Examining the Effects of a Remotely-delivered, Racially-tailored Exercise Training Program for Immediate and Sustained Improvements in Walking Dysfunction, Symptoms, and Health-related Quality of Life (HRQOL) Among African-Americans With Multiple Sclerosis (MS) Residing in Rural Environments.
TEAAMS
Promotion of Exercise Behavior Among Rural-Residing African-Americans With Multiple Sclerosis
2 other identifiers
interventional
100
1 country
1
Brief Summary
The proposed project involves a high-quality randomized controlled (RCT) design that examines the effects of a remotely-delivered, racially-tailored exercise training program for immediate and sustained improvement in walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with MS residing in rural environments. The primary analysis will test the hypothesis that those who are randomly assigned into the intervention condition (i.e., exercise training) will demonstrate (a) improvements in outcomes from baseline that (b) are sustained over 4-months of follow-up compared with those in the control condition (i.e., stretching).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Sep 2022
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
August 25, 2022
CompletedStudy Start
First participant enrolled
September 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedSeptember 22, 2025
September 1, 2025
3.2 years
August 23, 2022
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Walking Dysfunction
Multiple Sclerosis Walking Scale-12 (MSWS-12); scores range between 0 (min) and 100 (max), higher scores reflect greater walking problems.
Changes in walking scores from Baseline, 4-months, and 8-months.
Secondary Outcomes (5)
Disability
Changes in disability scores from Baseline, 4-months, and 8 months.
Fatigue Severity
Changes in fatigue from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Depressive Symptoms
Changes in depressive symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Anxiety
Changes in anxiety symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Health-related Quality of Life (HRQOL)
Changes in quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Other Outcomes (1)
Exercise Behavior
Changes in exercise behavior from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Study Arms (2)
Guidelines for Exercise in Multiple Sclerosis (GEMS)
EXPERIMENTALParticipants in this condition will receive a 4-month home-based, remotely supported aerobic and resistance exercise program based on the Guidelines for Exercise in Multiple Sclerosis (GEMS).
FLEX Stretching and Toning Program
SHAM COMPARATORParticipants in this condition will receive a 4-month home-based, remotely supported stretching program emphasizing flexibility and range of motion as important components of fitness based on Stretching for People with MS: An Illustrated Manual from the National MS Society.
Interventions
Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training.
Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training.
Eligibility Criteria
You may qualify if:
- English as primary language
- Identify as African-American or Black
- Age of 18 years or older
- Diagnosis of MS
- Relapse free in the past 30 days
- Internet and email access
- Willingness to complete the outcome questionnaires
- Willingness to undergo randomization
- Insufficient physical activity (not meeting current physical activity guidelines based on GLTEQ)
- Mild-moderate ambulatory disability (MSWS-12 score between 25-49 \& PDDS score between 2-4)
You may not qualify if:
- Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- University of Alabama at Birminghamcollaborator
- Bristol-Myers Squibbcollaborator
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert W Motl, PhD
University of Illinois at Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Robert W. Motl, PhD
Study Record Dates
First Submitted
August 23, 2022
First Posted
August 25, 2022
Study Start
September 2, 2022
Primary Completion
December 1, 2025
Study Completion (Estimated)
August 1, 2026
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share