Remote Exercise Effects on Cognitive Processing Speed in Multiple Sclerosis: A Pilot Trial

NCT ID: NCT05344040

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2022-12-01

Brief 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Remotely Delivered and Supported Aerobic Walking Exercise Training

Group Type: EXPERIMENTAL

Remotely Delivered and Supported Aerobic Walking Exercise Training

Intervention Type: BEHAVIORAL

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.

Remotely Delivered and Supported Stretching and Toning

Group Type: ACTIVE_COMPARATOR

Remotely Delivered and Supported Stretching and Toning Exercise Training

Intervention Type: BEHAVIORAL

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.

Interventions

Remotely Delivered and Supported Aerobic Walking Exercise Training

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.

Intervention Type: BEHAVIORAL

Remotely Delivered and Supported Stretching and Toning Exercise Training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

12. Severe cognitive impairment: Ms. Wells will administer the Telephone Interview for Cognitive Status (TICS-M) over the phone to ensure that all participants can adequately follow directions. In order to pass this inclusion criterion, participants must demonstrate TICS-M scores of 18 or higher. This is critical for ensuring that participants do not have severe cognitive impairment that might preclude the ability to adhere to the conditions, understand intervention content, and interact with the behavior coach.

If the prospective participant with MS passes the above screen, a second-level screening for CPS impairment will take place via Zoom:

a. CPS impairment: All participants will demonstrate impairment in CPS based on Symbol Digit Modalities Test (SDMT) scores at least 1 SD below the age-adjusted normative score for healthy controls.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Brian Sandroff

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Other Identifiers

E-1197-22

Identifier Type: -

Identifier Source: org_study_id