University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Location status: Recruiting
NCT Number: NCT05051618
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.
Interested in participating?
Request Info18 year–64 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 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.
The 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).
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)
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)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
University of Illinois at Chicago
Other
Acronym: METS in MS
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