Remote Exercise Effects on Cognitive Processing Speed in Multiple Sclerosis: A Pilot Trial
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Cognitive processing speed (CPS) impairment is prevalent, impactful, and poorly-managed in
      multiple sclerosis (MS). Upwards of 67% of patients present with MS-related CPS impairment,
      which is associated with poor everyday life outcomes. There are no FDA-approved
      pharmacological treatments for CPS impairment in MS. This landscape creates a critical public
      health and clinical crisis that underscores the importance of identifying efficacious
      approaches for managing CPS impairment in MS. We believe that aerobic exercise training
      represents a promising and powerful behavioral approach. This project involves a single-blind
      randomized controlled trial of 16-weeks of remotely-delivered and supported aerobic walking
      exercise training compared with an active control condition (remotely-delivered and supported
      stretching and toning activities) on CPS (assessed remotely) in 24 fully-ambulatory, but
      CPS-impaired persons with MS.

      This pilot trial will be conducted in a fully-remote fashion, such that there are no required
      in-person visits to Kessler Foundation. Participants (N=24) will initially undertake baseline
      assessments of CPS remotely via a HIPAA-compliant virtual platform (i.e., Zoom for
      Healthcare). This assessment will also serve as a screen for ensuring impaired CPS. At this
      virtual study visit, participants further will undergo a neuropsychological test of verbal
      learning and complete questionnaires assessing physical activity and MS symptoms via computer
      (REDCap). Following baseline, participants will be randomly assigned into the
      remotely-delivered and supported aerobic walking exercise training intervention condition
      (n=12) or remotely-delivered and supported attention and social contact control condition
      (n=12) using concealment. Both conditions will be administered remotely over 16-weeks via
      telerehabilitation by a postdoctoral behavior coach during scheduled calls. Participants will
      undertake aerobic walking exercise training or stretching-and-toning in the home/community.
      The exercise training intervention involves aerobic walking exercise training that is
      monitored by a waist-worn FitBit and follows prescriptive guidelines for aerobic exercise for
      persons with MS. The control condition involves stretching-and-toning based on a manual
      published by the National Multiple Sclerosis Society. Both conditions further involve
      one-on-one coaching, action-planning via calendars, logs for self-monitoring, and newsletters
      based on Social Cognitive Theory. After the 16-week exercise/control period, participants
      will undergo remote assessments of CPS and verbal learning (administered by a
      treatment-blinded assessor) as well as completion of questionnaires assessing physical
      activity and MS symptoms via REDCap.

      If successful, this RCT will provide preliminary data on the extent to which (a)
      remotely-delivered/supported aerobic walking ET results in significant CPS improvements in
      CPS-impaired persons with MS; and (b) the intervention results in increased physical activity
      relative to an active control in a cognitively-impaired cohort. These pilot data will be
      essential for supporting a large R01 application on a multi-site, effectiveness RCT in a
      nationwide sample of CPS-impaired persons with MS.
    


Intervention name(s): Remotely Delivered and Supported Aerobic Walking Exercise Training; Remotely Delivered and Supported Stretching and Toning Exercise Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This condition will include 16-weeks of remotely-delivered and supported aerobic walking exercise training based on guidelines for physical activity in persons with MS for general health benefits. Exercise intensities will be prescribed based on steps per exercise sessions from a waist-worn FitBit One™ (FitBit, Inc., San Francisco, CA).
The exercise program involves one-on-one semi-structured sessions with an MS exercise specialist (i.e., behavior coach) throughout the program. These sessions focus on exercise training guidance and oversight, discussion of the behavioral strategies of action planning and self-monitoring, and presentation and discussion of newsletters for optimizing exercise compliance.; The active, non-aerobic exercise condition will involve stretching-and-toning activities. These activities will be based on a manual provided by the National Multiple Sclerosis Society. Participants will be provided with necessary exercise equipment (e.g., yoga mat, FitBit), an instructional DVD, and a manual, log-book, calendar, and prescription for the stretching program. This program will be supplemented with periodic newsletters delivered electronically that highlight principles of behavior change, and video-chats with a behavior coach that provide motivation and social accountability. These occur on the same timeline and frequency as in the walking condition, but focus on constructs for stretching.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Physical Activity; Cognition; Walking; Stretching