Exercise Training Program for Multiple Sclerosis
(TEAAMS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Chicago
Disqualifiers: High exercise risk, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The proposed project involves a high-quality randomized controlled (RCT) design that examines the effects of a remotely-delivered, racially-tailored exercise training program for immediate and sustained improvement in walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with MS residing in rural environments. The primary analysis will test the hypothesis that those who are randomly assigned into the intervention condition (i.e., exercise training) will demonstrate (a) improvements in outcomes from baseline that (b) are sustained over 4-months of follow-up compared with those in the control condition (i.e., stretching).
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 data supports the effectiveness of the treatment FLEX Stretching and Toning Program, Exercise Training Program, and Guidelines for Exercise in Multiple Sclerosis (GEMS) for multiple sclerosis?
Research shows that exercise training can improve symptoms and quality of life for people with multiple sclerosis, with benefits in areas like walking, balance, and fatigue. The GEMS program, which includes aerobic and resistance training, is designed to improve these outcomes by following MS-specific physical activity guidelines.
12345Is exercise training safe for people with multiple sclerosis?
Exercise training is generally safe for people with multiple sclerosis. Studies show that it does not increase the risk of relapses (worsening of symptoms) and the risk of other adverse events (unwanted effects) is similar to that in healthy people.
46789How is the GEMS Exercise Program different from other treatments for multiple sclerosis?
The GEMS Exercise Program is unique because it is a home-based exercise training program specifically designed for people with multiple sclerosis, focusing on aerobic and resistance training. It includes personalized support through video chats with an exercise specialist and behavior change strategies, which are not typically part of standard MS treatments.
123410Eligibility Criteria
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)
+7 more
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
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Guidelines for Exercise in Multiple Sclerosis (GEMS)Experimental Treatment1 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 ProgramPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Illinois at ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
University of Alabama at BirminghamCollaborator
Bristol-Myers SquibbIndustry Sponsor
Bristol-Myers Squibb FoundationCollaborator
References
Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis. [2017]The Guidelines for Exercise in Multiple Sclerosis (GEMS) program is a randomized controlled trial (RCT) examining the feasibility and efficacy of a home-based exercise training program based on recent physical activity guidelines and principles of behavior change for improving symptoms and health-related quality of life (HRQOL) in adults with multiple sclerosis (MS). The primary aim is to assess program feasibility in the four domains of process (e.g., recruitment, retention, and adherence), resources (e.g., communication, staff requirements, and monetary costs), management (e.g., time and accuracy in data collection/entry, and reporting of adverse events) and scientific outcomes (e.g., safety, burden, participant feedback and efficacy/outcomes). The trial will recruit individuals with mild-to-moderate MS-related disability across the United States who will be randomized into intervention or waitlist control conditions. All participants will complete home-based assessments (including wearing an accelerometer for 7 days and completion of a questionnaire booklet) prior to and upon completion of the 4-month program. Participants in the intervention will receive a 4-month home-based exercise program emphasizing aerobic and resistance training. Participants will be provided with exercise equipment, a DVD, a manual and a log-book. The exercise program will be supplemented with periodic newsletters in the mail highlighting principles of behavior change, and video-chats with an exercise specialist to provide motivation and social accountability. This trial serves to inform development of Phase II and III RCTs which can determine the actual efficacy and effectiveness of home-based exercise based on the MS-specific physical activity guidelines for improving symptoms and HRQOL.
Current perspectives on exercise training in the management of multiple sclerosis. [2021]The science supporting the application of exercise training and physical activity in persons with multiple sclerosis (MS) has expanded considerably in strength and scope over the past 25+ years. Exercise training is now a strategy that is commonly recommended for management of MS in clinical practice. Yet, there are still many opportunities for expanding the breadth and strength of research on exercise training in MS.
Do internet resources align with exercise training and physical activity guidelines for people with multiple sclerosis? [2022]Exercise training and lifestyle physical activity have been identified as evidence-based approaches for improving symptoms and quality of life among persons with multiple sclerosis (MS). Such evidence supported the development of physical activity guidelines (PAGs) for people with MS. The goal of such guidelines involved broad dissemination and uptake, as there is substantial evidence for low rates of participation in exercise training and physical activity in this population.
