Remotely Delivered and Supported Aerobic Walking Exercise Training for Multiple Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kessler Foundation, West Orange, NJ
Multiple Sclerosis+1 More
Remotely Delivered and Supported Aerobic Walking Exercise Training - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 16 weeks

16 weeks
Change in Cognitive Processing Speed
Change in Verbal Learning and Memory

Trial Safety

Trial Design

2 Treatment Groups

Remotely Delivered and Supported Stretching and Toning
1 of 2
Remotely Delivered and Supported Aerobic Walking Exercise Training
1 of 2
Active Control
Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Remotely Delivered and Supported Aerobic Walking Exercise Training · No Placebo Group · Phase < 1

Remotely Delivered and Supported Aerobic Walking Exercise Training
Behavioral
Experimental Group · 1 Intervention: Remotely Delivered and Supported Aerobic Walking Exercise Training · Intervention Types: Behavioral
Remotely Delivered and Supported Stretching and Toning
Behavioral
ActiveComparator Group · 1 Intervention: Remotely Delivered and Supported Stretching and Toning Exercise Training · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks

Trial Background

Brian Sandroff, Principal Investigator
Principal Investigator
Kessler Foundation
Closest Location: Kessler Foundation · West Orange, NJ
2006First Recorded Clinical Trial
22 TrialsResearching Multiple Sclerosis
57 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have a definite diagnosis of MS.
You are willing to complete the study.
You will be between the ages of 18 and 65.
Participants will not have uncontrolled major depression disorder or a history of other significant psychiatric disorders (e.g., bipolar disorder I or II, schizophrenia).
You are free from exacerbations and not have taken corticosteroids for 30 days prior to enrollment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.