Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Illinois at Chicago
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
POWER-MS
BehavioralThe POWER-MS intervention includes both aerobic exercise and resistance exercise: Aerobic Exercise: The goal of the aerobic exercise training is for participants to achieve three moderate-intensity walking sessions of 30+ minutes per session by the end of the 16-week intervention. Resistance Exercise: Participants will complete resistance exercise training that consists of 1-2 sets (10-15 repetitions) of 5-10 exercises targeting the lower body, upper body, and core muscle groups performed three days per week, with the sets, repetitions and number of exercises increasing based on an individualized difficulty level.
FLEX-MS
BehavioralThe FLEX-MS intervention is specifically a stretching exercise prescription. All exercise movements are consistent throughout the program. At the beginning of the program, the stretching exercise sessions will take five minutes (1 set) three days per week (15 minutes per week). By the end of the 16-week program, the sessions will take about 30 minutes (2 sets) to be performed three days per week (1.5 hours per week).
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: POWER-MSExperimental treatment 1 intervention
Group B: FLEX-MSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Depression Severity (self-report)
Patient Health Questionnaire (PHQ-9); scores range between 0 (min) and 27 (max), higher scores indicate greater depression severity.
Time frame
baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)2
Change in Depression Severity (observer-rated)
Hamilton Depression Rating Scale (HDRS-17); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of depressive symptoms.
Time frame
baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)Secondary outcomes
1
Change in Perception of Fatigue Severity
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
Time frame
baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)2
Change in Cognitive Performance
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.
Time frame
baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)3
Change in Quality of Life
Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate worse quality of life.
Time frame
baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)Other outcomes
1
Change in Self-Reported Exercise Behavior
Godin Leisure Time Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores reflect greater levels of physical activity.
Time frame
baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)2
Change in Physical Activity
Accelerometer measured moderate to vigorous physical activity (MVPA) over a seven-day period; scores range between 0 (min) and 1440 (max), higher scores indicate greater physical activity.
Time frame
baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)3
Change in Aerobic Capacity
Aerobic fitness measured as peak oxygen consumption using an incremental exercise test; scores range from 3.5 (min) with no upward bound, higher scores indicate better aerobic fitness.
Time frame
baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)4
Change in Muscle Strength
Bilateral isometric knee extensor (KE) and flexor (KF) peak torque will be measured using an isokinetic dynamometer; scores range from 0 (min) with no upward bound, higher scores indicate better muscle strength.
Time frame
baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov