Standard Deviation 7.8
|
21 Coefficient
Standard Deviation 4.9
|
20.1 Coefficient
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
24-2 FDT was used to evaluate retinopathy using visual field deficits. Mean Deviation is presented below. Mean deviation is the average difference from normal expected value in the patients' particular age group. Lower values indicate more visual deficit. Higher values indicate fewer visual deficit.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
24-2 Frequency Doubling Technology (FDT) - Mean Deviation
Baseline-Mean Deviation
|
-1.6 dB
Standard Deviation 4.2
|
-1.6 dB
Standard Deviation 2.7
|
-2 dB
Standard Deviation 4.1
|
-2.5 dB
Standard Deviation 4
|
|
24-2 Frequency Doubling Technology (FDT) - Mean Deviation
3 Months-Mean Deviation
|
-1 dB
Standard Deviation 4.1
|
-1.5 dB
Standard Deviation 2.7
|
-1.7 dB
Standard Deviation 4
|
-2.8 dB
Standard Deviation 4.6
|
|
24-2 Frequency Doubling Technology (FDT) - Mean Deviation
12 Months-Mean Deviation
|
-0.9 dB
Standard Deviation 3.2
|
-1.3 dB
Standard Deviation 3.1
|
-2.4 dB
Standard Deviation 3.8
|
-1.5 dB
Standard Deviation 4.3
|
|
24-2 Frequency Doubling Technology (FDT) - Mean Deviation
24 Months-Mean Deviation
|
-1.1 dB
Standard Deviation 3.8
|
-0.7 dB
Standard Deviation 2.7
|
-2.3 dB
Standard Deviation 3.4
|
-2.1 dB
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
24-2 FDT was used to evaluate retinopathy using visual field deficits. Foveal sensitivity is presented below. Foveal sensitivity is the measurement of the fovea's light detection ability. Lower values suggest visual field deficits.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB
Baseline-Foveal Sensitivity
|
27.7 dB
Standard Deviation 4.5
|
28.3 dB
Standard Deviation 3.5
|
26.9 dB
Standard Deviation 4.9
|
25.4 dB
Standard Deviation 5.9
|
|
24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB
3 Months--Foveal Sensitivity
|
28.3 dB
Standard Deviation 5.3
|
28.3 dB
Standard Deviation 4.5
|
27.1 dB
Standard Deviation 4.1
|
26.4 dB
Standard Deviation 4.6
|
|
24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB
12 Months--Foveal Sensitivity
|
28.1 dB
Standard Deviation 4
|
28.9 dB
Standard Deviation 3.6
|
25.9 dB
Standard Deviation 5.5
|
28.3 dB
Standard Deviation 4.6
|
|
24-2 Frequency Doubling Technology (FDT) - Foveal Sensitivity dB
24 Months--Foveal Sensitivity
|
27 dB
Standard Deviation 5.3
|
28.2 dB
Standard Deviation 4.5
|
26.7 dB
Standard Deviation 5
|
26.5 dB
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
24-2 FDT was used to evaluate retinopathy using visual field deficits. Pattern SD (PSD) is presented below. PSD provides information about localized loss. A higher PSD indicates a non-uniform sensitivity loss and visual field deficit.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
24-2 Frequency Doubling Technology (FDT) - Pattern SD
Baseline-Patter SD
|
3.4 dB
Standard Deviation 1.1
|
3.1 dB
Standard Deviation 1.1
|
3.3 dB
Standard Deviation 1.1
|
3.7 dB
Standard Deviation 1.3
|
|
24-2 Frequency Doubling Technology (FDT) - Pattern SD
3 Months-Patter SD
|
3.1 dB
Standard Deviation 1.1
|
3.2 dB
Standard Deviation 1.3
|
3.3 dB
Standard Deviation 1
|
3.9 dB
Standard Deviation 1.7
|
|
24-2 Frequency Doubling Technology (FDT) - Pattern SD
12 Months-Patter SD
|
3.2 dB
Standard Deviation 1.1
|
3.3 dB
Standard Deviation 1.7
|
3.5 dB
Standard Deviation 1.1
|
3.6 dB
Standard Deviation 1.6
|
|
24-2 Frequency Doubling Technology (FDT) - Pattern SD
24 Months-Patter SD
|
3.2 dB
Standard Deviation 0.8
|
3.1 dB
Standard Deviation 0.7
|
3.5 dB
Standard Deviation 1.1
|
3.9 dB
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
As assessed by fundus photographs, participants were identified as either having retinopathy or not having retinopathy. Data is shown as number of people with retinopathy at a particular study visit.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Retinal Fundus Photography
Baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Retinal Fundus Photography
3 Months
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Retinal Fundus Photography
12 Months
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Retinal Fundus Photography
24 Months
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Latency measures the time in millisecond between stimulation and the recording electrode. Was performed on sural, peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \>6.5 - Abnormal * Sural: 0 - No response, \>4.5 - Abnormal * Tibial: 0 - No response, \>6.1 - Abnormal
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Nerve Conduction Study (NCS) - Latency
Baseline-Peroneal distal motor latency (ms)
|
4.6 ms
Standard Deviation 0.8
|
4.4 ms
Standard Deviation 0.6
|
4.4 ms
