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)

June 2, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Robert W Motl, PhD
  • Phone Number: 205-975-1306
  • Email: robmotl@uic.edu

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: 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.
Behavioral: FLEX Stretching and Toning Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
Changes in quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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