Exercise Training for Depression in Multiple Sclerosis

(METS in MS Trial)

Overseen By Robert W Motl, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Severe mental illness, Ambulatory disability, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to examine the effects of two different exercise training regimens for managing depression and improving other health indicators among persons with multiple sclerosis (MS). The project will enroll persons with MS and major depressive disorder (MDD) between 18 and 64 years of age. The investigators will enroll a total of 146 participants. This is a Phase-II trial that compares the efficacy of an exercise training program (POWER-MS) compared with a stretching program (FLEX-MS) for immediate and sustained reductions in the severity of depression among persons with MS who have MDD.

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.

Is exercise training safe for people with multiple sclerosis?

Exercise training is generally considered safe for people with multiple sclerosis, and it is commonly recommended for managing the condition in clinical practice. ^{1 2 3 4 5}

How does the treatment FLEX-MS, POWER-MS differ from other treatments for depression in multiple sclerosis?

FLEX-MS and POWER-MS are unique because they focus on exercise training, which has been shown to improve depressive symptoms, fatigue, and quality of life in people with multiple sclerosis, unlike conventional therapies that often under-treat these symptoms. This approach is particularly beneficial as it is physically accessible and can be tailored to individuals with varying levels of mobility. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment FLEX-MS, Stretching Program, FLEX-MS, POWER-MS, Exercise Training Program, POWER-MS Exercise Regimen for depression in multiple sclerosis?

Research shows that exercise training can help reduce depressive symptoms in people with multiple sclerosis. Studies have found that exercise improves mood, reduces fatigue, and enhances quality of life in MS patients, suggesting that similar exercise programs like FLEX-MS and POWER-MS could be beneficial. ^{2 4 5 6 7}

Who Is on the Research Team?

Robert Motl, Ph.D

Principal Investigator

University of Illinois Chicago

Are You a Good Fit for This Trial?

This trial is for people aged 18-64 with Multiple Sclerosis (MS) and Major Depressive Disorder (MDD), who have internet access, speak English, and are willing to participate in exercise testing. They must not have had a relapse or taken steroids recently, should be relatively inactive based on specific questionnaires, and cannot have certain severe mental illnesses.

Inclusion Criteria

Have you had a relapse in the last 30 days?

Do you exercise 3 times a week or more?

Have you ever been diagnosed with depression or had episodes of depression in your past?

Exclusion Criteria

Do you have a heart condition or bone and joint issue that would prevent you from exercising on a regular basis?

Are you able to walk without the use of a cane, walker, or wheelchair most of the time?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either the POWER-MS or FLEX-MS exercise program to manage depression and improve health indicators

16 weeks

Remote coaching sessions

Immediate Follow-up

Assessment of exercise behavior, quality of life, physical activity, muscle strength, aerobic capacity, cognitive performance, depression severity, and fatigue severity

4 weeks

In-person and virtual assessments

Long-term Follow-up

Continued monitoring of exercise behavior, quality of life, physical activity, muscle strength, aerobic capacity, cognitive performance, depression severity, and fatigue severity

16 weeks

In-person and virtual assessments

What Are the Treatments Tested in This Trial?

Interventions

• FLEX-MS
• POWER-MS

Trial Overview The study compares two exercise programs for reducing depression in MS patients: POWER-MS (an exercise training program) versus FLEX-MS (a stretching program). It aims to see which one better decreases the severity of depression immediately and over time.

How Is the Trial Designed?

Group I: POWER-MS Experimental Treatment 1 Intervention

The POWER-MS condition will deliver the Guidelines for Exercise in MS (GEMS) program with a remotely coached/guided, home-based setting using telerehabilitation. GEMS recommends 30 minutes of moderate intensity aerobic activity, 3x/week AND strength training exercises for major muscle groups, 3x/week.

Group II: FLEX-MS Active Control 1 Intervention

The FLEX-MS condition will primarily focus on flexibility as the applicable exercise modality. As such, the program will emphasize that flexibility is an important component of fitness. The goal would be for each participant to enhance their flexibility by engaging in a titrated exercise prescription where the number of sets and time to hold per set will increase throughout the 16-week program.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Published Research Related to This Trial

Maximal strength training (MST) significantly reduced perceived fatigue by nearly 60% and improved functional mobility in people with multiple sclerosis (pwMS) over an 8-week period, indicating its efficacy as a therapeutic intervention.

However, the benefits of MST diminished after a 10-week detraining period, highlighting the need for ongoing training to maintain improvements in strength and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Maximal Strength Training on Perceived-Fatigue and Functional Mobility in Persons with Relapsing-Remitting Multiple Sclerosis. Gomez-Illan, R., Reina, R., Barbado, D., et al.[2021]

A meta-analysis of 13 randomized controlled trials involving exercise training showed a small but statistically significant improvement in depressive symptoms among people with multiple sclerosis, with an effect size of 0.36.

This suggests that incorporating exercise training can be a beneficial intervention for reducing depression in individuals with MS, despite the overall effect being modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training improves depressive symptoms in people with multiple sclerosis: results of a meta-analysis. Ensari, I., Motl, RW., Pilutti, LA.[2022]

In a 12-week randomized controlled trial involving 31 moderately disabled multiple sclerosis patients, progressive resistance training significantly reduced fatigue and improved mood and quality of life compared to a control group.

The positive effects on fatigue, mood, and quality of life were not only significant during the training but were also maintained for at least 12 weeks after the intervention ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue, mood and quality of life improve in MS patients after progressive resistance training. Dalgas, U., Stenager, E., Jakobsen, J., et al.[2022]

An eight-week progressive resistance training program significantly improved lower extremity strength in multiple sclerosis (MS) patients, with notable increases in knee extension (7.4%) and plantarflexion strength (52%).

Participants also experienced improved walking performance (8.7% increase in stepping) and a reduction in self-reported fatigue, indicating that resistance training can enhance mobility and decrease fatigue in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training improves strength and functional capacity in persons with multiple sclerosis. White, LJ., McCoy, SC., Castellano, V., 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]

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 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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Maximal Strength Training on Perceived-Fatigue and Functional Mobility in Persons with Relapsing-Remitting Multiple Sclerosis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Exercise training improves depressive symptoms in people with multiple sclerosis: results of a meta-analysis. [2022]

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

Fatigue, mood and quality of life improve in MS patients after progressive resistance training. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Resistance training improves strength and functional capacity in persons with multiple sclerosis. [2022]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Safety of exercise training in multiple sclerosis: An updated systematic review and meta-analysis. [2023]

7. Netherlands 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. [2022]