Physiotherapist-guided Home Exercise in Moderate to Severe MS

NCT ID: NCT03039400

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-06
• Study Completion Date: 2018-10-11

Brief Summary

Physical activity is a crucial component to wellness and is associated with multiple health benefits. Persons with MS may find it challenging to participate in regular physical activity or exercise, which is activity done to improve health and/or fitness. This research will test an innovative web-based intervention to help persons with moderate-to-severe disability manage their condition through a maintenance exercise program with specialized physiotherapist guidance and support. The researchers will examine adherence to the web-based physiotherapy program compared to standard physiotherapy care. Forty-five people with MS will be randomly assigned to the web group or standard care group at a rate of 2:1. Participants in the web group will receive supported and individualized web-based physiotherapy. Participants in the standard care group will receive a written exercise program. Regular participation (adherence) in the exercise programs will be evaluated in both groups over six months. The research will also examine participant satisfaction with the programs, safety, MS symptoms, and physical function. A web-based approach may be widely accessible to persons with MS in their own homes and could support long-term participation in physical activity important to wellness.

Conditions

Multiple Sclerosis

Study Design

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

Study Groups

Web-based physio group

Those in the web-based physio group will have an individual exercise program set up by a treating physiotherapist on webbasedphysio.com after an initial face-to-face assessment. They will be encouraged to undertake their exercise program at least twice per week and diarize their work. Participants will receive a weekly phone call from their treating physiotherapist for the first two weeks. The treating physiotherapist will review the exercise diary of each participant every two weeks, and remotely alter the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions.

Group Type: EXPERIMENTAL

Physiotherapist-guided home exercise with web-based support

Intervention Type: BEHAVIORAL

Those in the web-based physio group will access their exercise program online and will be able to leave messages for their physiotherapist on the platform. Physiotherapists will monitor usage and respond to messages every two weeks.

Standard care group

Those in the standard care group will have their exercise program explained to them at an initial face-to-face assessment with a treating physiotherapist as per usual care. They will receive a written, home-based exercise program. Participants in the usual care group will also be encouraged to undertake their exercise program at least twice per week, and will be asked to keep an exercise diary, in paper format. Participants in the usual care group will also receive a weekly phone call from the physiotherapist for the first two weeks to check on progress.

Group Type: ACTIVE_COMPARATOR

Physiotherapist-guided home exercise with standard support

Intervention Type: BEHAVIORAL

Those in the standard care group will receive a written, home-based exercise program. Participants in the usual care group will be asked to keep an exercise diary, in paper format.

Interventions

Physiotherapist-guided home exercise with web-based support

Those in the web-based physio group will access their exercise program online and will be able to leave messages for their physiotherapist on the platform. Physiotherapists will monitor usage and respond to messages every two weeks.

Intervention Type: BEHAVIORAL

Physiotherapist-guided home exercise with standard support

Those in the standard care group will receive a written, home-based exercise program. Participants in the usual care group will be asked to keep an exercise diary, in paper format.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• diagnosed with MS
• moderate to severe disability (PDDS 2-7)
• able to access the internet in your current living environment

Exclusion Criteria

• already doing structured exercise more than once per week
• residing >300km from Saskatoon (unless able to travel to Saskatoon for the appointments)
• unable to understand the intent and process of this study

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

Sponsors

Multiple Sclerosis Society of Canada

OTHER

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Katherine Knox

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Knox, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Department of Physical Medicine & Rehabilitation, University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

Donkers SJ, Nickel D, Paul L, Wiegers SR, Knox KB. Adherence to Physiotherapy-Guided Web-Based Exercise for Persons with Moderate-to-Severe Multiple Sclerosis: A Randomized Controlled Pilot Study. Int J MS Care. 2020 Sep-Oct;22(5):208-214. doi: 10.7224/1537-2073.2019-048. Epub 2020 Jan 8.

Reference Type: RESULT

PMID: 33177956 (View on PubMed)

Knox KB, Nickel D, Donkers SJ, Paul L. Physiotherapist and participant perspectives from a randomized-controlled trial of physiotherapist-supported online vs. paper-based exercise programs for people with moderate to severe multiple sclerosis. Disabil Rehabil. 2023 Apr;45(7):1147-1153. doi: 10.1080/09638288.2022.2055159. Epub 2022 Mar 28.

Reference Type: DERIVED

PMID: 35341443 (View on PubMed)

Other Identifiers

Bio 16-280

Identifier Type: -

Identifier Source: org_study_id