Standard Deviation 0.7
|
4.5 ms
Standard Deviation 1
|
|
Nerve Conduction Study (NCS) - Latency
Baseline-Sural peak latency (ms)
|
3.8 ms
Standard Deviation 0.5
|
3.7 ms
Standard Deviation 0.4
|
3.6 ms
Standard Deviation 0.3
|
3.9 ms
Standard Deviation 0.4
|
|
Nerve Conduction Study (NCS) - Latency
Baseline-Tibial distal motor latency (ms)
|
4.8 ms
Standard Deviation 0.6
|
4.9 ms
Standard Deviation 0.8
|
4.5 ms
Standard Deviation 0.6
|
4.7 ms
Standard Deviation 0.7
|
|
Nerve Conduction Study (NCS) - Latency
24 Months-Peroneal distal motor latency (ms)
|
4.3 ms
Standard Deviation 0.5
|
4.4 ms
Standard Deviation 0.7
|
4.2 ms
Standard Deviation 0.7
|
4.2 ms
Standard Deviation 0.7
|
|
Nerve Conduction Study (NCS) - Latency
24 Months-Sural peak latency (ms)
|
3.5 ms
Standard Deviation 0.4
|
3.5 ms
Standard Deviation 0.4
|
3.6 ms
Standard Deviation 0.6
|
3.4 ms
Standard Deviation 0.5
|
|
Nerve Conduction Study (NCS) - Latency
24 Months-Tibial distal motor latency (ms)
|
4.3 ms
Standard Deviation 0.7
|
4.4 ms
Standard Deviation 0.8
|
4.3 ms
Standard Deviation 0.9
|
4.6 ms
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Amplitude measures the height of electrical signal (waveform) in millivolts produced by the stimulated motor nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \< 1.1 - Abnormal * Tibial: 0 - No response, \<1.1 - Abnormal
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Nerve Conduction Study (NCS) - Motor Amplitude
Baseline-Peroneal amplitude (mV)
|
5.21 mV
Standard Deviation 2.39
|
5.95 mV
Standard Deviation 3.05
|
5.18 mV
Standard Deviation 2.56
|
6.25 mV
Standard Deviation 4.13
|
|
Nerve Conduction Study (NCS) - Motor Amplitude
Baseline-Tibial amplitude (mV)
|
9.4 mV
Standard Deviation 3.59
|
9.16 mV
Standard Deviation 4.55
|
8.06 mV
Standard Deviation 4.4
|
7.59 mV
Standard Deviation 4.66
|
|
Nerve Conduction Study (NCS) - Motor Amplitude
24 Months-Peroneal amplitude (mV)
|
4.9 mV
Standard Deviation 2.11
|
6.23 mV
Standard Deviation 2.93
|
4.93 mV
Standard Deviation 2.02
|
5.11 mV
Standard Deviation 4.04
|
|
Nerve Conduction Study (NCS) - Motor Amplitude
24 Months-Tibial amplitude (mV)
|
9.65 mV
Standard Deviation 4.98
|
9.28 mV
Standard Deviation 4.75
|
8.54 mV
Standard Deviation 4.02
|
8.04 mV
Standard Deviation 4.22
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Amplitude measures the height of electrical signal (waveform) in microvolts produced by the stimulated sensory nerve. Was performed on sural nerve. No response and abnormal values indicate neuropathy. \* Sural: 0 - No response, \<4 - Abnormal
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Nerve Conduction Study (NCS) - Sensory Amplitude
Baseline-Sural amplitude (µV)
|
12.4 μV
Standard Deviation 5
|
10.8 μV
Standard Deviation 5.3
|
10.6 μV
Standard Deviation 4.7
|
9.1 μV
Standard Deviation 5.3
|
|
Nerve Conduction Study (NCS) - Sensory Amplitude
24 Months-Sural amplitude (µV)
|
12.4 μV
Standard Deviation 6.1
|
14.2 μV
Standard Deviation 5.8
|
10.7 μV
Standard Deviation 5.7
|
10.6 μV
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Conduction velocity (V) measures the speed (m/s) at which the electrical impulse travels along the nerve. Was performed on peroneal nerves. No response and abnormal values indicate neuropathy. Abnormal values are \<36 or 39, depending on whether certain criteria applied to the participant. Data was not analyzed separately.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Nerve Conduction Study (NCS) - CV
Baseline-Peroneal CV (m/s)
|
46.91 m/s
Standard Deviation 4.14
|
45.37 m/s
Standard Deviation 4.27
|
46.49 m/s
Standard Deviation 4.39
|
45.47 m/s
Standard Deviation 6.38
|
|
Nerve Conduction Study (NCS) - CV
24 Months-Peroneal CV (m/s)
|
46.96 m/s
Standard Deviation 5.58
|
47.48 m/s
Standard Deviation 4.25
|
44.69 m/s
Standard Deviation 5.43
|
45.96 m/s
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
F wave index measures the time in millisecond between stimulation at a distal (near the muscle) point and for the stimulus to travel to the spinal cord and back, allowing to assess the entire length of the nerve. Was performed on peroneal, and tibial nerves. No response and abnormal values indicate neuropathy. * Peroneal: 0 - No response, \>55 - Abnormal * Tibial: 0 - No response, \>55 - Abnormal
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Nerve Conduction Study (NCS) - F Wave Index
Baseline-Peroneal F wave index (ms)
|
48.29 ms
Standard Deviation 6.99
|
49.57 ms
Standard Deviation 4.54
|
49.28 ms
Standard Deviation 5.73
|
48.91 ms
Standard Deviation 9.35
|
|
Nerve Conduction Study (NCS) - F Wave Index
Baseline-Tibial F wave index (ms)
|
50.84 ms
Standard Deviation 8.88
|
51.92 ms
Standard Deviation 5.78
|
52.45 ms
