Comparative Effectiveness Study Telerehab Versus Conventional

Comparative Effectiveness Study of an Exercise Intervention Delivered Via Telerehabilitation and Conventional Mode of Delivery

University of Alabama at Birmingham, University of North Carolina, Chapel Hill, University of Georgia, The Cleveland Clinic, University of Colorado, Denver, Marquette University, Accelerated Cure Project for Multiple Sclerosis, Patient-Centered Outcomes Research Institute, Tanner Foundation for Multiple Sclerosis, Massachusetts General Hospital

This study aims to compare the effectiveness of an exercise program delivered in a conventional facility-based format versus a telerehabilitation format, which takes place in the home. Exercise can improve mobility and perhaps decrease the rate and extent of disability in people with MS. Evidence shows that traditional, facility-based exercise training may help people with MS consistently participate in exercise or to exercise at a higher, more intense level. Despite this evidence, lack of access to facility-based exercise programs may make it difficult for people with MS to engage in exercise.Telerehabilitation (telerehab) has great potential to overcome challenges associated with facility-based programs. Telerehab can include videoconferencing, remote monitoring of signs and activity, and dissemination of specialized and individualized information via electronic mechanisms, such as smartphones and computers. Both facility-based and telerehab exercise training have yielded positive results in people with MS, but have not been compared head-to-head. The current study will fill this gap in the evidence base and compare the outcomes of delivering the same exercise interventions in a facility or in the home/community using a telerehab approach. The interventions are designed to be identical in content, with the only difference being the mode of training delivery.

Funded by Patient-Centered Outcomes Research Institute (PCORI), this four-year, multi-site study aims to compare the effectiveness of a 16-week telerehabilitation (telerehab) exercise program and a facility-based exercise program on Multiple Sclerosis (MS) outcomes. The research study design is a two-stage randomized choice design aimed at non-inferiority. Four hundred participants with MS who have ambulatory difficulties will be recruited from nine sites. First level randomization will assign participants to one of two groups - Choice or Random. The participants in Choice will be able to choose in which program they wish to participate (telerehab or facility-based). Individuals in the Random group, will be further randomized to either the telerehab or facility-based program. The research protocol and associated tools will be reviewed and approved by all relevant Research Review Committees before any research takes place. The study will comply with best practices in human subjects' research including following HIPAA guidelines and using strict informed consent procedures. Clinical reported outcome measures and patient reported outcome measures will be administered at baseline, immediately post-intervention (at 16 weeks), and at 12 months post-intervention. Patient reported outcomes will also be administered at 2 months and 6 months after the start of the intervention. Dr. Deborah Backus is the principal investigator (PI) and Prof. Robert Motl is the co-Principal Investigator supported by collaborating co-Investigators at the Cleveland Clinic Mellen Center, Ohio; Marquette University, Wisconsin; University of Colorado, Denver; University of North Carolina, Chapel Hill; the University of Georgia; the Tanner Center for Multiple Sclerosis, Birmingham Alabama; Massachusetts General Hospital, Boston, Massachusetts; and the iConquerMS outcomes data collaborative (Accelerated Cure Project for MS). Shepherd Center is the primary and coordinating site for all study activities under Dr. Backus. University of Alabama at Birmingham (UAB) under the leadership of Prof. Motl will oversee delivery of the training programs, and statistical analysis under the direction of Dr. Gary Cutter. This study will yield important data regarding the comparative impact of exercise programs on MS outcomes and provide information to people with MS, health providers, payers, exercise partners, and policy makers about how people with MS who have ambulatory difficulties can safely and effectively exercise.

Multiple sclerosis, Exercise, Physical activity, Telerehabilitation, Comparative effectiveness study, Social cognitive theory, Health behavior change

Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.

Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.

The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.

Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention

Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention

Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention

A self-report measure of fatigue in people with MS. The total score for the MFIS is the sum of the scores for the 22 items and can range from 0 to 88. Higher scores indicate a greater impact of fatigue on a person's activities.

Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention

Measures individual's views on the impact of MS on day-to-day life during the past two weeks. It has two subscales: a 20-item physical impact scale and a 9-item psychological impact scale (and no total score). Scores on the physical impact scale can range from 20 to 80 and on the psychological impact scale from 9 to 36, with lower scores indicating little impact of MS and higher scores indicating greater impact.

Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention

Measures impact of fatigue on the participant's activities and lifestyle over the past four weeks. The total score for the MFIS is the sum of the scores for the 21 items and can range from 0 to 84. Higher scores indicate a greater impact of fatigue on a person's activities.

Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention

A battery of measures to measure the core SCT constructs of self-efficacy, outcome expectations, goal setting, self-monitoring, overcoming barriers, perceived social support.

Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention

Characterizes disability level and determines disability progression in people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability (0 equals low).

Inclusion Criteria: Mild to moderate MS Has limitations in walking but can walk 25 feet Does not participate in a rigorous exercise program Can travel to trial site for assessments and training Exclusion Criteria: Relapse in the past 30 days Other neurological or musculoskeletal disorders