Trial Outcomes & Findings for The Therapeutic Effects of Forced Aerobic Exercise in Multiple Sclerosis (NCT NCT04906057)
NCT ID: NCT04906057
Last Updated: 2025-03-06
Results Overview
Average exercise duration
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
collected during each exercise session (twice per week for 12 weeks)
Results posted on
2025-03-06
Participant Flow
Participant milestones
| Measure |
Forced Aerobic Exercise (FE)
The FE group (N=11) completed 45 minutes of forced-rate aerobic exercise on a custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Aerobic Exercise (VE)
The VE group (N=7) completed aerobic exercise on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
11
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
Baseline characteristics by cohort
| Measure |
Forced Aerobic Exercise (FE)
n=11 Participants
The FE group (N=11) completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Aerobic Exercise (VE)
n=7 Participants
The VE group (N=7) completed exercise on an identical semi-recumbent cycle ergometer for 45 minutes at their self-selected cadence without assistance.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
7 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
16 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
2 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
56.9 years
STANDARD_DEVIATION 7.9 • n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
54.9 years
STANDARD_DEVIATION 10.6 • n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
4 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
10 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
3 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
8 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
1 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
7 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
17 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=7 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
0 Participants
n=5 Participants • 1. Participants withdrew due to unrelated injury 2. Participants withdrew due to Covid-19 1 Participant withdrew due to Covid-19
|
PRIMARY outcome
Timeframe: collected during each exercise session (twice per week for 12 weeks)Population: Completed participants in the FE \& VE groups.
Average exercise duration
Outcome measures
| Measure |
Forced Aerobic Exercise (FE)
n=11 Participants
Results from this section include data from the Forced Exercise
The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Exercise (VE)
n=7 Participants
The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer
|
|---|---|---|
|
Exercise Duration
|
42.2 Minutes
Standard Deviation 2.4
|
42.2 Minutes
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Collected during each exercise session (twice per week for 12 weeks)Population: FE + VE groups
average percent max heart rate
Outcome measures
| Measure |
Forced Aerobic Exercise (FE)
n=11 Participants
Results from this section include data from the Forced Exercise
The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Exercise (VE)
n=7 Participants
The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer
|
|---|---|---|
|
Aerobic Intensity
|
0.63 % Max HR
Standard Deviation 0.07
|
.70 % Max HR
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: collected during each exercise session (twice per week for 12 weeks)Population: Completed participants within the FE \& VE groups
Average Exercise Cadence (cycling rate)
Outcome measures
| Measure |
Forced Aerobic Exercise (FE)
n=11 Participants
Results from this section include data from the Forced Exercise
The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Exercise (VE)
n=7 Participants
The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer
|
|---|---|---|
|
Exercise Cadence
|
69.1 revolutions per minute
Standard Deviation 11.1
|
64.5 revolutions per minute
Standard Deviation 16.7
|
PRIMARY outcome
Timeframe: Week 0 (baseline), Week 13 (post exercise sessions)Population: Week (0) Baseline + EOT Week (13)
The distance walked over 6 minutes is measured on an oval walking track
Outcome measures
| Measure |
Forced Aerobic Exercise (FE)
n=11 Participants
Results from this section include data from the Forced Exercise
The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Exercise (VE)
n=7 Participants
The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer
|
|---|---|---|
|
Six Minute Walk Test
Baseline
|
339.1 Meters
Standard Deviation 123.3
|
345.9 Meters
Standard Deviation 110.7
|
|
Six Minute Walk Test
EOT
|
338.3 Meters
Standard Deviation 111.5
|
373.6 Meters
Standard Deviation 128.6
|
PRIMARY outcome
Timeframe: Week 0 (baseline), Week 13 (post exercise sessions)Population: Data was obtained using a ZENO \& Caren walking pad; however, one participant was unable to complete this outcome measure due to unsteady gait.
Spatio-temporal and kinematic parameters of gait will be obtained using 3-D motion capture and an instrumented walkway.
Outcome measures
| Measure |
Forced Aerobic Exercise (FE)
n=10 Participants
Results from this section include data from the Forced Exercise
The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Exercise (VE)
n=7 Participants
The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer
|
|---|---|---|
|
Gait Velocity
Zeno Velocity Self-Paced Baseline (average)
|
90.6 Meters per second
Standard Deviation 17.3
|
91.5 Meters per second
Standard Deviation 30.6
|
|
Gait Velocity
Zeno Velocity Fast-Paced Baseline (average)
|
122.4 Meters per second
Standard Deviation 19.3
|
131.0 Meters per second
Standard Deviation 13.0
|
|
Gait Velocity
CAREN Walking Speed Baseline (Average)
|
0.54 Meters per second
Standard Deviation .28
|
0.65 Meters per second
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: Week 0 (baseline), Week 13 (post exercise sessions)Population: Each participant completed the PROMIS-29 assessment at baseline. Some participants chose not to complete the EOT questionnaire, hence the overall number of participants for the EOT testing is fewer than the baseline.
