Exercise Rehabilitation for Multiple Sclerosis

(MSGH Trial)

Overseen By Ilaria Santi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: No MS, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 48

Duration: 6 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an exercise rehabilitation program for people with multiple sclerosis (MS) who use a wheelchair. The researchers aim to determine if personalized muscle therapy can boost strength and reduce fatigue, potentially improving walking ability and reducing tiredness. Participants will either join a six-month exercise program or be part of a control group with the option to try the exercises later. The trial suits those with MS who use a wheelchair but can still walk at least 50 feet with some assistance. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance the quality of life for those with MS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise rehabilitation program is safe for people with multiple sclerosis?

Research has shown that exercise programs for people with multiple sclerosis (MS) are generally safe. Studies have found that exercising does not increase the risk of relapses or serious side effects compared to inactivity. Participants in exercise programs reported them as safe and beneficial, experiencing no harmful effects.

In this study, the exercise program is expected to be well-tolerated. It includes personalized muscle therapy sessions designed to improve strength and reduce fatigue. Although this specific program has not been tested before, existing evidence suggests that exercise can be a safe option for people with MS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for multiple sclerosis (MS) focus on managing symptoms with medications like disease-modifying therapies or corticosteroids. Researchers are excited about the exercise rehabilitation program because it offers a non-drug approach, personalizing muscle therapy to help improve mobility and strength. Unlike standard MS treatments, which often don't address physical function directly, this program involves one-on-one sessions tailored to each participant, potentially providing a more targeted way to enhance daily living and physical capabilities over time.

What evidence suggests that this exercise rehabilitation program is effective for multiple sclerosis?

Research has shown that personalized exercise programs can greatly benefit people with multiple sclerosis (MS). Studies have found that supervised exercise routines improve fitness, daily functioning, and overall quality of life for those with MS. One study discovered that a 13-week virtual group exercise program was safe, effective, and well-liked by participants. In this trial, participants in the exercise rehabilitation program arm will engage in a personalized, one-hour, one-on-one muscle therapy session, two days a week, for 6 months. Exercise programs, whether done at home or in a clinic, have shown promising results in improving balance and overall health. These findings suggest that structured exercise could help those with MS who use wheelchairs, potentially boosting muscle strength and reducing tiredness. ^{2 6 7 8 9}

Who Is on the Research Team?

Enrico Benedetti, MD

Principal Investigator

University of Illinois Chicago

Are You a Good Fit for This Trial?

This trial is for adults over 18 with MS who primarily use wheelchairs. They must be able to walk at least 50 feet with an assistive device, have had no MS relapses in the last month, and show low risk for exercise contraindications per the PAR-Q.

Inclusion Criteria

I am considered low risk for physical activity complications.

I have been diagnosed with multiple sclerosis (MS).

I am over 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will take part in a personalized, one-hour, one-on-one muscle therapy session, two days a week, for 6 months

6 months

48 visits (in-person)

Follow-up

Participants are monitored for changes in physical function, self-reported health-related outcomes, and cognitive function

4 weeks

Open-label extension (optional)

Participants in the control group have the option to complete the exercise rehabilitation intervention once the study reaches completion

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Rehabilitation Program

Trial Overview

The study tests a personalized exercise rehabilitation program (GH method) designed to increase muscular strength in wheelchair users with MS, aiming to improve their mobility and reduce fatigue.

How Is the Trial Designed?

Group I: Exercise rehabilitation program Experimental Treatment 1 Intervention

• Participants will take part in a personalized, one-hour, one-on-one muscle therapy session, two days a week, for 6 months.

Group II: Control Active Control 1 Intervention

• Participants will complete the study measures on three separate occasions and will have the option to complete the exercise rehabilitation intervention once the study reaches completion.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

Recent studies indicate that physical exercise programs are safe and effective for improving various physiological functions in patients with multiple sclerosis (MS).

Implementing exercise in rehabilitation strategies can lead to functional improvements that positively impact the daily lives of MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Exercise and MS Recommendations. Dalgas, U., Ingemann-Hansen, T., Stenager, E.[2022]

In a study of 13,570 cardiac rehabilitation participants across 30 programs, there were 50 cardiac arrests during exercise, with a high resuscitation success rate of 84%, indicating that supervised exercise can be performed safely for selected cardiac patients.

