Exercise Rehabilitation for Multiple Sclerosis

(MSGH Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Enrico Benedetti, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Illinois at Chicago

Disqualifiers: No MS, Under 18, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Approximately 50% of people with multiple sclerosis (MS) use a wheelchair within 30 years of the initial diagnosis. Wheelchair use in MS is often associated with fatigue as a consequence of muscle weakness. Indeed, fatigue, a prevalent consequence of MS, often becomes debilitating and exhausts energetic resources when carrying-out tasks of daily life and/or interacting with the community, as these require ambulatory mobility. This experience of excessive fatigue has its roots in muscle weakness and results in reliance on a wheelchair for mobility, and the dependency on a wheelchair may further reduce muscular strength, particularly of the lower extremities. We propose that wheelchair users with MS can increase muscular strength through a personalized exercise rehabilitation, and this in turn will improve ambulatory performance and possibly reduce fatigue. To date, no research has examined the effects of this specific exercise rehabilitation program (GH method) on physical function and other disease-related outcomes in persons with MS who use wheelchairs as a primary mobility device.

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 data supports the effectiveness of the treatment Exercise Rehabilitation Program, Exercise Rehabilitation Program, GH method for multiple sclerosis?

Research shows that exercise programs can improve muscle strength, walking capacity, and quality of life for people with multiple sclerosis, making exercise a recommended part of managing the condition. ^{1 2 3 4 5}

Is exercise rehabilitation generally safe for humans?

Exercise rehabilitation is generally safe for humans, as studies show that medically supervised exercise programs have low rates of serious complications, even in high-risk groups like cardiac patients. However, it's important to have medical clearance and supervision, especially for those with existing health conditions. ^{6 7 8 9 10}

How is the Exercise Rehabilitation Program treatment different from other treatments for multiple sclerosis?

The Exercise Rehabilitation Program for multiple sclerosis is unique because it focuses on improving physical functions through structured exercise, which can enhance daily life activities. Unlike traditional drug treatments, this program uses physical activity to safely improve muscle strength, mobility, and overall quality of life. ^{1 2 3 4 11}

Research Team

Enrico Benedetti, MD

Principal Investigator

University of Illinois Chicago

Eligibility Criteria

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 have been diagnosed with multiple sclerosis (MS).

I am over 18 years old.

I am considered low risk for physical activity complications.

Trial Timeline

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

Treatment Details

Interventions

• Exercise Rehabilitation Program (Behavioural Intervention)

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.

Participant Groups

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+

Mark I. Rosenblatt

University of Illinois at Chicago

Chief Executive Officer

MD, PhD, MBA, MHA

Jon Radosta

University of Illinois at Chicago

Chief Medical Officer since 2023

MD

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2012]

2. Italy 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. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Physical Exercise and MS Recommendations. [2022]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Current perspectives on exercise training in the management of multiple sclerosis. [2021]

6. United States 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. [2015]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of high-intensity exercise on cardiorespiratory fitness in stroke survivors: A systematic review and meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. [2022]

9. United States 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. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. England 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]. [2023]