Physical exercise in multiple sclerosis: supportive care or a putative disease-modifying treatment. [2022]Multiple sclerosis (MS) is a neuroinflammatory and neurodegenerative disease affecting young adults and leading to considerable disability. For many years, patients have been advised to avoid physical activity. Today, however, an increasing number of studies have shown beneficial effects of exercise training in MS. It has been reported that such programs not only improve fitness parameters but can also enhance quality of life and beneficially affect some suggestive disability measures. Pilot studies even indicate a neuroprotective potential. This review summarizes the findings of the major clinical trials on exercise in MS. Possible biological effect mediators, such as neurotrophic factors or anti-inflammatory cytokines, will be discussed. Exercise management guidelines will be proposed and possible further research strategies are presented.
Benefits of Exercise Training in Multiple Sclerosis. [2022]Exercise training represents a behavioral approach for safely managing many of the functional, symptomatic, and quality of life consequences of multiple sclerosis (MS). This topical review paper summarizes evidence from literature reviews and meta-analyses, supplemented by recent individual studies, indicating that exercise training can yield small but important improvements in walking, balance, cognition, fatigue, depression, and quality of life in MS. The paper highlights limitations of research on exercise training and its consequences and future research directions and provides an overview for promotion of exercise training in MS based on recent prescriptive guidelines. Collectively, the evidence for the benefits of exercise training in MS suggests that the time is ripe for the promotion of exercise by healthcare providers, particularly neurologists as a central part of the clinical care and management of MS patients.
Safety of exercise training in multiple sclerosis: An updated systematic review and meta-analysis. [2023]A review of the safety profile of exercise training in multiple sclerosis (MS) has not been conducted since 2013.
Exercise in multiple sclerosis. [2022]Exercise is an intervention that may be used in the management of multiple sclerosis (MS). Certain exercise physiology characteristics are commonly seen among persons with MS, particularly in the more debilitated. Studies have shown that properly prescribed exercise programs can improve modifiable impairments in MS. Exercise is generally safe and well tolerated. General guidelines are available for exercise prescription for the MS population. There are several recommendations that may help improve the quality of future MS exercise trials.
The safety of exercise training in multiple sclerosis: a systematic review. [2022]There are many reviews documenting the benefits of exercise training among persons with multiple sclerosis (MS). To date, we are unaware of a review that summarizes the risks of relapse and other adverse events (AEs) associated with exercise training, yet this is critical for informing decisions and recommendations regarding the safety of this behavior. We conducted a systematic review of relapse and other AEs reported in randomized controlled trials (RCTs) of exercise training in MS. We searched electronic databases for RCTs of exercise training in MS. We calculated the rate of relapse and AEs, and the relative risk of relapse and AEs for exercise training versus control. Twenty-six studies were reviewed that included 1295 participants. We determined that the rate of relapse was 6.3% and 4.6% for control and exercise, respectively. The rate of AEs was 1.2% and 2.0% for control and exercise, respectively. The relative risk of relapse for exercise training was 0.73, whereas the relative risk of AE for exercise training was 1.67. Exercise training was not associated with an increased risk of relapse, and risk of AEs was not higher than in healthy populations. This evidence should alleviate uncertainty regarding the safety of exercise training in MS.
Benefits, safety, and prescription of exercise in persons with multiple sclerosis. [2022]Exercise represents a behavioral approach for the restoration of function and management of symptoms among persons with multiple sclerosis (MS). The current paper provides a review on the topic of exercise in MS and is separated into four sections. The first section defines exercise and related constructs. The second section summarizes evidence for the benefits of exercise in MS based on literature reviews and meta-analyses. The third section focuses on the safety of exercise in MS based on the reporting of relapses and other adverse events, and the last section describes guidelines for exercise. The paper concludes with a discussion of major limitations with the existing body of research and highlights some of the pressing areas for future research on exercise in MS.
The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. [2022]There is evidence for the benefits of exercise training in persons with multiple sclerosis (MS). However, these benefits have primarily been established in individuals with mild-to-moderate disability (i.e., Expanded Disability Status Scale [EDSS] scores 1.0-5.5), rather than among those with significant mobility impairment. Further, the approaches to exercise training that have been effective in persons with mild-to-moderate MS disability may not be physically accessible for individuals with mobility limitations. Therefore, there is a demand for an evidence-base on the benefits of physically accessible exercise training approaches for managing disability in people with MS with mobility impairment.