- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05516537
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)
January 10, 2024 updated by: Robert W Motl, University of Illinois at Chicago
Promotion of Exercise Behavior Among Rural-Residing African-Americans With Multiple Sclerosis
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).
Study Overview
Status
Recruiting
Conditions
Detailed Description
There is a lack of evidence from high-quality randomized controlled trials (RCTs) of exercise training for African-Americans with multiple sclerosis (MS), as only 1.7% of participants in physical activity and exercise research involving persons with MS identify as African-American.
The population of African-Americans with MS deserves equal and focal research that addresses the unique challenges of MS in the African-American rural residing community.
We uniquely address this population with a highly-developed and refined exercise training program that is racially-tailored for the target population.
We further provide a highly-developed and refined exercise training program that can be undertaken in one's home and/or local community, and does not require facility access that is extremely limited in the target, rural residing population of persons with MS.
The program is further tailored based on qualitative research and addresses the unique needs of the African-American community with MS.
There is no other research program this advanced in study refinement and design for immediate integration into a high-quality RCT for changing the lives of African-Americans with MS who reside in rural communities of the Southeastern portion of the United States.
If successful, the study, as designed, will provide Class I evidence that is necessary for immediate implementation after trial completion through insurance providers and healthcare providers, including physical therapists, rehabilitation practitioners, and community health workers/providers.
This program further aligns with recently developed and highly-refined conceptual and practice models for implementation of exercise into the care of persons with MS.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Robert W Motl, PhD
- Phone Number: 205-975-1306
- Email: robmotl@uic.edu
Study Contact Backup
- Name: Edson Flores, MPH
- Phone Number: 312-413-4967
- Email: eflore42@uic.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois at Chicago
-
Contact:
- Robert W Motl, PhD
- Phone Number: 205-975-1306
- Email: robmotl@uic.edu
-
Contact:
- Edson Flores, MPH
- Phone Number: 312-413-4967
- Email: eflore42@uic.edu
-
Principal Investigator:
- Robert W Motl, PhD
-
Sub-Investigator:
- Edson Flores, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Individuals not meeting above inclusion criteria
- Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guidelines for Exercise in Multiple Sclerosis (GEMS)
Participants 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).
|
Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training.
|
Sham Comparator: FLEX Stretching and Toning Program
Participants 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.
|
Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking Dysfunction
Time Frame: Changes in walking scores from Baseline, 4-months, and 8-months.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability
Time Frame: Changes in disability scores from Baseline, 4-months, and 8 months.
|
Patient Determined Disease Steps (PDDS) scale; scores range between 0 (min) and 8 (max), higher score reflect greater perceived disability.
|
Changes in disability scores from Baseline, 4-months, and 8 months.
|
Fatigue Severity
Time Frame: Changes in fatigue from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
|
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
|
Changes in fatigue from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
|
Depressive Symptoms
Time Frame: Changes in depressive symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
|
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
|
Changes in depressive symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
|
Anxiety
Time Frame: Changes in anxiety symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
|
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
|
Changes in anxiety symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
|
Health-related Quality of Life (HRQOL)
Time Frame: Changes in quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
|
Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e.
worse outcomes).
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Changes in quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Behavior
Time Frame: Changes in exercise behavior from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
|
Godin Leisure Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in exercise behavior.
|
Changes in exercise behavior from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert W Motl, PhD, University of Illinois at Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2022
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
August 23, 2022
First Submitted That Met QC Criteria
August 23, 2022
First Posted (Actual)
August 25, 2022
Study Record Updates
Last Update Posted (Estimated)
January 11, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0526
- 20016 (Other Grant/Funding Number: Bristol Myers Squibb Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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