The overall complication rates were low, with one nonfatal event occurring every 34,673 patient hours and one fatal event every 116,402 patient hours, suggesting that continuous ECG monitoring during exercise further enhances safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular complications during exercise training of cardiac patients. Haskell, WL.[2019]

The study evaluated the feasibility of multimodal agility-based exercise training (MAT) for people with multiple sclerosis (pwMS) and found that both MAT and traditional strength and endurance training (SET) were feasible in an inpatient setting, with participants completing the required number of sessions.

While both groups showed similar short-term reductions in fatigue and improvements in motor function, MAT participants demonstrated a significant improvement in walking endurance, exceeding the minimal important change, suggesting potential benefits of MAT for pwMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal agility-based exercise training (MAT) versus strength and endurance training (SET) to improve multiple sclerosis-related fatigue and fatigability during inpatient rehabilitation: a randomized controlled pilot and feasibility study [ReFEx]. Wolf, F., Nielsen, J., Saliger, J., et al.[2023]

A 3-week exercise program using a whole body vibration platform significantly improved muscle strength in patients with multiple sclerosis, particularly in the quadriceps and hamstrings, compared to a control group.

While the exercise program enhanced muscle strength, it did not lead to significant improvements in functional mobility, as measured by balance and walking tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 3 weeks' whole body vibration training on muscle strength and functional mobility in hospitalized persons with multiple sclerosis. Claerbout, M., Gebara, B., Ilsbroukx, S., et al.[2012]

An 8-week aerobic training program significantly improved walking distances, speeds, and maximum exercise tolerance in 11 subjects with mild to moderate multiple sclerosis, compared to neurological rehabilitation.

Aerobic training was particularly beneficial for individuals with greater disability, enhancing their peak oxygen uptake and maximum work rate, although it did not show a significant impact on fatigue or overall health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic training on walking capacity and maximal exercise tolerance in patients with multiple sclerosis: a randomized crossover controlled study. Rampello, A., Franceschini, M., Piepoli, M., et al.[2022]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

A systematic review of 773 studies involving over 38,000 participants found that exercise therapy does not increase the risk of serious adverse events, indicating it is a safe intervention.

However, exercise therapy was associated with a higher risk of non-serious adverse events, with a relative risk of 1.19, meaning that for every 6 participants, one additional non-serious adverse event may occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Niemeijer, A., Lund, H., Stafne, SN., et al.[2022]

High-intensity exercise significantly improves cardiorespiratory fitness in stroke survivors, as evidenced by increased peak oxygen uptake (VO2peak) and performance on the 6-minute walk test, based on a meta-analysis of 17 studies involving various exercise protocols.

The study found no significant difference in adverse events between high-intensity exercise and control groups, suggesting that this type of exercise may be a safe intervention for stroke survivors in cardiopulmonary rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of high-intensity exercise on cardiorespiratory fitness in stroke survivors: A systematic review and meta-analysis. Luo, L., Meng, H., Wang, Z., et al.[2022]

In a study of 1,147 patients, administering regadenoson during recovery from inadequate exercise was found to be non-inferior to administering it after exercise, meaning both methods were equally effective in detecting reversible perfusion defects.

The safety profile of regadenoson during recovery was favorable, with fewer adverse events reported compared to administration after exercise, suggesting it can be a safe option when monitored properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The EXERRT trial: "EXErcise to Regadenoson in Recovery Trial": A phase 3b, open-label, parallel group, randomized, multicenter study to assess regadenoson administration following an inadequate exercise stress test as compared to regadenoson without exercise for myocardial perfusion imaging using a SPECT protocol. Thomas, GS., Cullom, SJ., Kitt, TM., et al.[2018]

The MS-Fit neurorehabilitation program for people with multiple sclerosis demonstrated high feasibility and adherence, with 89% of the 55 participants completing the two-month training, achieving an average attendance rate of 92%.

Participants reported high satisfaction with the program, scoring a median of 9 out of 10 on a satisfaction scale, indicating that the structured, supervised training effectively improved their quality of life and ability to perform daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized, comprehensive, hospital-based circuit training in people with multiple sclerosis: results on feasibility, adherence and satisfaction of the training intervention. Lehmann, I., Thaler, I., Luder, G., et al.[2020]

Exercise training is now widely recommended for managing multiple sclerosis (MS), reflecting over 25 years of research supporting its benefits for individuals with the condition.

The paper highlights eight emerging research areas, such as behavior change interventions and telerehabilitation, that could enhance the effectiveness and implementation of exercise in clinical practice for MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current perspectives on exercise training in the management of multiple sclerosis. Motl, RW., Sandroff, BM.[2021]

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