Standard Deviation 5.4
|
50.8 ms
Standard Deviation 9.21
|
|
Nerve Conduction Study (NCS) - F Wave Index
24 Months-Peroneal F wave index (ms)
|
48.45 ms
Standard Deviation 4.57
|
48.5 ms
Standard Deviation 5.4
|
48.95 ms
Standard Deviation 5.18
|
50.07 ms
Standard Deviation 6.95
|
|
Nerve Conduction Study (NCS) - F Wave Index
24 Months-Tibial F wave index (ms)
|
50.56 ms
Standard Deviation 5.7
|
50.41 ms
Standard Deviation 6.06
|
50.61 ms
Standard Deviation 5.32
|
51.88 ms
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Deep breathing/exhalation to inhalation (E:I) ratio were evaluated using PS monitor software. Values \< 1 are abnormal, indicative of cardiovascular autonomic neuropathy
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio
Baseline
|
1.3 ratio
Standard Deviation 0.1
|
1.2 ratio
Standard Deviation 0.2
|
1.3 ratio
Standard Deviation 0.2
|
1.2 ratio
Standard Deviation 0.2
|
|
Cardiac Autonomic Neuropathy Testing-Deep Breathing/Exhalation to Inhalation (E:I) Ratio
24 Months
|
1.2 ratio
Standard Deviation 0.2
|
1.3 ratio
Standard Deviation 0.2
|
1.3 ratio
Standard Deviation 0.2
|
1.2 ratio
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Postural change-30:15 ratio was evaluated using PS monitor software. Values \< 1 are abnormal, indicative of cardiovascular autonomic neuropathy
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Cardiac Autonomic Neuropathy Testing (30:15 Ratio)
Baseline
|
1.1 ratio
Standard Deviation 0.2
|
1.1 ratio
Standard Deviation 0
|
1.1 ratio
Standard Deviation 0.1
|
1.1 ratio
Standard Deviation 0.1
|
|
Cardiac Autonomic Neuropathy Testing (30:15 Ratio)
24 Months
|
1.2 ratio
Standard Deviation 0.2
|
1.2 ratio
Standard Deviation 0.2
|
1.2 ratio
Standard Deviation 0.2
|
1.3 ratio
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Valsalva ratio was evaluated using PS monitor software. Values \<= 1.10 are abnormal, indicative of cardiovascular autonomic neuropathy
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Cardiac Autonomic Neuropathy Testing (Valsalva Ratio)
Baseline
|
1.5 ratio
Standard Deviation 0.2
|
1.5 ratio
Standard Deviation 0.2
|
1.4 ratio
Standard Deviation 0.2
|
1.4 ratio
Standard Deviation 0.2
|
|
Cardiac Autonomic Neuropathy Testing (Valsalva Ratio)
24 Months
|
1.3 ratio
Standard Deviation 0.2
|
1.4 ratio
Standard Deviation 0.3
|
1.3 ratio
Standard Deviation 0.2
|
1.4 ratio
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Toronto definition of probable neuropathy is having at least 2 out of 3 of the following: abnormal sensory examination, reflexes, and patient-reported symptoms. Data is reported as number of participants who, under the Toronto definition, were identified as having probable polyneuropathy.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy
Baseline
|
6 participants with probable neuropathy
|
5 participants with probable neuropathy
|
9 participants with probable neuropathy
|
11 participants with probable neuropathy
|
|
Participants With Probable Polyneuropathy as Defined by the Toronto Definition of Probable Neuropathy
24 Months
|
9 participants with probable neuropathy
|
7 participants with probable neuropathy
|
7 participants with probable neuropathy
|
9 participants with probable neuropathy
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
MNSI questionnaire is scored from 0-15, score \> 4 indicate neuropathy, higher scores indicate worse neuropathy. A score of 1 point is given for answers of "yes" for questions 1-6, 8-12, 14, and 15 and "no" for questions 7 and 13.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Michigan Neuropathy Screening Instrument (MNSI)
Baseline Questionnaire
|
2.5 score on a scale
Standard Deviation 2.4
|
2.5 score on a scale
Standard Deviation 1.7
|
2.4 score on a scale
Standard Deviation 2.2
|
2.8 score on a scale
Standard Deviation 2.1
|
|
Michigan Neuropathy Screening Instrument (MNSI)
3 Months Questionnaire
|
2.5 score on a scale
Standard Deviation 2.7
|
2 score on a scale
Standard Deviation 1.9
|
2.5 score on a scale
Standard Deviation 2.7
|
2.3 score on a scale
Standard Deviation 2.2
|
|
Michigan Neuropathy Screening Instrument (MNSI)
12 Months Questionnaire
|
2.7 score on a scale
Standard Deviation 2.9
|
2.1 score on a scale
Standard Deviation 2.2
|
2.3 score on a scale
Standard Deviation 2
|
2.8 score on a scale
Standard Deviation 2.1
|
|
Michigan Neuropathy Screening Instrument (MNSI)
24 Months Questionnaire
|
3.2 score on a scale
Standard Deviation 2.6
|
2.3 score on a scale
Standard Deviation 2
|
1.8 score on a scale
Standard Deviation 1.7
|
2.8 score on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
MNSI exam is scored from 0-8, score \>= 2.5 indicate neuropathy. Higher scores indicate worse neuropathy.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Michigan Neuropathy Screening Instrument (MNSI) - Exam
