Comparative Effectiveness Study Telerehab Versus Conventional
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Exercise program for people with MS
Intervention type(s): Behavioral
Intervention description(s): The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-stage randomized choice design aimed at noninferiority.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Multiple sclerosis; Exercise; Physical activity; Telerehabilitation; Comparative effectiveness study; Social cognitive theory; Health behavior change