Trial Outcomes & Findings for Home Exercise to Enhance Mobility for Older Diabetics (NCT NCT01308008)
NCT ID: NCT01308008
Last Updated: 2018-11-08
Results Overview
Gait velocity over 6 meters
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
1 year
Results posted on
2018-11-08
Participant Flow
Participants were recruited in Ann Arbor, Michigan and surrounding communities. Recruitment relied primarily on media advertisement, community outreach and mailings to patients with diabetes treated at the Veterans Affairs Ann Arbor Healthcare System (VAAAHS) and the University of Michigan (UM), both of which provided IRB approval.
Withdrawal after Screening, prior to Baseline: N=5
Participant milestones
| Measure |
Functional Exercise- Home Physical Activity
Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
|
Flex and Tone- Home Health Education
Initial on-site flex and toning program continued on follow-up along with health education
|
|---|---|---|
|
4 Weeks
STARTED
|
71
|
73
|
|
4 Weeks
COMPLETED
|
62
|
71
|
|
4 Weeks
NOT COMPLETED
|
9
|
2
|
|
6 Months
STARTED
|
62
|
71
|
|
6 Months
COMPLETED
|
54
|
62
|
|
6 Months
NOT COMPLETED
|
8
|
9
|
|
12 Months
STARTED
|
54
|
62
|
|
12 Months
COMPLETED
|
46
|
58
|
|
12 Months
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
Functional Exercise- Home Physical Activity
Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
|
Flex and Tone- Home Health Education
Initial on-site flex and toning program continued on follow-up along with health education
|
|---|---|---|
|
4 Weeks
Illness, disinterest, time
|
9
|
2
|
Baseline Characteristics
Home Exercise to Enhance Mobility for Older Diabetics
Baseline characteristics by cohort
| Measure |
Functional Exercise- Home Physical Activity
n=71 Participants
On-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with telephonic behavioral support
home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
|
Flex and Tone- Home Health Education
n=73 Participants
Initial on-site flex and toning program continued on follow-up along with health education
flex and toning health education program: Initial flex and toning program continued on follow-up along with health education
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
71 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
144 Participants
n=27 Participants
|
|
Age, Continuous
|
69 Years
STANDARD_DEVIATION 6 • n=93 Participants
|
70 Years
STANDARD_DEVIATION 6 • n=4 Participants
|
70 Years
STANDARD_DEVIATION 6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
96 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Comfortable gait speed
|
1.1 meters per second
STANDARD_DEVIATION 0.2 • n=93 Participants
|
1.1 meters per second
STANDARD_DEVIATION 0.2 • n=4 Participants
|
1.1 meters per second
STANDARD_DEVIATION 0.2 • n=27 Participants
|
PRIMARY outcome
Timeframe: 1 yearGait velocity over 6 meters
Outcome measures
| Measure |
Functional Exercise- Home Physical Activity
n=71 Participants
Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
|
Flex and Tone- Home Health Education
n=73 Participants
Initial on-site flex and toning program continued on follow-up along with health education
|
|---|---|---|
|
Comfortable Gait Speed
|
1.2 meters per second
Standard Deviation 0.2
|
1.2 meters per second
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: one yearWalk distance covered in feet over 6 minutes
Outcome measures
| Measure |
Functional Exercise- Home Physical Activity
n=71 Participants
Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
|
Flex and Tone- Home Health Education
n=73 Participants
Initial on-site flex and toning program continued on follow-up along with health education
|
|---|---|---|
|
Six Minute Walk Distance
|
1307 feet
Standard Deviation 234
|
1271 feet
Standard Deviation 275
|
SECONDARY outcome
Timeframe: one yearAverage physical activity counts per waking minute
Outcome measures
| Measure |
Functional Exercise- Home Physical Activity
n=71 Participants
Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
home exercise/physical activity (PA) enhancement program with behavioral support: Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
|
Flex and Tone- Home Health Education
n=73 Participants
Initial on-site flex and toning program continued on follow-up along with health education
|
|---|---|---|
|
Physical Activity
|
170 counts per minute
Standard Deviation 89
|
141 counts per minute
Standard Deviation 66
|
Adverse Events
Functional Exercise- Home Physical Activity
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Flex and Tone- Home Health Education
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Functional Exercise- Home Physical Activity
n=71 participants at risk
Functional exercise- home physical activity
|
Flex and Tone- Home Health Education
n=73 participants at risk
Flex and tone- health education
|
|---|---|---|
|
Infections and infestations
Sepsis
|
1.4%
1/71 • Number of events 1
|
0.00%
0/73
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/71
|
1.4%
1/73 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer
|
0.00%
0/71
|
1.4%
1/73 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperkalemia
|
1.4%
1/71 • Number of events 1
|
0.00%
0/73
|
|
Musculoskeletal and connective tissue disorders
Partial achilles tendon tear
|
1.4%
1/71 • Number of events 1
|
0.00%
0/73
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colonic polyp
|
0.00%
0/71
|
1.4%
1/73 • Number of events 1
|
Other adverse events
| Measure |
Functional Exercise- Home Physical Activity
n=71 participants at risk
Functional exercise- home physical activity
|
Flex and Tone- Home Health Education
n=73 participants at risk
Flex and tone- health education
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Baker's cyst drainage
|
0.00%
0/71
|
1.4%
1/73 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
hand pain
|
0.00%
0/71
|
1.4%
1/73 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place