Baseline Exam
|
1 score on a scale
Standard Deviation 1.4
|
0.9 score on a scale
Standard Deviation 1.2
|
1.1 score on a scale
Standard Deviation 1.4
|
1.3 score on a scale
Standard Deviation 1.7
|
|
Michigan Neuropathy Screening Instrument (MNSI) - Exam
3 Months Exam
|
1 score on a scale
Standard Deviation 1.4
|
0.4 score on a scale
Standard Deviation 0.7
|
1.2 score on a scale
Standard Deviation 1.8
|
1.5 score on a scale
Standard Deviation 1.6
|
|
Michigan Neuropathy Screening Instrument (MNSI) - Exam
12 Months Exam
|
1.1 score on a scale
Standard Deviation 1.3
|
1 score on a scale
Standard Deviation 1.3
|
1.1 score on a scale
Standard Deviation 1.7
|
1.4 score on a scale
Standard Deviation 1.7
|
|
Michigan Neuropathy Screening Instrument (MNSI) - Exam
24 Months Exam
|
0.9 score on a scale
Standard Deviation 1.3
|
0.6 score on a scale
Standard Deviation 0.9
|
1.3 score on a scale
Standard Deviation 1.8
|
1.8 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
The Michigan Neuropathy Screening Instrument (MNSI) index is a weighted composite score computed using the sum of the b-coefficients for all items within the MNSI questionnaire (15 questions) and MNSI exam (4 physical/visual exam). Range: -0.93, 7.39 Values \> 2.5407 are indicative of clinical neuropathy
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Michigan Neuropathy Screening Instrument (MNSI) - Index
24 Months Index
|
1.7 MNSI Score
Standard Deviation 1.5
|
1.5 MNSI Score
Standard Deviation 1.5
|
1.9 MNSI Score
Standard Deviation 1.3
|
1.9 MNSI Score
Standard Deviation 1.2
|
|
Michigan Neuropathy Screening Instrument (MNSI) - Index
Baseline Index
|
1.6 MNSI Score
Standard Deviation 1.3
|
1.5 MNSI Score
Standard Deviation 0.9
|
1.4 MNSI Score
Standard Deviation 1.3
|
1.8 MNSI Score
Standard Deviation 1.3
|
|
Michigan Neuropathy Screening Instrument (MNSI) - Index
3 Months Index
|
1.6 MNSI Score
Standard Deviation 1.3
|
1.1 MNSI Score
Standard Deviation 1
|
1.7 MNSI Score
Standard Deviation 1.4
|
1.8 MNSI Score
Standard Deviation 1.5
|
|
Michigan Neuropathy Screening Instrument (MNSI) - Index
12 Months Index
|
1.7 MNSI Score
Standard Deviation 1.6
|
1.3 MNSI Score
Standard Deviation 1.1
|
1.6 MNSI Score
Standard Deviation 1.3
|
2 MNSI Score
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
UENS is a composite score with five sections measuring multiple clinical measures of nerve injury. Sections are scored separately for each side (Right vs Left), and the total score is the sum across everything. Range: 0-42, higher score represents more severe polyneuropathy.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Utah Early Neuropathy Score (UENS)
Baseline UENS Total Score
|
2.4 score on a scale
Standard Deviation 4.1
|
1.6 score on a scale
Standard Deviation 2.6
|
2.4 score on a scale
Standard Deviation 3.7
|
3.5 score on a scale
Standard Deviation 4.6
|
|
Utah Early Neuropathy Score (UENS)
3 Months UENS Total Score
|
1.7 score on a scale
Standard Deviation 2.8
|
1.8 score on a scale
Standard Deviation 3.5
|
2.9 score on a scale
Standard Deviation 5.2
|
3 score on a scale
Standard Deviation 4.3
|
|
Utah Early Neuropathy Score (UENS)
12 Months UENS Total Score
|
3.9 score on a scale
Standard Deviation 4.9
|
2.8 score on a scale
Standard Deviation 3.8
|
3.2 score on a scale
Standard Deviation 5.2
|
4.8 score on a scale
Standard Deviation 6.3
|
|
Utah Early Neuropathy Score (UENS)
24 Months UENS Total Score
|
2.8 score on a scale
Standard Deviation 3.7
|
2.5 score on a scale
Standard Deviation 3.6
|
2.9 score on a scale
Standard Deviation 2.3
|
3.8 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
mTNS is a scale of 0-33 that measures neuropathy symptoms and exam findings. Higher scores indicate more severe polyneuropathy.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Modified Toronto Neuropathy Score (mTNS)
Baseline
|
3.8 score on a scale
Standard Deviation 7.7
|
1.5 score on a scale
Standard Deviation 2.6
|
2.1 score on a scale
Standard Deviation 3.4
|
3.5 score on a scale
Standard Deviation 5.7
|
|
Modified Toronto Neuropathy Score (mTNS)
3 Months
|
2.1 score on a scale
Standard Deviation 4.2
|
1.3 score on a scale
Standard Deviation 1.5
|
2.1 score on a scale
Standard Deviation 4.4
|
2.8 score on a scale
Standard Deviation 4.7
|
|
Modified Toronto Neuropathy Score (mTNS)
12 Months
|
3.5 score on a scale
Standard Deviation 5.9
|
1.8 score on a scale
Standard Deviation 3
|
2.3 score on a scale
Standard Deviation 4.1
|
3.4 score on a scale
Standard Deviation 5.9
|
|
Modified Toronto Neuropathy Score (mTNS)
24 Months
|
4.4 score on a scale
Standard Deviation 6.4
|
2.6 score on a scale
Standard Deviation 2.9
