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Exercise Training for Depression in Multiple Sclerosis (METS in MS Trial)

Verified Trial

N/A

Recruiting

Led By Robert W Motl, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Have you had a relapse in the last 30 days?

Must not have

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 3 weeks

Treatment Varies

Follow Up baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of different exercise training regimens on depression symptoms and other health indicators in people with MS & MDD.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial primarily involves physical activity regimens that typically do not cause severe side effects, participants may experience muscle soreness or fatigue related to increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Depression Severity (observer-rated)

Change in Depression Severity (self-report)

Secondary study objectives

Change in Cognitive Performance

Change in Perception of Fatigue Severity

Change in Quality of Life

Other study objectives

Change in Aerobic Capacity

Change in Muscle Strength

Change in Physical Activity

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met