NCT03468868

Brief Summary

This study aims to compare the effectiveness of an exercise program delivered in a conventional facility-based format versus a telerehabilitation format, which takes place in the home. Exercise can improve mobility and perhaps decrease the rate and extent of disability in people with MS. Evidence shows that traditional, facility-based exercise training may help people with MS consistently participate in exercise or to exercise at a higher, more intense level. Despite this evidence, lack of access to facility-based exercise programs may make it difficult for people with MS to engage in exercise.Telerehabilitation (telerehab) has great potential to overcome challenges associated with facility-based programs. Telerehab can include videoconferencing, remote monitoring of signs and activity, and dissemination of specialized and individualized information via electronic mechanisms, such as smartphones and computers. Both facility-based and telerehab exercise training have yielded positive results in people with MS, but have not been compared head-to-head. The current study will fill this gap in the evidence base and compare the outcomes of delivering the same exercise interventions in a facility or in the home/community using a telerehab approach. The interventions are designed to be identical in content, with the only difference being the mode of training delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
379

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

9 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 23, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 9, 2024

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

5.1 years

First QC Date

March 6, 2018

Results QC Date

July 11, 2024

Last Update Submit

January 9, 2025

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisExercisePhysical activityTelerehabilitationComparative effectiveness studySocial cognitive theoryHealth behavior change

Outcome Measures

Primary Outcomes (1)

  • Timed 25 Foot Walk Test (T25FWT)

    The Timed 25 Foot Walk Test (T25FWT) is a measure of walking speed. Individuals are instructed to walk 25 feet as quickly and safely as possible from one marked end to the other. Higher walking speed (feet per second) indicate improved walking function.

    Change from baseline T25FWT at 16-weeks

Secondary Outcomes (8)

  • Six Minute Walk Test (6MWT)

    Change from baseline at 16 weeks

  • Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire

    Change from baseline at 16 weeks

  • Godin Leisure-Time Physical Activity (LTPA) Questionnaire

    Change from baseline at 16 weeks

  • Quality of Life in Neurological Disorders (Neuro-QOL) Survey

    Change from baseline at 16 weeks.

  • Multiple Sclerosis Impact Scale (MSIS)-29

    Change from baseline at 16 weeks.

  • +3 more secondary outcomes

Study Arms (2)

Facility-based rehabilitation

ACTIVE COMPARATOR

Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.

Behavioral: Exercise program for people with MS

Telerehabilitation

ACTIVE COMPARATOR

Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.

Behavioral: Exercise program for people with MS

Interventions

Exercise program for people with MSBEHAVIORAL

The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.

Facility-based rehabilitationTelerehabilitation

Eligibility Criteria

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

You may qualify if:

  • Mild to moderate MS
  • Has limitations in walking but can walk 25 feet
  • Does not participate in a rigorous exercise program
  • Can travel to trial site for assessments and training

You may not qualify if:

  • Relapse in the past 30 days
  • Other neurological or musculoskeletal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The Tanner Center for Multiple Sclerosis

Birmingham, Alabama, 35209, United States

Location

University of Alabama

Birmingham, Alabama, 35209, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

University of Georgia

Athens, Georgia, 30602, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of North Carolina

Raleigh, North Carolina, 27599, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Marquette University

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (6)

  • Motl RW, Backus D, Neal WN, Cutter G, Palmer L, McBurney R, Schmidt H, Bethoux F, Hebert J, Ng A, McCully KK, Plummer P. Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis. Contemp Clin Trials. 2019 Jun;81:110-122. doi: 10.1016/j.cct.2019.04.013. Epub 2019 Apr 22.

    PMID: 31022481BACKGROUND

  • Neal WN, Moldavskiy M, Truax B, Ithurburn A, Ware M, Hebert JR, Opielinski L, Penko AL, Kern K, Palmer L, Backus D, Motl RW. Intervention fidelity and adaptation in a multi-site exercise training intervention for adults with multiple sclerosis. Contemp Clin Trials. 2023 Oct;133:107320. doi: 10.1016/j.cct.2023.107320. Epub 2023 Aug 24.

    PMID: 37633458BACKGROUND

  • Palmer LC, Neal WN, Motl RW, Backus D. The Impact of COVID-19 Lockdown Restrictions on Exercise Behavior Among People With Multiple Sclerosis Enrolled in an Exercise Trial: Qualitative Interview Study. JMIR Rehabil Assist Technol. 2022 Nov 22;9(4):e42157. doi: 10.2196/42157.

    PMID: 36269870BACKGROUND

  • Motl RW, Plummer P, Backus D, Hebert JR, Neal WN, Ng A, Lowman J, Bethoux F, Schmidt H, McBurney R, McCully KK, Cutter G. Validation of scores from a telephone administered multiple sclerosis walking scale-12 in persons with multiple sclerosis. Mult Scler Relat Disord. 2024 Aug;88:105715. doi: 10.1016/j.msard.2024.105715. Epub 2024 Jun 9.

    PMID: 38889558BACKGROUND

  • Motl RW, Backus D, Hebert JR, Ng AV, McCully KK, Neal WN, Schmidt H, McBurney R, Plummer P, Bethoux F, Lowman J, Cutter G. Walking performance is worse in black than white people with multiple sclerosis. Mult Scler Relat Disord. 2025 Mar;95:106343. doi: 10.1016/j.msard.2025.106343. Epub 2025 Feb 18.

    PMID: 39986137DERIVED

  • Motl R, Neal W, Backus D, Hebert J, McCully K, Bethoux F, Plummer P, Ng A, Lowman J, Schmidt H, McBurney R, Cutter G. Middle-range scores from the patient determined disease steps scale reflect varying levels of walking dysfunction in multiple sclerosis. BMC Neurol. 2024 Oct 10;24(1):383. doi: 10.1186/s12883-024-03871-1.

    PMID: 39390466DERIVED

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Deborah Backus, PT, PhD
Organization
Shepherd Center, Atlanta, GA
deborah.backus@shepherd.org
404-352-2020

Study Officials

  • Deborah Backus, PT, PhD

    Shepherd Center, Atlanta GA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluators who assess clinical reported outcomes will be blinded to arm assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two-stage randomized choice design aimed at noninferiority.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Multiple Sclerosis Research

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 19, 2018

Study Start

July 23, 2018

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

January 13, 2025

Results First Posted

December 9, 2024

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(9)