|
1.4 score on a scale
Standard Deviation 1.9
|
3.2 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
SAS evaluates the presence and magnitude of autonomic symptoms. Total impact score ranges from 0-60 (or up to 55 for participants to whom certain criteria did not apply). Higher score indicates worse autonomic neuropathy
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Survey of Autonomic Symptoms (SAS)
Baseline
|
4.7 score on a scale
Standard Deviation 4.1
|
5 score on a scale
Standard Deviation 4.3
|
5.1 score on a scale
Standard Deviation 4.7
|
5.1 score on a scale
Standard Deviation 5.1
|
|
Survey of Autonomic Symptoms (SAS)
3 Months
|
8.2 score on a scale
Standard Deviation 8.3
|
4.9 score on a scale
Standard Deviation 4.2
|
3.4 score on a scale
Standard Deviation 3.8
|
4.8 score on a scale
Standard Deviation 4.3
|
|
Survey of Autonomic Symptoms (SAS)
12 Months
|
5.3 score on a scale
Standard Deviation 7.2
|
5.1 score on a scale
Standard Deviation 4.1
|
4.5 score on a scale
Standard Deviation 3.6
|
6.2 score on a scale
Standard Deviation 7.3
|
|
Survey of Autonomic Symptoms (SAS)
24 Months
|
5.3 score on a scale
Standard Deviation 7.1
|
8.4 score on a scale
Standard Deviation 4
|
5.3 score on a scale
Standard Deviation 5.3
|
6.2 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline, 3 month, 12 months and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
DNS is a questionnaire of neuropathy symptoms. Score ranges 0-4, \>/=1 indicates polyneuropathy. 0 indicates no polyneuropathy.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Diabetic Neuropathy Score (DNS)
Baseline
|
1.1 score on a scale
Standard Deviation 1.3
|
0.9 score on a scale
Standard Deviation 0.9
|
0.8 score on a scale
Standard Deviation 1
|
1.1 score on a scale
Standard Deviation 1.4
|
|
Diabetic Neuropathy Score (DNS)
3 Months
|
1.1 score on a scale
Standard Deviation 1.4
|
0.6 score on a scale
Standard Deviation 1
|
0.8 score on a scale
Standard Deviation 1.2
|
0.9 score on a scale
Standard Deviation 1.4
|
|
Diabetic Neuropathy Score (DNS)
12 Moths
|
1 score on a scale
Standard Deviation 1.3
|
0.6 score on a scale
Standard Deviation 0.9
|
0.8 score on a scale
Standard Deviation 1.2
|
0.9 score on a scale
Standard Deviation 1.1
|
|
Diabetic Neuropathy Score (DNS)
24 Months
|
1.3 score on a scale
Standard Deviation 1.5
|
0.6 score on a scale
Standard Deviation 1
|
0.7 score on a scale
Standard Deviation 0.8
|
1.1 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 12 months, 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Sum of the sensory score (0-30) and affective score (0-15) for a total score of 0-45. A higher score represents greater pain present.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Short Form McGill Pain Questionnaire
Baseline
|
3.7 score on a scale
Standard Deviation 4.4
|
3.1 score on a scale
Standard Deviation 4.4
|
2.7 score on a scale
Standard Deviation 4.1
|
3.5 score on a scale
Standard Deviation 5.5
|
|
Short Form McGill Pain Questionnaire
3 Months
|
3.8 score on a scale
Standard Deviation 7.7
|
2.1 score on a scale
Standard Deviation 3.6
|
2.6 score on a scale
Standard Deviation 4.2
|
3.5 score on a scale
Standard Deviation 6
|
|
Short Form McGill Pain Questionnaire
12 Months
|
3.3 score on a scale
Standard Deviation 8.5
|
2.3 score on a scale
Standard Deviation 3.4
|
2.4 score on a scale
Standard Deviation 2.8
|
2.6 score on a scale
Standard Deviation 4.5
|
|
Short Form McGill Pain Questionnaire
24 Months
|
5.2 score on a scale
Standard Deviation 6.6
|
2.5 score on a scale
Standard Deviation 4.5
|
2.1 score on a scale
Standard Deviation 2.6
|
2.2 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 12 months, 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Participant reported pain scale with range 0-10, higher score indicates more pain.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Numerical Rating Scale for Pain
Baseline
|
2.2 score on a scale
Standard Deviation 2.6
|
2.7 score on a scale
Standard Deviation 3.4
|
2.5 score on a scale
Standard Deviation 3.7
|
3.8 score on a scale
Standard Deviation 4
|
|
Numerical Rating Scale for Pain
3 Months
|
3.3 score on a scale
Standard Deviation 4.2
|
2.7 score on a scale
Standard Deviation 3.7
|
4.2 score on a scale
Standard Deviation 4.2
|
3.6 score on a scale
Standard Deviation 4.2
|
|
Numerical Rating Scale for Pain
12 Months
|
2.9 score on a scale
Standard Deviation 4.0
|
3.5 score on a scale
Standard Deviation 4.2
|
6.1 score on a scale
Standard Deviation 4.4
|
3.8 score on a scale
Standard Deviation 4.4
|
|
Numerical Rating Scale for Pain
24 Months
|
3.8 score on a scale
Standard Deviation 4.0
|
4.7 score on a scale
Standard Deviation 4.7
|
4.5 score on a scale
