The Feasibility and Efficacy of a Remotely Delivered Exercise Training Intervention for the Hispanic/Latino Community With Multiple Sclerosis

Stopped earlyNot a drug-phase studyMS (type not specified)NCT05998616

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: The study was terminated early due to NIH funding withdrawal before reaching the planned sample size of 50 participants. Thirty-three participants enrolled, 30 were randomized, and 26 completed follow-up assessments.

What was tested

Treatment tested

  • Exercise Training Program

Compared with

  • Flexibility Program

Results by group

Process: Participant Recruitment and Retention

Before, During, and After 16 weeks, pre-, intra- and post-Intervention

GroupValueIntervalNumber analysed
Experimental (GEMS-based)14 Participants15
Active Comparator12 Participants15
Experimental (GEMS-based)1 Participants15
Active Comparator3 Participants15

Experimental (GEMS-based)

14

Active Comparator

12

Experimental (GEMS-based)

1

Active Comparator

3

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Experimental (GEMS-based)150 (0.0%)0
Active Comparator150 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Process: Participant Recruitment and Retention

    Before, During, and After 16 weeks, pre-, intra- and post-Intervention

    Feasibility

Other measures (7)

  • Lower Extremity Function

    Post-intervention at 16 weeks

  • Visual Processing Speed

    Post-intervention at 16 weeks

    Thinking and memory
  • Verbal Learning and Memory

    Post-intervention at 16 weeks

    MRI lesionsThinking and memory
  • Fatigue Severity

    Post-intervention at 16 weeks

    Fatigue
  • Depression and Anxiety Symptoms

    Post-intervention at 16 weeks

    Mood and sleep
  • Exercise Behavior

    Post-intervention at 16 weeks

    Physical function
  • Health-related Quality of Life

    Post-intervention at 16 weeks

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

Inclusion criteria

* Age between 18-65 years * Diagnosis of MS * Relapse-free for at least 30 days * Able to walk with or without an assistive device * Insufficient physical activity (i.e., not meeting current physical activity guidelines of 150 minutes of moderate to vigorous physical activity per week) * Willingness to complete all required testing procedures, outcome questionnaires, and randomization * Identify as Hispanic/Latino * Able to speak, read, and understand English * Currently reside in Chicago * Access to the internet and email * Safe for exercise based on the Physical Activity Readiness Questionnaire (PAR-Q)

Exclusion criteria

* Not between 18-65 years * No diagnosis of MS * Not relapse-free for at least 30 days * Not able to walk with or without an assistive device * Too much physical activity (i.e. 150 minutes or more of moderate to vigorous physical activity per week) * Not willing to complete all required testing procedures, outcome questionnaires, and randomization * Do not identify as Hispanic/Latino * Unable to speak, read, and understand English * Not currently residing in Chicago * No access to the internet and email * Not safe for exercise based on the PAR-Q

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

About this trial

In the sponsor's words

The goal of this clinical trial is to investigate the potential benefits of a specially designed exercise program for Hispanics/Latinos with multiple sclerosis (MS). The main questions it aims to answer are: * Can a 4-month remotely-delivered exercise training program improve physical function, symptom management, and quality of life in Hispanics/Latinos with MS? * How do social determinants of health, such as income, education, access to healthcare, and social support, influence the feasibility and effectiveness of the exercise intervention? Participants in this study will engage in a 4-month remotely-delivered exercise training intervention that includes flexibility, or aerobic and resistance exercise training sessions. They will work with experienced coaches who will guide and support them throughout the program. The researchers will compare the participants who receive the exercise intervention with a control group to see if the exercise program leads to significant improvements in physical function, fatigue, mood, and overall well-being for Hispanics/Latinos with MS. The study aims to empower this underserved population and provide insights for future healthcare and research initiatives.

Papers

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History

    1. Started

      Apr 2024

    2. Main results due

      Jun 2025

    3. Finished

      Dec 2025

    4. Results posted

      Aug 2026

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