NCT07891520

Brief Summary

The purpose of this study is to assess changes in the outcome of exercise behavior between the SPIN exercise-training condition and the WEllness for Longevity Living (WELL) attention/contact wellness control condition and to examine differences in exercise behavior, functioning, disability, and health between the SPIN and WELL conditions

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
25mo left

Started Jan 2027

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

October 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

January 4, 2027

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2029

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2029

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

2 years

First QC Date

October 16, 2026

Last Update Submit

October 16, 2026

Conditions

Keywords

exercise

Outcome Measures

Primary Outcomes (2)

  • Change in self reported total minutes per week of moderate-to-vigorous physical activity (MVPA)

    Baseline , 16 weeks.

  • Change in strength training, assessed by the Leisure Time Physical Activity Questionnaire for People with Disabilities (LTPAQ-D)

    Participants report the number of days and average minutes per day spent in mild-, moderate-, and vigorous-intensity aerobic activities during the previous 7 days. Weekly minutes are calculated separately for each intensity and summed to obtain total aerobic physical activity, expressed in minutes per week. Higher values indicate greater participation in leisure-time aerobic physical activity

    Baseline , 16 weeks

Secondary Outcomes (5)

  • Change in device-measured exercise behavior

    Baseline , 16 weeks

  • Change in Upper-limb function as assessed by the Nine-Hole Peg Test

    Baseline , 16 weeks

  • Change in Upper-limb function as assessed by the Grip strength using the hand dynamometer

    Baseline , 16 weeks

  • Change in Disability / Activities of Daily Living ( ADL) as assessed by the Barthel Index score

    Baseline , 16 weeks

  • Change in Health-Related Quality of Life as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)

    Baseline , 16 weeks

Study Arms (2)

SPIN exercise-training condition

EXPERIMENTAL
Behavioral: SPIN exercise-training

WELL attention/contact wellness control condition

ACTIVE COMPARATOR
Behavioral: Control Condition (WELL)

Interventions

Participants complete three days of both modalities each week, with at least one day of rest between resistance sessions. For the first two weeks, all participants begin at 10-minute aerobic sessions and 1 set of 10 repetitions of five resistance exercises. The aerobic goal is to progress to 30-minute sessions (90 minutes/week) using a cycle (arm) ergometer; the resistance goal is 2 sets of 15 repetitions of 10 exercises (\~60 minutes/week). After two weeks, participants select one of three progression tracks (white, blue, or orange) with their coach. The final overall goal is 30 minutes of aerobic exercise plus 10 resistance exercises for two sets of 15 repetitions, three days per week (\~150 minutes/week of MVPA).The total time is 16 weeks.

SPIN exercise-training condition

The WELL attention/contact control mirrors SPIN in coaching schedule and materials but focuses on health behaviors other than physical activity (diet, emotions, stress, sleep, fatigue, and falls). It is based on Social Cognitive Theory (SCT) principles and integrates National Multiple Sclerosis Society (NMSS) wellness resources. WELL includes 12 newsletters (Diet, Sleep, Stress, Balance, Cognition, and Fatigue).

WELL attention/contact wellness control condition

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of multiple sclerosis (MS).
  • Self-reported use of a wheelchair (manual wheelchair, power wheelchair, or scooter) ≥50% of the time.
  • Relapse-free for the past 30 days.
  • Godin Leisure Time Exercise Questionnaire Health Contribution Score \<14 units (i.e., not meeting current physical activity guidelines).

You may not qualify if:

  • An MS relapse within the past 30 days

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 SclerosisMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stephanie L Silveira, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 16, 2026

First Posted

October 23, 2026

Study Start (Estimated)

January 4, 2027

Primary Completion (Estimated)

January 2, 2029

Study Completion (Estimated)

February 5, 2029

Last Updated

October 23, 2026

Record last verified: 2026-10

Locations