146 Participants Needed

Exercise Training for Depression in Multiple Sclerosis

(METS in MS Trial)

RW
Overseen ByRobert W Motl, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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. It's best to discuss this with the trial coordinators or your doctor.

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.12345

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.12567

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.23457

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.

Research Team

Motl, Robert | College of Applied ...

Robert Motl, Ph.D

Principal Investigator

University of Illinois Chicago

Eligibility Criteria

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?
See 1 more

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: POWER-MSExperimental Treatment1 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-MSActive Control1 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.

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

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials
59
Recruited
10,600+

Findings from Research

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

References

Effects of Maximal Strength Training on Perceived-Fatigue and Functional Mobility in Persons with Relapsing-Remitting Multiple Sclerosis. [2021]
Exercise training improves depressive symptoms in people with multiple sclerosis: results of a meta-analysis. [2022]
Fatigue, mood and quality of life improve in MS patients after progressive resistance training. [2022]
Resistance training improves strength and functional capacity in persons with multiple sclerosis. [2022]
Current perspectives on exercise training in the management of multiple sclerosis. [2021]
Safety of exercise training in multiple sclerosis: An updated systematic review and meta-analysis. [2023]
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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