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Exercise Training for Managing Depression in Multiple Sclerosis

This study is looking at how two different exercise programs, POWER-MS and FLEX-MS, can help people with multiple sclerosis (MS) who also experience major depressive disorder (MDD). POWER-MS involves aerobic (like walking) and resistance exercises, while FLEX-MS focuses on stretching. Researchers want to see if these programs can reduce depression and improve other health measures. They plan to enroll 146 participants, aged 18 to 64, who have both MS and MDD. The main goal is to see how much depression severity changes, both immediately after the 16-week program and 8 months later.

Study design
This is a Phase II interventional study comparing two exercise programs. It plans to enroll 146 participants.
What's involved
You would complete testing and questionnaires, wear an accelerometer, and be willing to be randomly assigned to one of the exercise programs. The interventions last 16 weeks, with follow-up at 8 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 8 months after the 16-week intervention to assess long-term changes in depression severity.

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NCT05051618

Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis

Recruiting
NAAges 18–64InterventionalTreatment
University of Illinois at Chicago
~146 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:POWER-MSFLEX-MS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Depression Severity (self-report)
Measured over baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)
+1 more outcome measured

Conditions

Multiple Sclerosis
Major Depressive Disorder

Explore related trials

Multiple SclerosisUnipolar Depression

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Robert W Motl, PhD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

Who to contact

Robert W Motl, PhD
[email protected]
205-975-1306
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Physical confirmed diagnosis of Multiple Sclerosis (MS)
Diagnosis of Major Depressive Disorder (MDD) - see below (MINI)
English as primary language
Eligible age (between 18 and 64 years old)
Relapse and steroid free in past 30 days
Internet and email access
Willingness to complete the testing and questionnaires, wear the accelerometer, undergo randomization, and engage in exercise testing

Exclusion

Godin Leisure Time Exercise Questionnaire (GLTEQ): Exclude if health contribution score of 14 units or more. This assessment is administered to confirm insufficient baseline physical activity (i.e., not meeting current PA guidelines)
Patient Determined Disease Steps (PDDS): Exclude if score above '2' (i.e., greater than mild ambulatory disability). This assessment is administered as the proposed intervention focuses on walking as main modality for exercise training. The scale asks the participant to describe their walking situation on a scale of 0 to 8; where lower scores indicate better walking ability.
Beck Depression Inventory-Fast Screen (BDI-FS): Exclude if a score less than '4'. The scale measures depression and those with a score of '4' or below likely have very mild depression resulting in floor effects and/or spontaneous remission.
Physical Activity Readiness Questionnaire (PAR-Q): Exclude if more than one yes/affirmative response on this 7-item self-report assessment. This assessment is administered to exclude those individuals who are at a moderate to high risk for contraindications of injury or possible death when undertaking strenuous or maximal exercise. This is a 7-item self-report tool where more than one yes/affirmative response indicates that an individual is not recommended to engage in physical activity within the capacity of this study. Those scoring more than one yes/affirmative response will be further advised to seek medical guidance before becoming more physically active.
Telephone Interview for Cognitive Status (TICS-M): Exclude if scores less than 18. This assessment is administered to ensure that all participants can adequately follow directions. The application of the TICS-M is to ensure that participants do not have severe cognitive impairment that might preclude the ability to adhere to the conditions, understand intervention content, and interact with behavior coaches.
MINI International Neuropsychiatric Interview (version 7.0.2) based on the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V): Include those who meet the criteria for MDD, but exclude for other severe mental illness (obsessive-compulsive disorder, schizophrenia, bipolar or other psychotic disorders) as indicated by the MINI; these persons would require more intensive mental health treatment.

What this trial measures

  • Change in Depression Severity (self-report)baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)

    Patient Health Questionnaire (PHQ-9); scores range between 0 (min) and 27 (max), higher scores indicate greater depression severity.

  • Change in Depression Severity (observer-rated)baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)

    Hamilton Depression Rating Scale (HDRS-17); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of depressive symptoms.