The Therapeutic Effects of Forced Aerobic Exercise in Multiple Scleros
The Therapeutic Effects of Forced Aerobic Exercise in Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Forced Aerobic Exercise (FE)
Compared with
- Voluntary Aerobic Exercise (VE)
Results by group
Exercise Duration
collected during each exercise session (twice per week for 12 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Forced Aerobic Exercise (FE) | 42.2 Minutes | 2.4 (Standard Deviation) | 11 |
| Voluntary Exercise (VE) | 42.2 Minutes | 2.4 (Standard Deviation) | 7 |
Forced Aerobic Exercise (FE)
Voluntary Exercise (VE)
Aerobic Intensity
Collected during each exercise session (twice per week for 12 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Forced Aerobic Exercise (FE) | 0.63 % Max HR | 0.07 (Standard Deviation) | 11 |
| Voluntary Exercise (VE) | .70 % Max HR | 0.05 (Standard Deviation) | 7 |
Forced Aerobic Exercise (FE)
Voluntary Exercise (VE)
Exercise Cadence
collected during each exercise session (twice per week for 12 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Forced Aerobic Exercise (FE) | 69.1 revolutions per minute | 11.1 (Standard Deviation) | 11 |
| Voluntary Exercise (VE) | 64.5 revolutions per minute | 16.7 (Standard Deviation) | 7 |
Forced Aerobic Exercise (FE)
Voluntary Exercise (VE)
Six Minute Walk Test
Week 0 (baseline), Week 13 (post exercise sessions)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Forced Aerobic Exercise (FE) | 339.1 Meters | 123.3 (Standard Deviation) | 11 |
| Voluntary Exercise | 345.9 Meters | 110.7 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 338.3 Meters | 111.5 (Standard Deviation) | 11 |
| Voluntary Exercise | 373.6 Meters | 128.6 (Standard Deviation) | 7 |
Forced Aerobic Exercise (FE)
Voluntary Exercise
Forced Aerobic Exercise (FE)
Voluntary Exercise
Gait Velocity
Week 0 (baseline), Week 13 (post exercise sessions)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Forced Aerobic Exercise (FE) | 90.6 Meters per second | 17.3 (Standard Deviation) | 10 |
| Voluntary Exercise | 91.5 Meters per second | 30.6 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 122.4 Meters per second | 19.3 (Standard Deviation) | 10 |
| Voluntary Exercise | 131.0 Meters per second | 13 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 0.54 Meters per second | 0.28 (Standard Deviation) | 10 |
| Voluntary Exercise | 0.65 Meters per second | 0.3 (Standard Deviation) | 7 |
PROMIS-29
Week 0 (baseline), Week 13 (post exercise sessions)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 40.2 Units on a scale | 7.8 (Standard Deviation) | 11 |
| Voluntary Exercise | 40.8 Units on a scale | 7.8 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 40.0 Units on a scale | 6 (Standard Deviation) | 11 |
| Voluntary Exercise | 40.0 Units on a scale | 5 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 46.6 Units on a scale | 7.6 (Standard Deviation) | 11 |
| Voluntary Exercise | 49.5 Units on a scale | 12.3 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 45.8 Units on a scale | 6.3 (Standard Deviation) | 11 |
| Voluntary Exercise | 45.6 Units on a scale | 7.3 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 46.1 Units on a scale | 7.8 (Standard Deviation) | 11 |
| Voluntary Exercise | 46.5 Units on a scale | 10.8 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 45.7 Units on a scale | 7.7 (Standard Deviation) | 11 |
| Voluntary Exercise | 45.8 Units on a scale | 6.6 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 50.8 Units on a scale | 11.5 (Standard Deviation) | 11 |
| Voluntary Exercise | 53.5 Units on a scale | 5.2 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 48.6 Units on a scale | 11 (Standard Deviation) | 11 |
| Voluntary Exercise | 47.9 Units on a scale | 3.3 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 43.2 Units on a scale | 5.4 (Standard Deviation) | 11 |
| Voluntary Exercise | 45.8 Units on a scale | 9.8 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 42.9 Units on a scale | 6.1 (Standard Deviation) | 11 |
| Voluntary Exercise | 44.9 Units on a scale | 7.8 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 50.5 Units on a scale | 7 (Standard Deviation) | 11 |
| Voluntary Exercise | 49.2 Units on a scale | 7.9 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 53.6 Units on a scale | 8.8 (Standard Deviation) | 11 |
| Voluntary Exercise | 52.0 Units on a scale | 8.1 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 52.7 Units on a scale | 10.4 (Standard Deviation) | 11 |
| Voluntary Exercise | 54.9 Units on a scale | 7.2 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 46.5 Units on a scale | 8.2 (Standard Deviation) | 11 |
| Voluntary Exercise | 50.1 Units on a scale | 7.7 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 3.5 Units on a scale | 2.7 (Standard Deviation) | 11 |
| Voluntary Exercise | 4.1 Units on a scale | 1.6 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) + Voluntary Exercise (VE) | 2.6 Units on a scale | 1.8 (Standard Deviation) | 11 |
| Voluntary Exercise | 3.2 Units on a scale | 1.9 (Standard Deviation) | 7 |
Modified Fatigue Impact Scale (MFIS)
Week 0 (baseline), Week 13 (post exercise sessions)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Forced Aerobic Exercise (FE) | 21.9 score on Likert scale | 18.5 (Standard Deviation) | 11 |
