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.
Official title: Promotion of Exercise Behavior Among Rural-Residing African-Americans With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Rural
Walking dysfunction
Health-Related Quality of Life
African-American
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Bristol-Myers Squibb
First posted: 2022-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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).

Primary outcomes:
measure: Walking Dysfunction
timeFrame: Changes in walking scores from Baseline, 4-months, and 8-months.
Secondary outcomes:
measure: Disability
timeFrame: Changes in disability scores from Baseline, 4-months, and 8 months.
measure: Fatigue Severity
timeFrame: Changes in fatigue from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
measure: Depressive Symptoms
timeFrame: Changes in depressive symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
measure: Anxiety
timeFrame: Changes in anxiety symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
measure: Health-related Quality of Life (HRQOL)
timeFrame: Changes in quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Other outcomes:
measure: Exercise Behavior
timeFrame: Changes in exercise behavior from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Robert W Motl, PhD
role: PRINCIPAL_INVESTIGATOR
References: