- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07606742
Delivery of a Culturally Tailored Exercise Training Intervention for Hispanics With Multiple Sclerosis (VAMOS-MS)
May 18, 2026 updated by: Stephanie Lee Silveira, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephanie L Silveira, PhD
- Phone Number: (713) 500-9490
- Email: Stephanie.L.Silveira@uth.tmc.edu
Study Contact Backup
- Name: Najha Black
- Phone Number: 713-500-9154
- Email: Najha.C.Marshall@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
Contact:
- Najha Black
- Phone Number: 713-500-9154
- Email: Najha.C.Marshall@uth.tmc.edu
-
Contact:
- Stephanie L Silveira, PhD
- Phone Number: (713) 500-9000
- Email: Stephanie.L.Silveira@uth.tmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waitlist Control
|
|
|
Experimental: 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in walking ability as assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)
Time Frame: Baseline, 16 weeks, 32 weeks
|
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.
|
Baseline, 16 weeks, 32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in HRQoL as assessed by the 29-Item Multiple Sclerosis Walking Scale (MSWS-29)
Time Frame: Baseline, 16 weeks, 32 weeks
|
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.
|
Baseline, 16 weeks, 32 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stephanie L Silveira, PhD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
October 31, 2028
Study Registration Dates
First Submitted
May 18, 2026
First Submitted That Met QC Criteria
May 18, 2026
First Posted (Actual)
May 26, 2026
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Multiple Sclerosis
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- HSC-SPH-25-0341
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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