Delivery of a Culturally Tailored Exercise Training Intervention for Hispanics With Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to establish differences in the primary outcome of walking dysfunction using the 12-Item Multiple Sclerosis Walking Scale (MSWS-12) and to establish differences in the secondary outcome of HRQoL using the 29-Item Multiple Sclerosis Walking Scale (MSWS-29) between the exercise training intervention condition and the waitlist control condition following the 16-week intervention period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of MS

relapse-free in the past 30 days

self-identify as Hispanic/Latino

Patient Determined Disease Steps Scale (PDDS) score between 3.0 (gait disability) and 6.0 (bilateral support) indicates walking disability.

Disqualifiers

significant exercise-related risk factors or contraindications, assessed individually using the Physical Activity Readiness Questionnaire (PAR-Q; requires clearance from physician).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise Training

    Behavioral

    Participants will then be mailed exercise materials in their preferred language, including the program manual, logbook, calendar, newsletters, Fitbit, and resistance bands, along with instructions for telephone or video conference calls. This is a 16-week, home-based program, supported remotely via Internet-based behavioral coaching, which integrates behavior change techniques based on Social Cognitive Theory (SCT)

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Exercise TrainingExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in walking ability as assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)

This is a 12 item questionnaire and each is scored on a 5-point Likert scale from 1(not at all) to 5(extremely). Total raw scores ranging from 12-60 are converted into standardized scores from 0-100, with higher scores indicating greater perceived walking impairment related to multiple sclerosis.

Time frame
Baseline, 16 weeks, 32 weeks

Secondary outcomes

1

Change in HRQoL as assessed by the 29-Item Multiple Sclerosis Walking Scale (MSWS-29)

This is a 29 item questionnaire and each is scored from 1( not at all) to 5(extremely) , with a Raw score range from 29 to 145. This is then converted into a standardized scale from 0 to 100, with higher scores indicating worse walking impairment and greater impact of multiple sclerosis on mobility.

Time frame
Baseline, 16 weeks, 32 weeks

Other outcomes

Sponsors and contacts

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The University of Texas Health Science Center, Houston

Lead sponsor

National Institutes of Health (NIH)

Collaborator