Standard Deviation 4.3
|
5 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 12 months, and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Neuropathy Quality of Life (NeuroQOL)
Baseline
|
2.62 NeuroQOL Score
Standard Deviation 2.34
|
2.13 NeuroQOL Score
Standard Deviation 1.12
|
2.1 NeuroQOL Score
Standard Deviation 0.94
|
2.71 NeuroQOL Score
Standard Deviation 1.98
|
|
Neuropathy Quality of Life (NeuroQOL)
3 Months
|
2.49 NeuroQOL Score
Standard Deviation 2.37
|
1.62 NeuroQOL Score
Standard Deviation 0.5
|
1.93 NeuroQOL Score
Standard Deviation 0.97
|
2.7 NeuroQOL Score
Standard Deviation 1.5
|
|
Neuropathy Quality of Life (NeuroQOL)
12 Months
|
2.23 NeuroQOL Score
Standard Deviation 2.48
|
1.62 NeuroQOL Score
Standard Deviation 0.43
|
2.21 NeuroQOL Score
Standard Deviation 0.87
|
2.42 NeuroQOL Score
Standard Deviation 1.26
|
|
Neuropathy Quality of Life (NeuroQOL)
24 Months
|
3.07 NeuroQOL Score
Standard Deviation 3.02
|
1.86 NeuroQOL Score
Standard Deviation 0.86
|
1.7 NeuroQOL Score
Standard Deviation 0.58
|
2.55 NeuroQOL Score
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 12 months, and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
This test measures in seconds how long it takes the participant to stand up from a seated position, walk around a cone places 8 feet away, and return to the chair and sit down. Less time indicates better speed, agility, and balance when moving.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
8 Foot Get Up and Go Test
Baseline
|
6.2 Seconds
Standard Deviation 1.5
|
6.1 Seconds
Standard Deviation 1
|
6.4 Seconds
Standard Deviation 1.2
|
6.6 Seconds
Standard Deviation 1.4
|
|
8 Foot Get Up and Go Test
3 Months
|
6 Seconds
Standard Deviation 1.1
|
5.9 Seconds
Standard Deviation 0.8
|
6.4 Seconds
Standard Deviation 1.3
|
6.8 Seconds
Standard Deviation 1.5
|
|
8 Foot Get Up and Go Test
12 Months
|
6.2 Seconds
Standard Deviation 1.2
|
5.6 Seconds
Standard Deviation 0.7
|
6.6 Seconds
Standard Deviation 1.6
|
6.8 Seconds
Standard Deviation 1.3
|
|
8 Foot Get Up and Go Test
24 Months
|
7.1 Seconds
Standard Deviation 3.9
|
6 Seconds
Standard Deviation 0.9
|
6.5 Seconds
Standard Deviation 1
|
7 Seconds
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 12 months, and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Berg Balance Scale measures participants' ability to balance and avoid falls. Scores range from 0-56, higher score indicates less likely to fall.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Berg Balance Scale
Baseline
|
55.41 score on a scale
Standard Deviation 1.16
|
55.53 score on a scale
Standard Deviation 1.02
|
55.41 score on a scale
Standard Deviation 1.16
|
54.57 score on a scale
Standard Deviation 1.93
|
|
Berg Balance Scale
3 Months
|
55.48 score on a scale
Standard Deviation 1.5
|
55.47 score on a scale
Standard Deviation 1.27
|
55.48 score on a scale
Standard Deviation 1.5
|
54.81 score on a scale
Standard Deviation 1.73
|
|
Berg Balance Scale
12 Months
|
54.88 score on a scale
Standard Deviation 2.12
|
55.41 score on a scale
Standard Deviation 1.48
|
54.88 score on a scale
Standard Deviation 2.12
|
54.65 score on a scale
Standard Deviation 1.6
|
|
Berg Balance Scale
24 Months
|
55.15 score on a scale
Standard Deviation 2.36
|
55.5 score on a scale
Standard Deviation 1.2
|
55.15 score on a scale
Standard Deviation 2.36
|
55 score on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 12 months, and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Patient response indicating if they have fallen in the last year. Data is shown as number of people who have fallen in the last year.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Modified Falls Efficacy Scale - Fall Evaluation
Baseline
|
8 Participants
|
9 Participants
|
9 Participants
|
12 Participants
|
|
Modified Falls Efficacy Scale - Fall Evaluation
3 Months
|
8 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
|
Modified Falls Efficacy Scale - Fall Evaluation
24 Months
|
6 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
|
Modified Falls Efficacy Scale - Fall Evaluation
12 Months
|
7 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 12 months, and 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Neurothesiometer is placed on the bottom of the great toe, and slowly increased until participant reports they can feel the vibration. The greater the microns, the less feeling the participant has, suggestive of worse sensory function. Value \> 25 Microns is indicative of neuropathy. There is no known maximum range. Lower values indicate better sensory function.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Neurothesiometer
Baseline
|
8.7 Microns
Standard Deviation 8.3
|
10.2 Microns
Standard Deviation 9
|
