Comparative Effectiveness Study Telerehab Versus Conventional

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Exercise program for people with MS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-stage randomized choice design aimed at noninferiority.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Facility-based rehabilitation<br>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. | Behavioral: Exercise program for people with MS<br>* The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.<br>|
| Active Comparator: Telerehabilitation<br>Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions. | Behavioral: Exercise program for people with MS<br>* The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 25 Foot Walk Test (T25FWT) | Measure of walking speed | Change from baseline T25FWT at 16-weeks and at 12 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Test | Measures walking endurance | Change from baseline at 16 weeks and 12 months post intervention | 
| Multiple Sclerosis Walking Scale-12 questionnaire | Measures the impact of MS on walking ability and daily activities over the past two weeks | Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention | 
| Godin Leisure-Time questionnaire | 7-day recall of leisure-time physical activity to determine individual's activity level | Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention | 
| Quality of Life in Neurological Disorders (Neuro-QOL) survey | A validated outcome measure of quality of life | Change from baseline at 8 weeks, at 16 weeks, at 6 months post intervention, and at 12 months post intervention | 
| Unidimensional Fatigue Impact Score | 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 | 
| Multiple Sclerosis Impact Scale-29 | 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 | 
| Modified Fatigue Impact Scale | 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 | 
| Social Cognitive Theory (SCT) | 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 | 
| Expanded Disability Status Scale | 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). | Change from baseline at 16 weeks and 12 months post intervention | 
| Patient Determined Disease Steps | Patient reported measure of disability in MS. The scale ranges from 0 to 8. | Change from baseline at 16 weeks and 12 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Physical activity, Multiple sclerosis, Telerehabilitation, Comparative effectiveness study, Social cognitive theory, Health behavior change