Examining the Effects of a Remotely-delivered, Racially-tailored Exerc

Promotion of Exercise Behavior Among Rural-Residing African-Americans With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT05516537

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Guidelines for Exercise in Multiple Sclerosis (GEMS)

Placebo

  • FLEX Stretching and Toning Program

What it measured

Main measures

  • Walking Dysfunction

    Changes in walking scores from Baseline, 4-months, and 8-months.

    Walking and mobility

Other measures (5)

  • Disability

    Changes in disability scores from Baseline, 4-months, and 8 months.

  • Fatigue Severity

    Changes in fatigue from Baseline, after 4-month intervention period, and 4 months after intervention cessation.

    Fatigue

  • Depressive Symptoms

    Changes in depressive symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.

    Mood and sleep

  • Anxiety

    Changes in anxiety symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.

    Mood and sleep

  • Health-related Quality of Life (HRQOL)

    Changes in quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation.

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full 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).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

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History

    1. Started

      Sept 2022

    2. Main results due

      Dec 2025

    3. Finished

      Jan 2026

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