The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in the general population and with individuals living with chronic conditions. Raw scores were converted to T-scores (using an adult referent population) ranging from 0-100 with a mean of 50 and standard deviation (SD) of 10 in the referent population. For the PROMIS-29 symptom-related domains (anxiety, depression, fatigue, sleep disturbance, and pain interference), higher scores represent greater symptom burden (worse function). For the physical and participation domains, higher scores represent greater levels of function. Pain intensity is scored separately using a 0-10 scaler with higher scores representing greater pain.
Outcome measures
| Measure |
Forced Aerobic Exercise (FE)
n=11 Participants
Results from this section include data from the Forced Exercise
The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Exercise (VE)
n=7 Participants
The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer
|
|---|---|---|
|
PROMIS-29
PROMIS Anxiety at EOT
|
45.8 Units on a scale
Standard Deviation 6.3
|
45.6 Units on a scale
Standard Deviation 7.3
|
|
PROMIS-29
PROMIS Depression at baseline
|
46.1 Units on a scale
Standard Deviation 7.8
|
46.5 Units on a scale
Standard Deviation 10.8
|
|
PROMIS-29
PROMIS Fatigue at EOT
|
48.6 Units on a scale
Standard Deviation 11.0
|
47.9 Units on a scale
Standard Deviation 3.3
|
|
PROMIS-29
PROMIS Participation at baseline
|
50.5 Units on a scale
Standard Deviation 7.0
|
49.2 Units on a scale
Standard Deviation 7.9
|
|
PROMIS-29
PROMIS Physical at baseline
|
40.2 Units on a scale
Standard Deviation 7.8
|
40.8 Units on a scale
Standard Deviation 7.8
|
|
PROMIS-29
PROMIS Physical at EOT
|
40.0 Units on a scale
Standard Deviation 6.0
|
40.0 Units on a scale
Standard Deviation 5.0
|
|
PROMIS-29
PROMIS Anxiety at baseline
|
46.6 Units on a scale
Standard Deviation 7.6
|
49.5 Units on a scale
Standard Deviation 12.3
|
|
PROMIS-29
PROMIS Depression at EOT
|
45.7 Units on a scale
Standard Deviation 7.7
|
45.8 Units on a scale
Standard Deviation 6.6
|
|
PROMIS-29
PROMIS Fatigue at baseline
|
50.8 Units on a scale
Standard Deviation 11.5
|
53.5 Units on a scale
Standard Deviation 5.2
|
|
PROMIS-29
PROMIS Sleep Disturbance at baseline
|
43.2 Units on a scale
Standard Deviation 5.4
|
45.8 Units on a scale
Standard Deviation 9.8
|
|
PROMIS-29
PROMIS Sleep Disturbance at EOT
|
42.9 Units on a scale
Standard Deviation 6.1
|
44.9 Units on a scale
Standard Deviation 7.8
|
|
PROMIS-29
PROMIS Participation at EOT
|
53.6 Units on a scale
Standard Deviation 8.8
|
52.0 Units on a scale
Standard Deviation 8.1
|
|
PROMIS-29
PROMIS Pain Interference at baseline
|
52.7 Units on a scale
Standard Deviation 10.4
|
54.9 Units on a scale
Standard Deviation 7.2
|
|
PROMIS-29
PROMIS Pain Interference at EOT
|
46.5 Units on a scale
Standard Deviation 8.2
|
50.1 Units on a scale
Standard Deviation 7.7
|
|
PROMIS-29
PROMIS Pain Intensity at baseline
|
3.5 Units on a scale
Standard Deviation 2.7
|
4.1 Units on a scale
Standard Deviation 1.6
|
|
PROMIS-29
PROMIS Pain Intensity at EOT
|
2.6 Units on a scale
Standard Deviation 1.8
|
3.2 Units on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Week 0 (baseline), Week 13 (post exercise sessions)Population: Each participant completed the Modified Fatigue Impact Scale (MFIS) assessment at baseline. Some participants chose not to complete the EOT questionnaire, hence the overall number of participants for the EOT testing is fewer than the baseline.