| Voluntary Exercise | 33.4 score on Likert scale | 12.8 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 18.6 score on Likert scale | 18.7 (Standard Deviation) | 11 |
| Voluntary Exercise | 20.2 score on Likert scale | 7.5 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 14.0 score on Likert scale | 10.6 (Standard Deviation) | 11 |
| Voluntary Exercise | 18.7 score on Likert scale | 6.9 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 9.9 score on Likert scale | 10.3 (Standard Deviation) | 11 |
| Voluntary Exercise | 11.8 score on Likert scale | 3.6 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 7.6 score on Likert scale | 7.4 (Standard Deviation) | 11 |
| Voluntary Exercise | 12.3 score on Likert scale | 7.3 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 7.2 score on Likert scale | 6.9 (Standard Deviation) | 11 |
| Voluntary Exercise | 6.8 score on Likert scale | 6.6 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 2.0 score on Likert scale | 1.9 (Standard Deviation) | 11 |
| Voluntary Exercise | 2.3 score on Likert scale | 2.1 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 1.5 score on Likert scale | 1.7 (Standard Deviation) | 11 |
| Voluntary Exercise | 1.6 score on Likert scale | 1.7 (Standard Deviation) | 7 |
Multiple Sclerosis Manual Dexterity Test
Week 0 (baseline), Week 13 (post exercise sessions)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Forced Aerobic Exercise (FE) | 31.4 Time in Seconds | 8.2 (Standard Deviation) | 11 |
| Voluntary Exercise (VE) | 24.3 Time in Seconds | 4.1 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 32.4 Time in Seconds | 7.8 (Standard Deviation) | 11 |
| Voluntary Exercise (VE) | 23.9 Time in Seconds | 4.4 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 33.8 Time in Seconds | 5.8 (Standard Deviation) | 11 |
| Voluntary Exercise (VE) | 25.4 Time in Seconds | 2 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 35.4 Time in Seconds | 9.8 (Standard Deviation) | 11 |
| Voluntary Exercise (VE) | 39.6 Time in Seconds | 35.9 (Standard Deviation) | 7 |
Processing Speed Test
Week 0 (baseline), Week 13 (post exercise sessions)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Forced Aerobic Exercise (FE) | 43.0 number correct | 8 (Standard Deviation) | 10 |
| Voluntary Exercise | 55.3 number correct | 8.5 (Standard Deviation) | 7 |
| Forced Aerobic Exercise (FE) | 45.1 number correct | 9.4 (Standard Deviation) | 10 |
| Voluntary Exercise | 57.4 number correct | 9.8 (Standard Deviation) | 7 |
Forced Aerobic Exercise (FE)
Voluntary Exercise
Forced Aerobic Exercise (FE)
Voluntary Exercise
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Forced Aerobic Exercise (FE) | 12 | 1 (8.3%) | 0 |
| Voluntary Aerobic Exercise (VE) | 10 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Exercise Duration
collected during each exercise session (twice per week for 12 weeks)
Physical functionAerobic Intensity
Collected during each exercise session (twice per week for 12 weeks)
Physical functionExercise Cadence
collected during each exercise session (twice per week for 12 weeks)
Physical functionSix Minute Walk Test
Week 0 (baseline), Week 13 (post exercise sessions)
Walking and mobilityGait Velocity
Week 0 (baseline), Week 13 (post exercise sessions)
Walking and mobilityPROMIS-29
Week 0 (baseline), Week 13 (post exercise sessions)
FatiguePainMood and sleepQuality of life (reported by participants)Modified Fatigue Impact Scale (MFIS)
Week 0 (baseline), Week 13 (post exercise sessions)
Thinking and memoryFatigueMultiple Sclerosis Manual Dexterity Test
Week 0 (baseline), Week 13 (post exercise sessions)
Thinking and memoryArm and hand functionProcessing Speed Test
Week 0 (baseline), Week 13 (post exercise sessions)
Thinking and memory
Other measures (1)
To Investigate the Role of Klotho in Promoting Neuroprotection.
Week 1 (exercise session 1), Week 12 (exercise session 24)
Physical function
Who could take part
Relapsing MS · 18 to 75 · EDSS 1.5 to 6.5
Show the full criteria
Inclusion criteria
1. Confirmed diagnosis of RRMS with Expanded Disability Status Scale (EDSS) score between 1.5 and 6.5, 2. 18-75 years of age, 3. Deemed minimal risk for cardiovascular event using American College of Sports Medicine Exercise Pre-participation Criteria
Exclusion criteria
1. hospitalization for myocardial infarction, heart failure or heart surgery within 3 months, 2. serious cardiac arrhythmia, 3. hypertrophic cardiomyopathy, 4. severe aortic stenosis, 5. pulmonary embolus, 6. significant contractures, 7. dysphagia resulting in inability to sufficiently hydrate, and 8. other contraindication to exercise.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This project will investigate the feasibility and initial efficacy of two aerobic exercise training approaches, forced and voluntary, to improve motor function in persons with multiple sclerosis (MS). We hypothesize that intensive aerobic exercise training elicits a neurorepairative and neurorestorative response on the central nervous system, which may improve motor function as it relates to gait and mobility. Should aerobic cycling, forced or voluntary, improve gait and functional mobility in persons with MS, it would serve as a new model to restoring function, rather than current models that focus on compensation.
Papers
Loading reviews and guidelines…
History
Started
Jul 2021
Main results due
Nov 2022
Finished
Nov 2022
Results posted
Feb 2025