NCT07606742

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
28mo left

Started Jul 2026

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Multiple Sclerosis

Keywords

Exercise trainingmobility disabilityimplementation

Outcome Measures

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.

    Baseline, 16 weeks, 32 weeks

Secondary Outcomes (1)

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

    Baseline, 16 weeks, 32 weeks

Study Arms (2)

Exercise Training

EXPERIMENTAL
Behavioral: Exercise Training

Waitlist Control

NO INTERVENTION

Interventions

Exercise TrainingBEHAVIORAL

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)

Exercise Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stephanie L Silveira, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie L Silveira, PhD

CONTACT

(713) 500-9490Stephanie.L.Silveira@uth.tmc.edu

Najha Black

CONTACT

713-500-9154Najha.C.Marshall@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 26, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

October 31, 2028

Last Updated

May 26, 2026

Record last verified: 2026-05

Locations

US(1)