100 Participants Needed

Exercise Training Program for Multiple Sclerosis

(TEAAMS Trial)

EF
Robert Motl, Ph.D profile photo
Overseen ByRobert Motl, Ph.D
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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.12345

Is 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.46789

How 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.123410

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).

Research Team

Motl, Robert | College of Applied ...

Robert Motl, Ph.D

Principal Investigator

University of Illinois at Chicago

Eligibility 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)
See 6 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

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

Treatment Details

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.
Participant Groups
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

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 profile image

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 profile image

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+

Findings from Research

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.
Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis.Adamson, BC., Learmonth, YC., Kinnett-Hopkins, D., et al.[2017]
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.
Current perspectives on exercise training in the management of multiple sclerosis.Motl, RW., Sandroff, BM.[2021]
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.
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]

References

Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis. [2017]
Current perspectives on exercise training in the management of multiple sclerosis. [2021]
Do internet resources align with exercise training and physical activity guidelines for people with multiple sclerosis? [2022]
Physical exercise in multiple sclerosis: supportive care or a putative disease-modifying treatment. [2022]
Benefits of Exercise Training in Multiple Sclerosis. [2022]
Safety of exercise training in multiple sclerosis: An updated systematic review and meta-analysis. [2023]
Exercise in multiple sclerosis. [2022]
The safety of exercise training in multiple sclerosis: a systematic review. [2022]
Benefits, safety, and prescription of exercise in persons with multiple sclerosis. [2022]
The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. [2022]
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