Trial Summary
What is the purpose of this trial?This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS).
Is the ExerciseRx treatment a promising treatment for Multiple Sclerosis?Yes, ExerciseRx is a promising treatment for Multiple Sclerosis. Research shows that exercise can improve walking, cognitive performance, fatigue, depression, and overall quality of life for people with MS. It is generally safe and can lead to positive changes in daily life.12378
What safety data exists for exercise interventions in multiple sclerosis?Exercise interventions in multiple sclerosis have been systematically reviewed for safety. A review of 26 studies with 1295 participants found that exercise training did not increase the risk of relapse compared to control groups, with a relative risk of 0.73. The rate of adverse events was slightly higher in exercise groups (2.0%) compared to control groups (1.2%), but this risk was not higher than in healthy populations. Overall, exercise is considered safe and well-tolerated for individuals with multiple sclerosis.346710
What data supports the idea that Exercise Intervention for Multiple Sclerosis is an effective treatment?The available research shows that exercise can be a safe and effective way to improve various functions in people with Multiple Sclerosis (MS). For example, one study found that participants who trained for and completed a challenging expedition reported a significant reduction in fatigue. Another study highlighted that exercise and physical activity can positively impact brain function, walking ability, fatigue, depression, pain, and overall quality of life for people with MS. These findings suggest that exercise can help manage symptoms and improve daily life for those with MS.12589
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for adults over 18 with Multiple Sclerosis who can walk without help but are not very active (less than 150 minutes of exercise per week). They must have an iPhone or Android phone to use the study app and cannot be at high risk of falling or have other conditions that make exercising unsafe.Inclusion Criteria
I am 18 years old or older.
Treatment Details
The study tests a phone-based app called ExerciseRx designed to increase physical activity in people with MS. Participants will use this app, which aims to promote more movement through personalized guidance and tracking.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ExerciseRx-MSExperimental Treatment1 Intervention
Participants use the ExerciseRx app to meet personalized daily step targets and weekly goals. They will receive MS Exercise and Physical Activity Recommendations and complete in-app surveys about barriers to being active and physical activity level. The ExerciseRx app will adjust the personalized step count goals based on percentage met of the previous week goal and providers will send supportive messages based on participant activity. Participants will complete validated self-report assessments.
Providers may also provide participants with additional guidance, make referrals, or schedule telemedicine or in-person clinic follow ups if needed to support the participant's physical activity progression.
Group II: Usual careActive Control1 Intervention
Participants receive MS Exercise and Physical Activity Recommendations, will continue typical physical activity, and complete validated self-report assessments.
At the end of 26 weeks, staff will offer the participants the ExerciseRx intervention protocol.
Find a clinic near you
Research locations nearbySelect from list below to view details:
UW MedicineSeattle, WA
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Who is running the clinical trial?
University of WashingtonLead Sponsor
References
Physical Exercise and MS Recommendations. [2022]The use of physical exercise programmes in the rehabilitation of patients with multiple sclerosis (MS) has been a controversial issue for many years. During the last decade, however, evidence from a number of studies has suggested that exercise is a safe and efficient way to induce improvements in a number of physiological functions, which ultimately can lead to functional improvements that have a positive effect on a patients daily life. The purpose of this review is, based on the existing research, to provide clinicians with some easily administrable recommendations for the application of exercise in the rehabilitation strategy of MS.
The role of exercise in modifying outcomes for people with multiple sclerosis: a randomized trial. [2021]Despite the commonly known benefits of exercise and physical activity evidence shows that persons Multiple Sclerosis (MS) are relatively inactive yet physical activity may be even more important in a population facing functional deterioration. No exercise is effective if it is not done and people with MS face unique barriers to exercise engagement which need to be overcome. We have developed and pilot tested a Multiple Sclerosis Tailored Exercise Program (MSTEP) and it is ready to be tested against general guidelines for superiority and ultimately for its impact on MS relevant outcomes. The primary research question is to what extent does an MS Tailored Exercise Program (MSTEP) result in greater improvements in exercise capacity and related outcomes over a one year period in comparison to a program based on general guidelines for exercise among people with MS who are sedentary and wish to engage in exercise as part of MS self-management.
Exercise in multiple sclerosis. [2022]Exercise is an intervention that may be used in the management of multiple sclerosis (MS). Certain exercise physiology characteristics are commonly seen among persons with MS, particularly in the more debilitated. Studies have shown that properly prescribed exercise programs can improve modifiable impairments in MS. Exercise is generally safe and well tolerated. General guidelines are available for exercise prescription for the MS population. There are several recommendations that may help improve the quality of future MS exercise trials.
The safety of exercise training in multiple sclerosis: a systematic review. [2022]There are many reviews documenting the benefits of exercise training among persons with multiple sclerosis (MS). To date, we are unaware of a review that summarizes the risks of relapse and other adverse events (AEs) associated with exercise training, yet this is critical for informing decisions and recommendations regarding the safety of this behavior. We conducted a systematic review of relapse and other AEs reported in randomized controlled trials (RCTs) of exercise training in MS. We searched electronic databases for RCTs of exercise training in MS. We calculated the rate of relapse and AEs, and the relative risk of relapse and AEs for exercise training versus control. Twenty-six studies were reviewed that included 1295 participants. We determined that the rate of relapse was 6.3% and 4.6% for control and exercise, respectively. The rate of AEs was 1.2% and 2.0% for control and exercise, respectively. The relative risk of relapse for exercise training was 0.73, whereas the relative risk of AE for exercise training was 1.67. Exercise training was not associated with an increased risk of relapse, and risk of AEs was not higher than in healthy populations. This evidence should alleviate uncertainty regarding the safety of exercise training in MS.
