Exercise Training Program for Multiple Sclerosis

(TEAAMS Trial)

Overseen By Robert Motl, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: High exercise risk, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new exercise program designed to help African-Americans with multiple sclerosis (MS) improve walking, symptoms, and overall quality of life. It compares a home-based exercise routine, known as the Guidelines for Exercise in Multiple Sclerosis (GEMS), with the FLEX Stretching and Toning Program to determine which is more effective over four months. African-Americans diagnosed with MS, living in rural areas, and struggling to maintain an exercise routine may find this trial suitable. Participants will use the internet to follow and report on their exercise activities. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance exercise programs for individuals 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.

What prior data suggests that this exercise training program is safe for individuals with multiple sclerosis?

Research shows that exercise is safe for people with multiple sclerosis (MS). Studies have found no increased risk of relapses or serious side effects compared to other activities. Exercise programs, such as the Guidelines for Exercise in Multiple Sclerosis (GEMS), recommend 30 minutes of aerobic exercise twice a week, along with strength training. People with MS generally tolerate these activities well, and they may improve health in various ways. Therefore, this treatment appears safe for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Guidelines for Exercise in Multiple Sclerosis (GEMS) because it introduces a structured, home-based exercise program specifically tailored for individuals with MS, unlike typical pharmacological treatments like interferons or glatiramer acetate. This program emphasizes aerobic and resistance exercise, which may improve physical fitness and overall quality of life for people with MS without the side effects associated with medications. The GEMS approach is unique because it provides remote support and guidance, making it accessible and convenient for participants to integrate into their daily lives. By focusing on exercise as a core component, this method may offer a complementary alternative to traditional MS treatments, potentially enhancing mobility and function.

What evidence suggests that this exercise program is effective for improving walking dysfunction in multiple sclerosis?

Research shows that exercise can help people with Multiple Sclerosis (MS). Studies have found that regular aerobic and strength training can improve walking, lift mood, and boost overall health. In this trial, participants will follow different exercise programs. The Guidelines for Exercise in Multiple Sclerosis (GEMS) is one such program, recommending at least 30 minutes of moderate aerobic exercise twice a week, along with strength exercises, to help manage MS symptoms. Evidence also suggests that exercise can benefit brain function and immune health in people with MS. Overall, exercise programs like GEMS may improve the quality of life for those with MS. ^{2 3 5 6 7}

Who Is on the Research Team?

Robert Motl, Ph.D

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for African-American adults with Multiple Sclerosis living in rural areas, who are not very active physically, can use the internet and email, speak English, have been relapse-free for 30 days, and have mild to moderate walking difficulties. It's not for those at high risk of injury or death from intense exercise.

Inclusion Criteria

I am willing to fill out the study questionnaires.

I have been diagnosed with multiple sclerosis (MS).

Insufficient physical activity (not meeting current physical activity guidelines based on GLTEQ)

Exclusion Criteria

Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ)

Individuals not meeting above inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-month home-based, remotely supported exercise or stretching program

16 weeks

Remote support throughout the program

Follow-up

Participants are monitored for sustained improvements in walking dysfunction, symptoms, and HRQOL

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FLEX Stretching and Toning Program
• Guidelines for Exercise in Multiple Sclerosis (GEMS)

Trial Overview

The study tests a remote exercise program tailored for African-Americans with MS against a control group doing stretching exercises. The goal is to see if the program improves walking ability, symptoms, and quality of life immediately and over four months.

How Is the Trial Designed?

Group I: Guidelines for Exercise in Multiple Sclerosis (GEMS) Experimental Treatment 1 Intervention

Participants in this condition will receive a 4-month home-based, remotely supported aerobic and resistance exercise program based on the Guidelines for Exercise in Multiple Sclerosis (GEMS).

Group II: FLEX Stretching and Toning Program Placebo Group 1 Intervention

Participants in this condition will receive a 4-month home-based, remotely supported stretching program emphasizing flexibility and range of motion as important components of fitness based on Stretching for People with MS: An Illustrated Manual from the National MS Society.

Guidelines for Exercise in Multiple Sclerosis (GEMS) is already approved in United States for the following indications:

Approved in United States as GEMS Exercise Program for:

• Multiple Sclerosis

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Bristol-Myers Squibb Foundation

Collaborator

Trials

6

Recruited

1,300+

Published Research Related to This Trial

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]

Exercise is an effective behavioral approach for improving function and managing symptoms in individuals with multiple sclerosis (MS), supported by literature reviews and meta-analyses.

The review emphasizes that exercise is generally safe for people with MS, with low reports of relapses and adverse events, and provides guidelines for safe exercise practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits, safety, and prescription of exercise in persons with multiple sclerosis. Motl, RW.[2022]

The GEMS program is a randomized controlled trial designed to evaluate the feasibility and efficacy of a 4-month home-based exercise program for adults with mild-to-moderate multiple sclerosis, focusing on improving symptoms and health-related quality of life.

