Physiotherapist-guided Home Exercise in Moderate to Severe MS

NCT03039400 | Completed

• 1 other identifier: Bio 16-280
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adherence to prescribed exercise program

  Measured by number of completed exercise sessions on exercise diary

  6 months

Secondary Outcomes (8)

• Injury or fall

  6 months

• Multiple Sclerosis Impact Scale (MSIS29 v.2)

  6 months

• Godin Leisure Time Exercise Questionnaire (GLTEQ)

  6 months

• Grip strength measured on hand dynamometer

  6 months

• Timed 25-Foot Walk Test

  6 months

Study Arms (2)

Web-based physio group

EXPERIMENTAL

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.

Behavioral: Physiotherapist-guided home exercise with web-based support

Standard care group

ACTIVE COMPARATOR

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.

Behavioral: Physiotherapist-guided home exercise with standard support

Interventions

Physiotherapist-guided home exercise with web-based support 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.

Web-based physio group

Physiotherapist-guided home exercise with standard support 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.

Standard care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Multiple Sclerosis Society of Canada: collaborator

Study Sites (1)

Department of Physical Medicine & Rehabilitation, University of Saskatchewan

Saskatoon, Saskatchewan, S7K 0M7, Canada

Location

Related Publications (2)

• 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.

  PMID: 33177956 RESULT

• 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.

  PMID: 35341443 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Katherine Knox, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: February 1, 2017
• Study Start: March 6, 2017
• Primary Completion: October 11, 2018
• Study Completion: October 11, 2018
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

CA (1)