Multiple SclerosisMETS in MSNCT05051618
Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis
A study testing POWER-MS and FLEX-MS in people with Multiple Sclerosis and Major Depressive Disorder, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis, Major Depressive Disorder
- What is being tested?
- POWER-MS and FLEX-MS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
- Relapse and steroid free in past 30 days
- Internet and email access
- Willingness to complete the testing and questionnaires, wear the accelerometer, undergo randomization, and engage in exercise testing
Who cannot join
- 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.
- Telephone Interview for Cognitive Status (TICS-M): Exclude if scores less than 18. This assessment is administered to ensure that all participants can adequately follow directions. The application of the TICS-M is to ensure that participants do not have severe cognitive impairment that might preclude the ability to adhere to the conditions, understand intervention content, and interact with behavior coaches.
- MINI International Neuropsychiatric Interview (version 7.0.2) based on the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V): Include those who meet the criteria for MDD, but exclude for other severe mental illness (obsessive-compulsive disorder, schizophrenia, bipolar or other psychotic disorders) as indicated by the MINI; these persons would require more intensive mental health treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Robert W Motl, PhD, 3124137850, robmotl@uic.edu
About this study
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.
- Conditions
- Multiple Sclerosis, Major Depressive Disorder
- Being tested
- POWER-MS, FLEX-MS
- Keywords
- Multiple Sclerosis, MS, Depression, MDD, Exercise, Physical Activity, Intervention, Behavior
- Medical subject headings
- Multiple Sclerosis, Depressive Disorder, Major, Depression, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWER-MSBehavioural
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.
FLEX-MSBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: POWER-MS |
| 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. Receives: Behavioral: FLEX-MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)
Secondary outcomes (3)
Change in Perception of Fatigue Severity
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
Measured: 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
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.
Measured: 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.
Measured: baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Apr 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Robert W Motl, University of Illinois Chicago
- Investigators
- Robert W Motl, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051618
- Sponsor's protocol ID
- 2022-1354
- Other IDs
- W81XWH2110952
- Acronym
- METS in MS
- Status last verified
- Jun 2026
- First submitted
- 2 Sep 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38632556
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05051618
- Acronym / sponsor ID
- METS in MS / 2022-1354
- Conditions
- Multiple Sclerosis, Major Depressive Disorder
- Keywords
- Multiple Sclerosis, MS, Depression, MDD, Exercise, Physical Activity, Intervention, Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POWER-MS | Experimental | Behavioral: POWER-MSThe 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. |
| FLEX-MS | Active comparator | Behavioral: FLEX-MSThe 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
- Relapse and steroid free in past 30 days
Key exclusion criteria (6 listed)
- 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.
- Telephone Interview for Cognitive Status (TICS-M): Exclude if scores less than 18. This assessment is administered to ensure that all participants can adequately follow directions. The application of the TICS-M is to ensure that participants do not have severe cognitive impairment that might preclude the ability to adhere to the conditions, understand intervention content, and interact with behavior coaches.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POWER-MSThe 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. | Behavioural | POWER-MS |
| FLEX-MSThe 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). | Behavioural | FLEX-MS |
Primary outcome
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.
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.
3 secondary outcomes
Change in Perception of 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)
Change in Cognitive Performance
Time frame: 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
Time frame: baseline (week 0), immediate follow-up (week 16 or 4 months), and long-term follow-up (week 32 or 8 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 38632556Motl 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert W Motl, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWER-MS and FLEX-MS in people with Multiple Sclerosis and Major Depressive Disorder, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert W Motl, PhD (205-975-1306, robmotl@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05051618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.