Exercise Training for Depression in Multiple Sclerosis
(METS in MS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Chicago
Disqualifiers: Severe mental illness, Ambulatory disability, others
No Placebo Group
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment FLEX-MS, Stretching Program, FLEX-MS, POWER-MS, Exercise Training Program, POWER-MS Exercise Regimen for depression in multiple sclerosis?
Research shows that exercise training can help reduce depressive symptoms in people with multiple sclerosis. Studies have found that exercise improves mood, reduces fatigue, and enhances quality of life in MS patients, suggesting that similar exercise programs like FLEX-MS and POWER-MS could be beneficial.
12345Is exercise training safe for people with multiple sclerosis?
Exercise training is generally considered safe for people with multiple sclerosis, and it is commonly recommended for managing the condition in clinical practice.
12567How does the treatment FLEX-MS, POWER-MS differ from other treatments for depression in multiple sclerosis?
FLEX-MS and POWER-MS are unique because they focus on exercise training, which has been shown to improve depressive symptoms, fatigue, and quality of life in people with multiple sclerosis, unlike conventional therapies that often under-treat these symptoms. This approach is particularly beneficial as it is physically accessible and can be tailored to individuals with varying levels of mobility.
23457Eligibility Criteria
This trial is for people aged 18-64 with Multiple Sclerosis (MS) and Major Depressive Disorder (MDD), who have internet access, speak English, and are willing to participate in exercise testing. They must not have had a relapse or taken steroids recently, should be relatively inactive based on specific questionnaires, and cannot have certain severe mental illnesses.Inclusion Criteria
Have you had a relapse in the last 30 days?
Do you exercise 3 times a week or more?
Have you ever been diagnosed with depression or had episodes of depression in your past?
+1 more
Exclusion Criteria
Do you have a heart condition or bone and joint issue that would prevent you from exercising on a regular basis?
Are you able to walk without the use of a cane, walker, or wheelchair most of the time?
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage in either the POWER-MS or FLEX-MS exercise program to manage depression and improve health indicators
16 weeks
Remote coaching sessions
Immediate Follow-up
Assessment of exercise behavior, quality of life, physical activity, muscle strength, aerobic capacity, cognitive performance, depression severity, and fatigue severity
4 weeks
In-person and virtual assessments
Long-term Follow-up
Continued monitoring of exercise behavior, quality of life, physical activity, muscle strength, aerobic capacity, cognitive performance, depression severity, and fatigue severity
16 weeks
In-person and virtual assessments
Participant Groups
The study compares two exercise programs for reducing depression in MS patients: POWER-MS (an exercise training program) versus FLEX-MS (a stretching program). It aims to see which one better decreases the severity of depression immediately and over time.
2Treatment groups
Experimental Treatment
Active Control
Group I: POWER-MSExperimental Treatment1 Intervention
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.
Group II: FLEX-MSActive Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Illinois at ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
University of Alabama at BirminghamLead Sponsor
Congressionally Directed Medical Research ProgramsCollaborator
References
Effects of Maximal Strength Training on Perceived-Fatigue and Functional Mobility in Persons with Relapsing-Remitting Multiple Sclerosis. [2021]Background and objectives: Fatigue is one of the most disabling symptoms that limit daily life activities in persons with multiple sclerosis (pwMS). This study aimed to evaluate the effects of maximal strength training (MST) on perceived-fatigue and functional mobility in pwMS. Materials and Methods: 26 participants with MS were balanced according to their pre-intervention fatigue scores and distributed into an MST group (n = 13) and a control group (CG; n = 13). The MST group completed eight weeks using high loads, evaluating detraining after ten weeks. Quadriceps and hamstring isokinetic (QPTIK; HPTIK) and isometric (QPTIM; HPTIM) peak torques were assessed using an isokinetic dynamometer. Effect size differences were estimated with the Hedges' g index (dg ). Fatigue was evaluated through the Fatigue Severity Scale (FSS), while functional mobility was assessed via the Timed Up and Go Test (TUG). Results: The MST significantly improved all the strength measurements after the intervention (Δ6.43-29.55%; p < 0.05) compared to the control group. FSS showed a significant reduction (59.97%, dg = 5.41, large). The MST group also reduced the TUG time (19.69%; dg = 0.93, large) compared to the control group. Improvements caused by the intervention did not remain after a 10-week follow-up, with decreases in strength performance from 4.40% to 13.86% (dg = 0.24-0.56, small to moderate), 112.08% in the FSS (dg = -3.88, large), and 16.93% in TUG (dg = -1.07, large). Conclusions: MST (up to 90% 1RM) seems to be a feasible and useful way to obtain clinically relevant improvements in the perceived-fatigue symptoms and functional mobility. Still, symptom improvements decrease after a 10-week detraining period.
Exercise training improves depressive symptoms in people with multiple sclerosis: results of a meta-analysis. [2022]There is a high prevalence, yet under-treatment of depressive disorder and symptoms by conventional therapy in people with multiple sclerosis (MS). We conducted a meta-analysis examining the overall effect of exercise training on depressive symptoms in MS.
Fatigue, mood and quality of life improve in MS patients after progressive resistance training. [2022]Fatigue occurs in the majority of multiple sclerosis patients and therapeutic possibilities are few. Fatigue, mood and quality of life were studied in patients with multiple sclerosis following progressive resistance training leading to improvement of muscular strength and functional capacity. Fatigue (Fatigue Severity Scale, FSS), mood (Major Depression Inventory, MDI) and quality of life (physical and mental component scores, PCS and MCS, of SF36) were scored at start, end and follow-up of a randomized controlled clinical trial of 12 weeks of progressive resistance training in moderately disabled (Expanded Disability Status Scale, EDSS: 3-5.5) multiple sclerosis patients including a Control group (n = 15) and an Exercise group (n = 16). Fatigue (FSS > 4) was present in all patients. Scores of FSS, MDI, PCS-SF36 and MCS-SF36 were comparable at start of study in the two groups. Fatigue improved during exercise by -0.6 (95% confidence interval (CI) -1.4 to 0.4) a.u. vs. 0.1 (95% CI -0.4 to 0.6) a.u. in controls (p = 0.04), mood improved by -2.4 (95% CI -4.1 to 0.7) a.u. vs. 1.1 (-1.2 to 3.4) a.u. in controls (p = 0.01) and quality of life (PCS-SF36) improved by 3.5 (95% CI 1.4-5.7) a.u. vs. -1.0 (95% CI -3.4-1.4) a.u. in controls (p = 0.01). The beneficial effect of progressive resistance training on all scores was maintained at follow-up after further 12 weeks. Fatigue, mood and quality of life all improved following progressive resistance training, the beneficial effect being maintained for at least 12 weeks after end of intervention.
Resistance training improves strength and functional capacity in persons with multiple sclerosis. [2022]The purpose of this study was to evaluate the effect of an eight-week progressive resistance training programme on lower extremity strength, ambulatory function, fatigue and self-reported disability in multiple sclerosis (MS) patients (mean disability score 3.7 +/- 0.8). Eight MS subjects volunteered for twice weekly training sessions. During the first two weeks, subjects completed one set of 8-10 reps at 50% of maximal voluntary contraction (MVC) of knee flexion, knee extension and plantarflexion exercises. In subsequent sessions, the subjects completed one set of 10-15 repetitions at 70% of MVC. The resistance was increased by 2-5% when subjects completed 15 repetitions in consecutive sessions. Isometric strength of the quadriceps, hamstring, plantarflexor and dorsiflexor muscle groups was assessed before and after the training programme using an isokinetic dynamometer. Magnetic resonance images of the thigh were acquired before and after the exercise programme as were walking speed (25-ft), number of steps in 3 min, and self-reported fatigue and disability. Knee extension (7.4%), plantarflexion (52%) and stepping performance (8.7%) increased significantly (P
Current perspectives on exercise training in the management of multiple sclerosis. [2021]The science supporting the application of exercise training and physical activity in persons with multiple sclerosis (MS) has expanded considerably in strength and scope over the past 25+ years. Exercise training is now a strategy that is commonly recommended for management of MS in clinical practice. Yet, there are still many opportunities for expanding the breadth and strength of research on exercise training in MS.
Safety of exercise training in multiple sclerosis: An updated systematic review and meta-analysis. [2023]A review of the safety profile of exercise training in multiple sclerosis (MS) has not been conducted since 2013.
The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. [2022]There is evidence for the benefits of exercise training in persons with multiple sclerosis (MS). However, these benefits have primarily been established in individuals with mild-to-moderate disability (i.e., Expanded Disability Status Scale [EDSS] scores 1.0-5.5), rather than among those with significant mobility impairment. Further, the approaches to exercise training that have been effective in persons with mild-to-moderate MS disability may not be physically accessible for individuals with mobility limitations. Therefore, there is a demand for an evidence-base on the benefits of physically accessible exercise training approaches for managing disability in people with MS with mobility impairment.