Delivery of a Culturally Tailored Exercise Training Intervention for Hispanics With Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise Training.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Exercise Training
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)
Primary outcome measures
- Change in walking ability as assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS-12) [Time frame: Baseline, 16 weeks, 32 weeks]
Secondary outcome measures (1)
- Change in HRQoL as assessed by the 29-Item Multiple Sclerosis Walking Scale (MSWS-29) [Time frame: Baseline, 16 weeks, 32 weeks]
Eligibility criteria
Inclusion criteria
- 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.
- MSWS-12 score between 25 and 75, indicating walking disability
- Willingness to complete the questionnaires and undergo randomization
- English or Spanish as a primary language
Exclusion criteria
- significant exercise-related risk factors or contraindications, assessed individually using the Physical Activity Readiness Questionnaire (PAR-Q; requires clearance from physician).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT07606742 · HSC-SPH-25-0341