21.1 Microns
Standard Deviation 47.4
|
20.2 Microns
Standard Deviation 34.9
|
|
Neurothesiometer
3 Months
|
9.7 Microns
Standard Deviation 11.3
|
8 Microns
Standard Deviation 5.6
|
20.8 Microns
Standard Deviation 47.7
|
15.4 Microns
Standard Deviation 27
|
|
Neurothesiometer
12 Months
|
12.1 Microns
Standard Deviation 12.8
|
9.9 Microns
Standard Deviation 15
|
19.1 Microns
Standard Deviation 47.7
|
23.3 Microns
Standard Deviation 48.3
|
|
Neurothesiometer
24 Months
|
13.6 Microns
Standard Deviation 14.2
|
8 Microns
Standard Deviation 6.2
|
12 Microns
Standard Deviation 11.3
|
21.7 Microns
Standard Deviation 39.5
|
SECONDARY outcome
Timeframe: Baseline and at 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
NIH Toolbox Cognition Fluid (Range: 0-100) - Composite score derived as an average across five cognitive domains. It's a fully adjusted T-score comparing the participant to a nationally representative sample, stratified by age and other demographics. Individual domain scores are fully adjusted T score with range 0-100 and measures the following- * Inhibitory Control and Attention - executive function, attention . * Dimensional Change Card Sort - executive function * Picture Sequence Memory - episodic memory * List Sorting Working Memory - working memory * Pattern Comparison - processing speed A T-score of 50 represents the population mean. A score of 60 indicates that the participant is 1 SD above the national average for individuals with similar demographic characteristics Higher scores reflect better cognitive functionality. No set clinical threshold, scores above mean indicate above average cognition for a given age group.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
NIH Toolbox Cognitive Battery
Baseline Inhibitory Control and Attention Test
|
42.6 T-score
Standard Deviation 6.8
|
44 T-score
Standard Deviation 8.3
|
42.7 T-score
Standard Deviation 7.8
|
43 T-score
Standard Deviation 8.9
|
|
NIH Toolbox Cognitive Battery
Baseline Dimensional Change Card Sort Test
|
51.6 T-score
Standard Deviation 12.9
|
54.6 T-score
Standard Deviation 11.5
|
54.5 T-score
Standard Deviation 13.2
|
51.8 T-score
Standard Deviation 12.3
|
|
NIH Toolbox Cognitive Battery
Baseline Picture Sequence Memory Test
|
56.2 T-score
Standard Deviation 11.8
|
55.8 T-score
Standard Deviation 12.2
|
55.6 T-score
Standard Deviation 12
|
54.2 T-score
Standard Deviation 8.5
|
|
NIH Toolbox Cognitive Battery
Baseline List Sorting Working Memory Test
|
54.8 T-score
Standard Deviation 10.1
|
51.7 T-score
Standard Deviation 9.3
|
53.3 T-score
Standard Deviation 10.8
|
50.3 T-score
Standard Deviation 8.2
|
|
NIH Toolbox Cognitive Battery
Baseline Pattern Comparison Processing Speed Test
|
48.9 T-score
Standard Deviation 13.1
|
49.4 T-score
Standard Deviation 12.2
|
51 T-score
Standard Deviation 15
|
50.4 T-score
Standard Deviation 13.9
|
|
NIH Toolbox Cognitive Battery
Baseline Cognition Fluid Composite
|
51.2 T-score
Standard Deviation 12.3
|
51.6 T-score
Standard Deviation 11.8
|
52.1 T-score
Standard Deviation 11.2
|
49.8 T-score
Standard Deviation 11.3
|
|
NIH Toolbox Cognitive Battery
24 Months Inhibitory Control and Attention Test
|
42.9 T-score
Standard Deviation 9.3
|
44.3 T-score
Standard Deviation 7.6
|
44.2 T-score
Standard Deviation 8.2
|
43.9 T-score
Standard Deviation 8.5
|
|
NIH Toolbox Cognitive Battery
24 Months Dimensional Change Card Sort Test
|
53.7 T-score
Standard Deviation 12.5
|
53.7 T-score
Standard Deviation 13.5
|
56.7 T-score
Standard Deviation 11
|
54.6 T-score
Standard Deviation 10.9
|
|
NIH Toolbox Cognitive Battery
24 Months Picture Sequence Memory Test
|
55.9 T-score
Standard Deviation 10.8
|
54.7 T-score
Standard Deviation 13
|
58.7 T-score
Standard Deviation 10.8
|
56.3 T-score
Standard Deviation 10.8
|
|
NIH Toolbox Cognitive Battery
24 Months List Sorting Working Memory Test
|
56.6 T-score
Standard Deviation 10.1
|
52.1 T-score
Standard Deviation 8.6
|
54.4 T-score
Standard Deviation 7.5
|
50.7 T-score
Standard Deviation 11.4
|
|
NIH Toolbox Cognitive Battery
24 Months Pattern Comparison Processing Speed Test
|
52.7 T-score
Standard Deviation 13.8
|
46.7 T-score
Standard Deviation 16.7
|
48.8 T-score
Standard Deviation 13.4
|
47.3 T-score
Standard Deviation 15.7
|
|
NIH Toolbox Cognitive Battery
24 Months Cognition Fluid Composite
|
53.5 T-score
Standard Deviation 12.2
|
50.4 T-score
Standard Deviation 11.2
|
53.9 T-score
Standard Deviation 9.1
|
50.6 T-score
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline and at 24 monthsPopulation: The number analyzed the number of participants that completed the outcome at each respective visit. This number will not include participants dropped out, missed a visit, or declined the particular outcome measure.
