Physiotherapist-guided Home Exercise in Moderate to Severe MS

Study Overview
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Brief Summary
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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.

Official Title
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Physiotherapist-guided Home Exercise in Moderate to Severe Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Physiotherapist-guided home exercise with web-based support
* Behavioral: Physiotherapist-guided home exercise with standard support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based physio group<br>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<br>* 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.<br>|
| Active Comparator: Standard care group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to prescribed exercise program | Measured by number of completed exercise sessions on exercise diary | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury or fall | Participants will be asked to contact their treating physiotherapist in the event of new pain, 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 | 
| Timed Up and Go |  | 6 months | 
| FIM (R) instrument | The FIM (R) instrument, data set and impairment codes referenced herein are the property of Uniform Data System for Medical Rehabilitation, a division of UB Foundation Activities, Inc. | 6 months | 
| Hospital Anxiety and Depression Scale |  | 6 months |