Participants will engage in aerobic and resistance training, supported by exercise equipment and regular communication with specialists, with the goal of informing future larger trials on the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis. Adamson, BC., Learmonth, YC., Kinnett-Hopkins, D., et al.[2017]

Recent studies indicate that exercise training can provide significant benefits for individuals with multiple sclerosis (MS), improving fitness, quality of life, and potentially reducing disability.

The review highlights the possible biological mechanisms behind these benefits, such as the role of neurotrophic factors and anti-inflammatory cytokines, suggesting that exercise may have neuroprotective effects in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise in multiple sclerosis: supportive care or a putative disease-modifying treatment. Heesen, C., Romberg, A., Gold, S., et al.[2022]

A study evaluated 157 webpages about physical activity for people with multiple sclerosis (MS) and found that only 27 met the criteria for quality information, with most pages addressing only 5 out of 18 established physical activity guidelines.

The most frequently covered guidelines included identifying MS-specific symptoms and providing examples of aerobic and strength training, indicating a gap in comprehensive adherence to the recommended physical activity guidelines for individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do internet resources align with exercise training and physical activity guidelines for people with multiple sclerosis? Sadeghi-Bahmani, D., Silveira, SL., Baird, JF., et al.[2022]

A systematic review of 40 randomized controlled trials involving 1780 participants found that exercise training does not increase the risk of clinical relapse or adverse events in individuals with multiple sclerosis, suggesting it is a safe intervention.

The analysis showed no significant differences in the rates of relapse, adverse events, or serious adverse events between exercise training and non-exercise groups, supporting the promotion of exercise as a beneficial activity for people with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of exercise training in multiple sclerosis: An updated systematic review and meta-analysis. Learmonth, YC., P Herring, M., Russell, DI., et al.[2023]

A systematic review of 26 randomized controlled trials involving 1295 participants found that exercise training in individuals with multiple sclerosis (MS) did not increase the risk of relapse, with a relapse rate of 4.6% for exercise compared to 6.3% for control.

The study also reported that the rate of adverse events (AEs) was similar between exercise (2.0%) and control (1.2%) groups, indicating that exercise training is generally safe and does not pose a higher risk of AEs compared to healthy populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of exercise training in multiple sclerosis: a systematic review. Pilutti, LA., Platta, ME., Motl, RW., et al.[2022]

A systematic review of 19 studies found that exercise training, particularly adapted modalities like body-weight support treadmill training and electrical stimulation cycling, can lead to significant improvements in mobility, physical fitness, and quality of life for individuals with severe mobility impairment due to multiple sclerosis (MS).

While conventional exercise training showed some benefits, the majority of positive outcomes were associated with adapted exercise approaches, highlighting the need for accessible exercise interventions for people with MS who have high levels of disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. Edwards, T., Pilutti, LA.[2022]

Exercise training can lead to small but significant improvements in various aspects of life for people with multiple sclerosis (MS), including walking, balance, cognition, fatigue, depression, and overall quality of life.

The review emphasizes the importance of promoting exercise as a key component of clinical care for MS patients, suggesting that healthcare providers, especially neurologists, should actively encourage exercise training based on recent guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Exercise Training in Multiple Sclerosis. Motl, RW., Sandroff, BM.[2022]

Exercise is a safe and well-tolerated intervention that can effectively improve modifiable impairments in individuals with multiple sclerosis (MS).

Properly prescribed exercise programs, following general guidelines, can enhance the management of MS, particularly for those with more severe symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in multiple sclerosis. Sandoval, AE.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26655434/

Feasibility study design and methods for Project GEMS

The Guidelines for Exercise in Multiple Sclerosis (GEMS) program is a randomized controlled trial (RCT) examining the feasibility and efficacy of a home-based ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714415301336

Feasibility study design and methods for Project GEMS

These guidelines specify that persons with MS should engage in a minimum of 30 min of aerobic exercise 2 days per week and resistance training exercises to ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT02297932

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To date, the evidence suggests that exercise intervention in MS holds anywhere from minimal to great promise depending on the outcome of interest. For some ...

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archives-pmr.org

archives-pmr.org/article/s0003-9993(13)00425-5/fulltext

Development of Evidence-Informed Physical Activity ...

The resulting guidelines state that adults with MS should engage in at least 30 minutes of moderate intensity aerobic activity 2 times per week and strength ...

5.

msard-journal.com

msard-journal.com/article/S2211-0348(22)00596-X/fulltext

Lessons learned from clinical trials of exercise and ...

There is evidence for beneficial effects of exercise and physical activity on immune cells and neurotrophic factors, brain structure and function, walking and ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2211034825003657

Exercise Training in Multiple Sclerosis: Preparing for ...

Exercise training is safe and highly beneficial for people with multiple sclerosis (MS). •. Physical inactivity and sedentary behavior remain particularly ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10637110/

Safety of exercise training in multiple sclerosis - PubMed Central

In studies that reported safety outcomes, there was no higher risk of relapse, AE, adverse effects or SAE for exercise training than the comparator.