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Clinical Trials/NCT05051618
NCT05051618
Recruiting
Not Applicable

Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis

University of Illinois at Chicago1 site in 1 country146 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Illinois at Chicago
Enrollment
146
Locations
1
Primary Endpoint
Change in Depression Severity (observer-rated)
Status
Recruiting
Last Updated
10 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
March 31, 2026
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert W Motl

Professor

University of Illinois at Chicago

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Depression Severity (observer-rated)

Time Frame: 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.

Change in Depression Severity (self-report)

Time Frame: 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.

Secondary Outcomes

  • Change in Quality of Life(baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months))
  • Change in Perception of Fatigue Severity(baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months))
  • Change in Cognitive Performance(baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months))

Study Sites (1)

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