The MFIS is a 21-item self-reported measure of how fatigue impacts the lives of persons with multiple sclerosis. This instrument provides an assessment of the effects of fatigue as it relates to physical, cognitive, and psychosocial functioning. Participants rate on a 5-point Likert scale, with 0 = 'Never' to 4 = 'Almost always' their agreement with 21 statements. Total score (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8). Higher numbers indicate greater fatigue in all domains.
Outcome measures
| Measure |
Forced Aerobic Exercise (FE)
n=11 Participants
Results from this section include data from the Forced Exercise
The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Exercise (VE)
n=7 Participants
The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer
|
|---|---|---|
|
Modified Fatigue Impact Scale (MFIS)
MFIS Cognitive Subscale at baseline
|
7.6 score on Likert scale
Standard Deviation 7.4
|
12.3 score on Likert scale
Standard Deviation 7.3
|
|
Modified Fatigue Impact Scale (MFIS)
MFIS total score at baseline
|
21.9 score on Likert scale
Standard Deviation 18.5
|
33.4 score on Likert scale
Standard Deviation 12.8
|
|
Modified Fatigue Impact Scale (MFIS)
MFIS total score at EOT
|
18.6 score on Likert scale
Standard Deviation 18.7
|
20.2 score on Likert scale
Standard Deviation 7.5
|
|
Modified Fatigue Impact Scale (MFIS)
MFIS Physical Subscale at baseline
|
14.0 score on Likert scale
Standard Deviation 10.6
|
18.7 score on Likert scale
Standard Deviation 6.9
|
|
Modified Fatigue Impact Scale (MFIS)
MFIS Physical Subscale at EOT
|
9.9 score on Likert scale
Standard Deviation 10.3
|
11.8 score on Likert scale
Standard Deviation 3.6
|
|
Modified Fatigue Impact Scale (MFIS)
MFIS Cognitive Subscale at EOT
|
7.2 score on Likert scale
Standard Deviation 6.9
|
6.8 score on Likert scale
Standard Deviation 6.6
|
|
Modified Fatigue Impact Scale (MFIS)
MFIS Psychosocial Subscale at baseline
|
2.0 score on Likert scale
Standard Deviation 1.90
|
2.3 score on Likert scale
Standard Deviation 2.1
|
|
Modified Fatigue Impact Scale (MFIS)
MFIS Psychosocial Subscale at EOT
|
1.5 score on Likert scale
Standard Deviation 1.7
|
1.6 score on Likert scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Week 0 (baseline), Week 13 (post exercise sessions)Population: One forced exercise participant was unable to complete the Manual Dexterity test on the left side at baseline.
Assessment examining cognitive and hand function for persons with MS
Outcome measures
| Measure |
Forced Aerobic Exercise (FE)
n=11 Participants
Results from this section include data from the Forced Exercise
The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Exercise (VE)
n=7 Participants
The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer
|
|---|---|---|
|
Multiple Sclerosis Manual Dexterity Test
Manual Dexterity Test (right) at EOT
|
32.4 Time in Seconds
Standard Deviation 7.8
|
23.9 Time in Seconds
Standard Deviation 4.4
|
|
Multiple Sclerosis Manual Dexterity Test
Manual Dexterity Test (Right) at baseline
|
31.4 Time in Seconds
Standard Deviation 8.2
|
24.3 Time in Seconds
Standard Deviation 4.1
|
|
Multiple Sclerosis Manual Dexterity Test
Manual Dexterity Test (Left) at baseline
|
33.8 Time in Seconds
Standard Deviation 5.8
|
25.4 Time in Seconds
Standard Deviation 2.0
|
|
Multiple Sclerosis Manual Dexterity Test
Manual Dexterity Test (left) at EOT
|
35.4 Time in Seconds
Standard Deviation 9.8
|
39.6 Time in Seconds
Standard Deviation 35.9
|
PRIMARY outcome
Timeframe: Week 0 (baseline), Week 13 (post exercise sessions)Population: One participant from the VE group could not complete the processing speed test.
Assessment examining processing speed using an tablet-based measure developed to closely resemble the symbol digit modalities test. Participants match symbols to digits over a 2-minute trial. The number of correct matches represents the score, with higher correct matches indicative of better processing speed performance. The low range of possible scoring is 0 with no upper range limit. In a study by Rao and colleagues (2017), persons with MS scored and average of 51.1 (+/- 11.9) on the first trial and 52.8 (+/- 2.0) on the second trial. One trial was conducted in this study.
