Clinical trial NCT03039400: Physiotherapist-guided Home Exercise in Moderate to Severe MS
Official title: Physiotherapist-guided Home Exercise in Moderate to Severe Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Multiple Sclerosis Society of Canada
First posted: 2017-02-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Adherence to prescribed exercise program
timeFrame: 6 months
Secondary outcomes:
measure: Injury or fall
timeFrame: 6 months
measure: Multiple Sclerosis Impact Scale (MSIS29 v.2)
timeFrame: 6 months
measure: Godin Leisure Time Exercise Questionnaire (GLTEQ)
timeFrame: 6 months
measure: Grip strength measured on hand dynamometer
timeFrame: 6 months
measure: Timed 25-Foot Walk Test
timeFrame: 6 months
measure: Timed Up and Go
timeFrame: 6 months
measure: FIM (R) instrument
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Department of Physical Medicine & Rehabilitation, University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Katherine Knox, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.