An Early Phase 1 interventional study of Remotely Delivered and Supported Aerobic Walking Exercise Training and Remotely Delivered and Supported Stretching and Toning Exercise Training in Multiple Sclerosis, sponsored by Kessler Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by Kessler Foundation · Early Phase 1, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.
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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.
Behavioral: Remotely Delivered and Supported Aerobic Walking Exercise Training
Behavioral: Remotely Delivered and Supported Stretching and Toning 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.
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.
Change in Cognitive Processing Speed
Cognitive processing speed will be measured using the Symbol Digit Modalities Test. The primary outcome measure is the total score.
Time frame: 16 weeks
Change in Verbal Learning and Memory
Verbal learning and memory will be measured using the learning trials of the California Verbal Learning Test-II. The primary outcome measure is the total learning score.
Time frame: 16 weeks
Plan to share: No
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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