Comparative Effectiveness Study Telerehab Versus Conventional

NCT ID: NCT03468868

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 379 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2023-09-12

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.

Detailed Description

Funded by Patient-Centered Outcomes Research Institute (PCORI), this four-year, multi-site study aims to compare the effectiveness of a 16-week telerehabilitation (telerehab) exercise program and a facility-based exercise program on Multiple Sclerosis (MS) outcomes. The research study design is a two-stage randomized choice design aimed at non-inferiority.

Four hundred participants with MS who have ambulatory difficulties will be recruited from nine sites. First level randomization will assign participants to one of two groups - Choice or Random. The participants in Choice will be able to choose in which program they wish to participate (telerehab or facility-based). Individuals in the Random group, will be further randomized to either the telerehab or facility-based program. The research protocol and associated tools will be reviewed and approved by all relevant Research Review Committees before any research takes place. The study will comply with best practices in human subjects' research including following HIPAA guidelines and using strict informed consent procedures. Clinical reported outcome measures and patient reported outcome measures will be administered at baseline, immediately post-intervention (at 16 weeks), and at 12 months post-intervention. Patient reported outcomes will also be administered at 2 months and 6 months after the start of the intervention.

Dr. Deborah Backus is the principal investigator (PI) and Prof. Robert Motl is the co-Principal Investigator supported by collaborating co-Investigators at the Cleveland Clinic Mellen Center, Ohio; Marquette University, Wisconsin; University of Colorado, Denver; University of North Carolina, Chapel Hill; the University of Georgia; the Tanner Center for Multiple Sclerosis, Birmingham Alabama; Massachusetts General Hospital, Boston, Massachusetts; and the iConquerMS outcomes data collaborative (Accelerated Cure Project for MS). Shepherd Center is the primary and coordinating site for all study activities under Dr. Backus. University of Alabama at Birmingham (UAB) under the leadership of Prof. Motl will oversee delivery of the training programs, and statistical analysis under the direction of Dr. Gary Cutter.

This study will yield important data regarding the comparative impact of exercise programs on MS outcomes and provide information to people with MS, health providers, payers, exercise partners, and policy makers about how people with MS who have ambulatory difficulties can safely and effectively exercise.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Facility-based rehabilitation

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.

Group Type: ACTIVE_COMPARATOR

Exercise program for people with MS

Intervention Type: BEHAVIORAL

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

Telerehabilitation

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

Group Type: ACTIVE_COMPARATOR

Exercise program for people with MS

Intervention Type: BEHAVIORAL

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

Interventions

Exercise program for people with MS

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

University of Georgia

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Marquette University

OTHER

Sponsor Role: collaborator

Accelerated Cure Project for Multiple Sclerosis

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Tanner Foundation for Multiple Sclerosis

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Shepherd Center, Atlanta GA

OTHER

Sponsor Role: lead

Responsible Party

Deborah Backus

Director of Multiple Sclerosis Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Backus, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shepherd Center, Atlanta GA

Locations

The Tanner Center for Multiple Sclerosis

Birmingham, Alabama, United States

University of Alabama

Birmingham, Alabama, United States

University of Colorado

Denver, Colorado, United States

University of Georgia

Athens, Georgia, United States

Shepherd Center

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of North Carolina

Raleigh, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Marquette University

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31022481 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37633458 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36269870 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38889558 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39986137 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39390466 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MS-1610-36999

Identifier Type: -

Identifier Source: org_study_id