N/A
N=22
The Therapeutic Effects of Forced Aerobic Exercise in Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT04906057 ↗Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Feb 2025
Primary outcome: Primary: Exercise Duration — 42.2; 42.2 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Forced Aerobic Exercise (FE) (Behavioral); Voluntary Aerobic Exercise (VE) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Duration |
42.2; 42.2 | — |
| PRIMARY Aerobic Intensity |
0.63; .70 | — |
| PRIMARY Exercise Cadence |
69.1; 64.5 | — |
| PRIMARY Six Minute Walk Test |
339.1; 345.9; 338.3; 373.6 | — |
| PRIMARY Gait Velocity |
90.6; 91.5; 122.4; 131.0; 0.54; 0.65 | — |
| PRIMARY PROMIS-29 |
40.2; 40.8; 40.0; 40.0; 46.6; 49.5 | — |
| PRIMARY Modified Fatigue Impact Scale (MFIS) |
21.9; 33.4; 18.6; 20.2; 14.0; 18.7 | — |
| PRIMARY Multiple Sclerosis Manual Dexterity Test |
31.4; 24.3; 32.4; 23.9; 33.8; 25.4 | — |
| PRIMARY Processing Speed Test |
43.0; 55.3; 45.1; 57.4 | — |
| SECONDARY To Investigate the Role of Klotho in Promoting Neuroprotection. |
1273.3; 1100.4; 929.5; 1166.4; 948.3; 1019.4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of RRMS with Expanded Disability Status Scale (EDSS) score between 1.5 and 6.5,
- 18-75 years of age,
- Deemed minimal risk for cardiovascular event using American College of Sports Medicine Exercise Pre-participation Criteria
Exclusion Criteria
- hospitalization for myocardial infarction, heart failure or heart surgery within 3 months,
- serious cardiac arrhythmia,
- hypertrophic cardiomyopathy,
- severe aortic stenosis,
- pulmonary embolus,
- significant contractures,
- dysphagia resulting in inability to sufficiently hydrate, and
- other contraindication to exercise.
Data sourced from ClinicalTrials.gov (NCT04906057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.