Physiotherapist-guided Home Exercise in Moderate to Severe MS

Multiple Sclerosis Clinical Trial

Official title:

Physiotherapist-guided Home Exercise in Moderate to Severe Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039400
• Other study ID #: Bio 16-280
• Status: Completed
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: October 11, 2018

Study information

• Verified date: April 2021
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 11, 2018
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Department of Physical Medicine & Rehabilitation, University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Multiple Sclerosis Society of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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: 10.7224/15 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to prescribed exercise program	Measured by number of completed exercise sessions on exercise diary	6 months
Secondary	Injury or fall	Participants will be asked to contact their treating physiotherapist in the event of new pain, injury, or fall.	6 months
Secondary	Multiple Sclerosis Impact Scale (MSIS29 v.2)		6 months
Secondary	Godin Leisure Time Exercise Questionnaire (GLTEQ)		6 months
Secondary	Grip strength measured on hand dynamometer		6 months
Secondary	Timed 25-Foot Walk Test		6 months
Secondary	Timed Up and Go		6 months
Secondary	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
Secondary	Hospital Anxiety and Depression Scale		6 months