Outcome measures
| Measure |
Forced Aerobic Exercise (FE)
n=10 Participants
Results from this section include data from the Forced Exercise
The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Exercise (VE)
n=7 Participants
The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer
|
|---|---|---|
|
Processing Speed Test
Processing speed test total correct at baseline
|
43.0 number correct
Standard Deviation 8.0
|
55.3 number correct
Standard Deviation 8.5
|
|
Processing Speed Test
Processing speed test total correct at EOT
|
45.1 number correct
Standard Deviation 9.4
|
57.4 number correct
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Week 1 (exercise session 1), Week 12 (exercise session 24)Population: Participants in this data set have completed the entire 12 weeks of the prescribed exercise session.
Laboratory Assessment: Blood draws will be conducted at 4 different points in time to determine the acute and long-term change in serum Klotho; at week one session one, pre- and post-exercise, and at the last session12-week exercise intervention, pre- and post-exercise.
Outcome measures
| Measure |
Forced Aerobic Exercise (FE)
n=12 Participants
Results from this section include data from the Forced Exercise
The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Exercise (VE)
n=6 Participants
The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer
|
|---|---|---|
|
To Investigate the Role of Klotho in Promoting Neuroprotection.
Klotho (Baseline Pre-Exercise)
|
1273.3 pg/mL
Standard Deviation 787.7
|
1100.4 pg/mL
Standard Deviation 878.0
|
|
To Investigate the Role of Klotho in Promoting Neuroprotection.
Klotho (Baseline Post-Exercise)
|
929.5 pg/mL
Standard Deviation 661.1
|
1166.4 pg/mL
Standard Deviation 745.4
|
|
To Investigate the Role of Klotho in Promoting Neuroprotection.
Klotho (Final Session pre-exercise)
|
948.3 pg/mL
Standard Deviation 550.2
|
1019.4 pg/mL
Standard Deviation 608.7
|
|
To Investigate the Role of Klotho in Promoting Neuroprotection.
Klotho (Final Session post-exercise)
|
1265.8 pg/mL
Standard Deviation 940.2
|
154.4 pg/mL
Standard Deviation 1104.1
|
|
To Investigate the Role of Klotho in Promoting Neuroprotection.
Neurofilament light (Baseline)
|
14.6 pg/mL
Standard Deviation 7.5
|
14.5 pg/mL
Standard Deviation 7.3
|
|
To Investigate the Role of Klotho in Promoting Neuroprotection.
Neurofilament light (Final Session)
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16.5 pg/mL
Standard Deviation 6.4
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15.0 pg/mL
Standard Deviation 4.0
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Adverse Events
Forced Aerobic Exercise (FE)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Voluntary Aerobic Exercise (VE)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Forced Aerobic Exercise (FE)
n=12 participants at risk
This section includes data from all randomized participants in the forced exercise group
The FE group (N=12) completed 45 minutes of FE on the custom-engineered cycle designed to augment the pedaling rate to greater than 70 revolutions per minute (RPM's). The VE group (N=10) will exercise on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance.
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
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Voluntary Aerobic Exercise (VE)
n=10 participants at risk
This section includes data from all randomized participants in the the voluntary exercise group
The VE group (N=10) completed the exercise on an identical semi-recumbent cycle ergometer for 45 minutes at their self-selected cadence without assistance.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer
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|---|---|---|
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Cardiac disorders
STEMI
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8.3%
1/12 • Number of events 1 • Adverse experiences were collected up to 19 weeks from start to completion of the study.
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0.00%
0/10 • Adverse experiences were collected up to 19 weeks from start to completion of the study.
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Other adverse events
| Measure |
Forced Aerobic Exercise (FE)
n=12 participants at risk
This section includes data from all randomized participants in the forced exercise group
The FE group (N=12) completed 45 minutes of FE on the custom-engineered cycle designed to augment the pedaling rate to greater than 70 revolutions per minute (RPM's). The VE group (N=10) will exercise on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance.
Forced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
|
Voluntary Aerobic Exercise (VE)
n=10 participants at risk
This section includes data from all randomized participants in the the voluntary exercise group
The VE group (N=10) completed the exercise on an identical semi-recumbent cycle ergometer for 45 minutes at their self-selected cadence without assistance.
Voluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer
|
|---|---|---|
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Respiratory, thoracic and mediastinal disorders
Covid-19 Diagnosis
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8.3%
1/12 • Number of events 1 • Adverse experiences were collected up to 19 weeks from start to completion of the study.
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30.0%
3/10 • Number of events 3 • Adverse experiences were collected up to 19 weeks from start to completion of the study.
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Injury, poisoning and procedural complications
Fall
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8.3%
1/12 • Number of events 1 • Adverse experiences were collected up to 19 weeks from start to completion of the study.
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10.0%
1/10 • Number of events 1 • Adverse experiences were collected up to 19 weeks from start to completion of the study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place