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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH2110952 | Other Grant/Funding Number | US Department of Defense |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POWER-MS | Experimental | 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. |
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| FLEX-MS | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POWER-MS | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months) |
| 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. | baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perception of Fatigue Severity | Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months) |
| Change in Physical Activity |
Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert W Motl, PhD | Contact | 205-975-1306 | robmotl@uic.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert W Motl, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38632556 | Derived | Motl RW, Bombardier CH, Duffecy J, Hibner B, Wathen A, Carrithers M, Cutter G. Study protocol: exercise training for treating major depressive disorder in multiple sclerosis. BMC Neurol. 2024 Apr 17;24(1):131. doi: 10.1186/s12883-024-03634-y. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D009043 | Motor Activity |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| FLEX-MS | Behavioral | 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). |
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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. |
| baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months) |
| 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. | 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. |
| baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months) |
| 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. | baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months) |
| 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. | baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |