Exercise Training for Older Adults With Multiple Sclerosis

Overseen By Peixuan Zheng, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Neurological conditions, Cardiovascular diseases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a 16-week exercise program can enhance thinking skills and physical abilities in older adults with multiple sclerosis (MS). Participants will engage in either an aerobic and resistance exercise program (GEMS program) or a flexibility and stretching program (FLEX-MS program), both conducted from home with online support. The trial seeks individuals who have MS, are 50 or older, and experience some difficulty with thinking and walking. The study aims to demonstrate that regular exercise can provide lasting benefits in mental and physical health for those with MS. As an unphased trial, it offers participants the chance to contribute to valuable research that could improve 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's best to discuss this with the trial coordinators or your doctor.

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

Research shows that exercise, such as running, cycling, and strength training, is generally safe for people with multiple sclerosis (MS). Studies have found that these activities do not increase the risk of symptom flare-ups or cause serious issues. In fact, they often enhance fitness and overall health without major side effects.

Research indicates that flexibility and stretching exercises are also safe and do not lead to more flare-ups or serious problems compared to other exercises. These programs improve movement and flexibility, which are important for people with MS.

In summary, existing research considers both exercise programs under study safe and well-tolerated for people with MS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise programs for older adults with multiple sclerosis (MS) because they offer a non-pharmaceutical approach to managing the condition. Unlike standard treatments that often focus on medications to control symptoms, these programs emphasize physical activity, which can enhance overall fitness and potentially improve mobility and flexibility. The GEMS program combines aerobic and resistance exercises, providing comprehensive physical benefits, while the FLEX-MS program focuses on flexibility and stretching, crucial for maintaining range of motion. These home-based, remotely supported interventions make it easier for participants to integrate exercise into their daily routines, which could lead to better adherence and outcomes.

What evidence suggests that this trial's treatments could be effective for older adults with multiple sclerosis?

Research has shown that exercise programs can benefit people with multiple sclerosis (MS). In this trial, participants will join one of two programs. The Aerobic and Resistance Exercise Program, known as the GEMS program, has improved walking, balance, and overall quality of life for those with MS. Studies indicate that combining aerobic and resistance exercises can significantly boost physical fitness and muscle strength.

In contrast, the Flexibility and Stretching Program (FLEX-MS) may improve leg flexibility, helping with muscle stiffness and preventing painful muscle cramps. Both programs can enhance physical abilities in older adults with MS, but the GEMS program focuses more on building strength and endurance. ^{1 2 3 5 6}

Who Is on the Research Team?

Peixuan Zheng, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults aged 50 or older with Multiple Sclerosis who can walk (with or without help) and have mild-to-moderate cognitive impairment. They must have internet access, be able to visit the lab for tests, and not have had an MS relapse in the last month. People with other neurological conditions, cardiovascular diseases, or a high risk of injury from exercise cannot join.

Inclusion Criteria

I have been diagnosed with multiple sclerosis (MS).

Mild-to-moderate cognitive impairment (TICS-M; MSNQ)

I can travel to the lab for tests.

Exclusion Criteria

Individuals not meeting above inclusion criteria

I have been diagnosed with a neurological or cardiovascular condition.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 16-week remotely-delivered exercise training intervention, including aerobic and resistance exercises, or a flexibility and stretching program.

16 weeks

Remote sessions supported by Zoom-based chats

Follow-up

Participants are monitored for sustained effects on cognition, mobility, and physical activity after the intervention.

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic and Resistance Exercise Program (GEMS program)
• Flexibility and Stretching Program (FLEX-MS program)

Trial Overview The study is testing if a home-based exercise program combining aerobic and resistance training can improve thinking skills and mobility in older adults with MS compared to a flexibility/stretching program. The exercises are done over Zoom calls with coaches for 16 weeks, followed by another 16 weeks to see if benefits last.

How Is the Trial Designed?

Group I: Aerobic and Resistance Exercise Program (GEMS program) Experimental Treatment 1 Intervention

This intervention condition will deliver the Guidelines for Exercise in Multiple Sclerosis (GEMS) program. Participants in this condition will receive a 16-week home-based, remotely supported aerobic and resistance exercise training intervention.

Group II: Flexibility and Stretching Program (FLEX-MS program) Active Control 1 Intervention

Participants in this condition will receive a 16-week 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Citations

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

Feasibility study design and methods for Project GEMS Participants in the intervention will receive a 4-month home-based exercise program emphasizing aerobic and resistance training. Participants ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S221103482300250X

Effects of aerobic, resistance, and combined exercise ... Exercise training is clinically effective for improving overall HRQOL in MS and produces greater improvements in the physical domain of HRQOL than the mental ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11541987/

Advancements and Challenges in Exercise Training for ... The comprehensive review of evidence from RCTs indicates that exercise training yields substantial improvements in aerobic and muscle fitness, ...

4. withpower.com withpower.com/trial/phase-sclerosis-8-2022-eb67c

Exercise Training Program for Multiple Sclerosis The GEMS program, which includes aerobic and resistance training, is designed to improve these outcomes by following MS-specific physical activity guidelines.

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

Feasibility study design and methods for Project GEMS There is evidence that exercise training can improve walking mobility [4], balance [5], coordination [6], fatigue [7], depression [8], and HRQOL [6] in persons ...

6. 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 ...