Used to evaluate verbal learning and memory using a list of 15 unrelated words presented to the participant over repeat trial. Includes 3 independent scales: * Auditory Learning (Total recall) - Measures memory and learning ability. Raw score range (0- 75) * Delayed Recall - Measures long term memory retention. Raw score range (0-15) * Recognition - Measures ability to recognize previously learned information. Raw score range (0-15). * Raw scores were converted to age-standardized Z-scores using 10-year age bands (e.g., 20-29, 30-39, 40-49, etc.), with a mean of 0 and standard deviation of 1. * A Z-score of 0 represents the population mean * For each scale, scores above 0 are better. Standard deviations above the mean indicates a better learning and memory ability for a given age group. No set clinical threshold, scores above mean indicate above average cognition for a given age group.
Outcome measures
| Measure |
Bariatric Surgery/HIIT
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Bariatric surgery: Patients will undergo bariatric surgery as part of their routine care
|
No Bariatric Surgery/HIIT
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a high intensity interval training (HIIT) protocol for 24 months. Patients will complete 2 supervised HIIT sessions and 1 unsupervised HIIT session a week.
High Intensity Interval Training (HIIT): Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
|
No Bariatric Surgery/Routine Exercise
n=35 Participants
Patients who have not undergone bariatric surgery will be randomized to this arm and will follow a standard routine exercise regimen for 24 months.
Routine Exercise: Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
|
|---|---|---|---|---|
|
Rey Auditory Verbal Learning Test
Baseline Auditory Learning
|
0.1 Z-score
Standard Deviation 1.2
|
0.3 Z-score
Standard Deviation 1.2
|
0.4 Z-score
Standard Deviation 0.8
|
0.4 Z-score
Standard Deviation 1
|
|
Rey Auditory Verbal Learning Test
Baseline Delayed Recall
|
0 Z-score
Standard Deviation 1.1
|
-0.2 Z-score
Standard Deviation 1.1
|
0.1 Z-score
Standard Deviation 0.9
|
-0.1 Z-score
Standard Deviation 1
|
|
Rey Auditory Verbal Learning Test
Baseline Recognition
|
0.7 Z-score
Standard Deviation 0.8
|
0.6 Z-score
Standard Deviation 0.8
|
0.7 Z-score
Standard Deviation 1.2
|
0.7 Z-score
Standard Deviation 0.9
|
|
Rey Auditory Verbal Learning Test
24 Months Auditory Learning
|
-0.2 Z-score
Standard Deviation 1.3
|
0.2 Z-score
Standard Deviation 1.2
|
0.4 Z-score
Standard Deviation 1
|
0 Z-score
Standard Deviation 1.1
|
|
Rey Auditory Verbal Learning Test
24 Months Delayed Recall
|
-0.4 Z-score
Standard Deviation 1
|
-0.1 Z-score
Standard Deviation 1
|
0.2 Z-score
Standard Deviation 0.9
|
-0.1 Z-score
Standard Deviation 1.1
|
|
Rey Auditory Verbal Learning Test
24 Months Recognition
|
0.6 Z-score
Standard Deviation 1.2
|
0.9 Z-score
Standard Deviation 0.8
|
0.8 Z-score
Standard Deviation 1.2
|
0 Z-score
Standard Deviation 1
|
Adverse Events
Bariatric Surgery/HIIT
No Bariatric Surgery/HIIT
Bariatric Surgery/Routine Exercise
No Bariatric Surgery/Routine Exercise
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bariatric Surgery/HIIT
n=35 participants at risk
High Intensity Interval Training (HIIT) Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Procedure/Surgery: Bariatric surgery Patients will undergo bariatric surgery as part of their routine care.
|
No Bariatric Surgery/HIIT
n=35 participants at risk
High Intensity Interval Training (HIIT) Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
Procedure/Surgery: None
|
Bariatric Surgery/Routine Exercise
n=35 participants at risk
Routine Exercise Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Procedure/Surgery: Bariatric surgery Patients will undergo bariatric surgery as part of their routine care.
|
No Bariatric Surgery/Routine Exercise
n=35 participants at risk
Routine Exercise Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
Procedure/Surgery: None
|
|---|---|---|---|---|
|
Infections and infestations
Infection at Skin Biopsy Site
|
0.00%
0/35 • 2 years
Participants who withdrew from the study were not tracked after their withdrawal date
|
2.9%
1/35 • Number of events 1 • 2 years
Participants who withdrew from the study were not tracked after their withdrawal date
|
2.9%
1/35 • Number of events 1 • 2 years
Participants who withdrew from the study were not tracked after their withdrawal date
|
0.00%
0/35 • 2 years
Participants who withdrew from the study were not tracked after their withdrawal date
|
|
Injury, poisoning and procedural complications
Injury During Exercise
|
0.00%
0/35 • 2 years
Participants who withdrew from the study were not tracked after their withdrawal date
|
2.9%
1/35 • Number of events 1 • 2 years
Participants who withdrew from the study were not tracked after their withdrawal date
|
0.00%
0/35 • 2 years
Participants who withdrew from the study were not tracked after their withdrawal date
|
0.00%
0/35 • 2 years
Participants who withdrew from the study were not tracked after their withdrawal date
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place