Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis
- Conditions
- Multiple SclerosisMajor Depressive Disorder
- Interventions
- Behavioral: FLEX-MSBehavioral: POWER-MS
- Registration Number
- NCT05051618
- Lead Sponsor
- University of Illinois at Chicago
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 146
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FLEX-MS FLEX-MS 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. POWER-MS POWER-MS 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.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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) Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
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) Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate worse quality of life.
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) Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS). The BICAMS includes Symbol Digit Modalities Test (SDMT), first five learning trials of the California Verbal Learning Test-II (CVLT-II), and first three learning trials of the Brief Visuospatial Memory Test-Revised (BVMT-R).
SDMT scores range between 0 (min) and 110 (max), higher scores indicate better performance.
CVLT-II scores range between 0 (min) and 80 (max), higher scores indicate better performance.
BVMT-R scores range between 0 (min) and 36 (max), higher scores indicate better performance.
Trial Locations
- Locations (1)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States