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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)

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ClinicalTrials.gov Identifier: NCT05516537
Recruitment Status : Recruiting
First Posted : August 25, 2022
Last Update Posted : November 2, 2022
Sponsor:
Collaborators:
University of Alabama at Birmingham
Bristol-Myers Squibb Foundation
Information provided by (Responsible Party):
Robert W Motl, University of Illinois at Chicago

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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Guidelines for Exercise in Multiple Sclerosis (GEMS) Behavioral: FLEX Stretching and Toning Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Promotion of Exercise Behavior Among Rural-Residing African-Americans With Multiple Sclerosis
Actual Study Start Date : September 2, 2022
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2025


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).
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05516537


Contacts
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Contact: Robert W Motl, PhD 205-975-1306 robmotl@uic.edu
Contact: Edson Flores, MPH 312-413-4967 eflore42@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Robert W Motl, PhD    205-975-1306    robmotl@uic.edu   
Contact: Edson Flores, MPH    312-413-4967    eflore42@uic.edu   
Principal Investigator: Robert W Motl, PhD         
Sub-Investigator: Edson Flores, MPH         
Sponsors and Collaborators
University of Illinois at Chicago
University of Alabama at Birmingham
Bristol-Myers Squibb Foundation
Investigators
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Principal Investigator: Robert W Motl, PhD University of Illinois at Chicago
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Responsible Party: Robert W Motl, Robert W. Motl, PhD, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT05516537    
Other Study ID Numbers: 2022-0526
20016 ( Other Grant/Funding Number: Bristol Myers Squibb Foundation )
First Posted: August 25, 2022    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert W Motl, University of Illinois at Chicago:
Rural
Walking dysfunction
Health-Related Quality of Life
African-American
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases