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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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University of Illinois

Status

Enrolling

Conditions

Multiple Sclerosis

Treatments

Behavioral: Guidelines for Exercise in Multiple Sclerosis (GEMS)
Behavioral: FLEX Stretching and Toning Program

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05516537
2022-0526
20016 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Guidelines for Exercise in Multiple Sclerosis (GEMS)
Experimental group
Description:
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).
Treatment:
Behavioral: Guidelines for Exercise in Multiple Sclerosis (GEMS)
FLEX Stretching and Toning Program
Sham Comparator group
Description:
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.
Treatment:
Behavioral: FLEX Stretching and Toning Program

Trial contacts and locations

1

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Central trial contact

Robert W Motl, PhD; Edson Flores, MPH

Data sourced from clinicaltrials.gov

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