Impact of a 5-day expedition to machu picchu on persons with multiple sclerosis. [2021]Persons with multiple sclerosis (MS) are less physically active than nondiseased persons and often report low self-efficacy levels. In the context of an awareness project to promote physical activity and participation in MS, we addressed the impact of training for and participation in a unique expedition. Medical events, relapses, and self-reported neurological worsening were followed from 6 months before and up to 4 months afterwards. Validated patient-reported outcome measures were used to assess fatigue, self-efficacy in exercising, walking abilities, and illness perception. Nine participants completed the training, expedition, and observational study. Minor events, relapses, and/or neurological worsening were reported in six participants. The three participants with mild disability and no cardiovascular risk factors or comorbidities were free of medical and neurological events. We found a significant reduction of motor fatigue at last when compared with the first assessment. The reduction tended to be more evident in participants with mild disability (Expanded Disability Status Scale (EDSS)
Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south. [2021]Long-term exercise/rehabilitation is an integral component of the continual care for people with multiple sclerosis (MS). However, access to this care, which includes comprehensive exercise/rehabilitation services to people with MS, remains a significant challenge, especially in rural, low-income areas. Telerehabilitation, or what we refer to as teleexercise, can help fill service gaps for underserved MS populations in this region. This pragmatic, cluster randomized controlled effectiveness trial will compare a 12-week, 20 session complementary and alternative medicine (CAM) intervention composed of neurorehabilitative (functional) exercise, yoga and Pilates delivered at home, using pre-loaded tablets and Interactive Voice Response (IVR) system technology (TeleCAM), to the same intervention delivered in clinic by a therapist (DirectCAM). Eight hundred and twenty people with MS are being recruited across Alabama, Mississippi and Tennessee. Primary self-reported patient-centered health outcomes are: pain, fatigue, quality of life and physical activity. Secondary outcomes include four physical functioning measures: balance, endurance, gait, and strength. Each of these outcomes will be examined by age, race, sex, severity of MS and other demographics to determine if outcomes are beneficial across all groups (i.e., heterogeneity of treatment effect). The project is important to people with MS and/or caregivers because it aims to reduce their barriers to receiving exercise treatment and increases the convenience and appeal of such programs through technology. Clinical Trials.gov Identifier: NCT03117881.
Exercise and Multiple Sclerosis. [2020]Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system (CNS) with an estimated prevalence approaching 1 million adults in the United States. The disease pathogenesis and resulting damage express as dysfunction (e.g., walking and cognitive impairment) and symptoms (e.g., fatigue and depression) that compromise quality of life (QOL) and full participation. There has been a steadily increasing body of research on the outcomes of exercise among persons with MS, and this has accelerated sharply over the past decade. The current chapter provides a review of exercise and its outcomes, safety, and prescription in MS. This chapter initially reviews the evidence for benefits of exercise based principally on meta-analyses and literature reviews. The chapter then reviews evidence on the safety of exercise in MS and lastly provides guidelines for exercise prescription in MS. Collectively, this chapter serves as an overview and reference for researchers and clinicians interested in the benefits, safety, and prescription of exercise in MS.
Lessons learned from clinical trials of exercise and physical activity in people with MS - guidance for improving the quality of future research. [2022]The body of research on exercise and physical activity among persons with multiple sclerosis(MS) has expanded rapidly in quantity, but not necessarily quality, over the past 20+ years. There is evidence for beneficial effects of exercise and physical activity on immune cells and neurotrophic factors, brain structure and function, walking and cognitive performance, fatigue, depression, and pain, and quality of life among persons with MS. Nevertheless, there is heterogeneity in the outcomes of exercise and physical activity, and a recognition of substantial challenges for improving the effectiveness of those behaviors in MS. To move the field forward, members of the National MS Society physical wellness research working-group pooled collective experiences for identifying challenges, logistic complexities, and opportunities for researchers in designing and conducting interventions of exercise and physical activity among persons with MS. We examined the scope of our experiences and identified collective "lessons learned" regarding the behaviors themselves; study design features and stage of research; study setting, safety, and sample selection; and implementation of randomized controlled trials(RCTs) and treatment fidelity. This paper provides a resource that can inform researchers, particularly new investigators or established investigators transitioning into MS, on conducting high-quality RCTs on exercise and physical activity in MS.
The MoxFo initiative - outcomes: Outcome measures in studies of exercise training in multiple sclerosis; scoping review of reviews and classification according to the ICF framework. [2023]The number of published studies of exercise training in multiple sclerosis (MS) has grown exponentially with increasing numbers of outcomes capturing exercise effects. This has complicated the selection of relevant indicators and interpretation of intervention effects.
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.