Tele-Exercise and Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of two delivery models of an
      evidence-based complementary alternative medicine (CAM) program that combines
      neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with
      multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different
      delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM).
      Participants will be randomly assigned to one of these two groups.

      **On March 16th, 2020, the University of Alabama at Birmingham halted all onsite
      non-essential research in response to the Covid-19 pandemic. Since then, the study has begun
      to conduct all testing remotely through videoconferencing technology. In addition, another
      study group, remote DirectCAM (rDirectCAM), has been incorporated into the study to continue
      the 12-week program delivery for newly recruited participants via videoconferencing
      technology.**
    

Detailed description: 
      There are few primary care and multiple sclerosis (MS) clinics that provide full exercise and
      rehabilitation services for patients with MS, especially in mostly rural, low-income areas
      such as Alabama, Mississippi, and Tennessee. Telerehabilitation, or the delivery of
      rehabilitation services over the telephone and/or the Internet, can help fill service gaps
      for underserved MS patient populations in this region. The proposed study will determine if
      our evidence-based rehabilitation and exercise program produces similar health outcomes when
      delivered in clinic or at home, using pre-loaded tablets and Interactive Voice Response (IVR)
      system technology among 759 participants with MS from 40 clinics across Alabama, Mississippi,
      and Tennessee.

      **In response to the Covid-19 pandemic, the study aims to recruit 74 participants with MS
      into the rDirectCAM, where the 12-week program is delivered in real-time via
      videoconferencing technology. The rDirectCAM will determine if a telehealth rehabilitation
      program can have a similar effect as when the program is offered in person.**

      The outcomes that we hope to achieve through the proposed rehabilitation and exercise
      program, referred to as complementary alternative medicine, are improved physical activity,
      decreased pain and fatigue, and quality of life. We also seek to improve attitudes and
      behaviors related to physical activity, such as outcome expectations for physical activity,
      social support from family and friends for physical activity, self-eﬃcacy (i.e., confidence
      in one's ability to be active), and self-regulation (i.e., setting exercise goals). We will
      examine the variation in outcomes by patient characteristics such as age and severity of
      disability to determine for whom the intervention is effective.

      This project is important to patients with MS because it seeks to reduce their barriers to
      receiving exercise treatment and increase the convenience and appeal of such programs through
      technology. Furthermore, findings and resources from this study will be quickly provided to
      MS patients and clinicians across the United States (e.g., via training webinars through our
      National Center on Health, Physical Activity, and Disability [NCHPAD]) and thereby improve
      the quality and reach of exercise treatment for patients with MS.

      The patient and stakeholder partners include MS patients, caretakers, and clinicians, who
      have been actively guiding the development of this project. In stakeholder meetings, members
      have provided insight into exercise treatment needs and preferences (e.g., individually
      tailored approaches that account for varying levels of mobility); outcomes of interest to the
      patient population (e.g., pain, fatigue, quality of life); and strategies for
      engaging/motivating participants with MS who may be discouraged and experiencing fatigue and
      pain (e.g., IVR calls and feedback). Moreover, their ongoing program satisfaction feedback
      will be important to our recruitment and retention success. Finally, the stakeholders will
      help make this project successful by continuing to emphasize the importance of long-term
      gains in health outcomes and promote (through NCHPAD) the sustainability of the program.
    

Intervention name(s): DirectCAM; TeleCAM; rDirectCAM
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.; The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.; The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Multiple Sclerosis; Yoga; Pilates; Telerehabilitation; Physical activity