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Physiotherapist-guided Home Exercise in Moderate to Severe MS

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physiotherapist-guided home exercise with web-based support
Physiotherapist-guided home exercise with standard support
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Medicine & Rehabilitation, University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Web-based physio group

Standard care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adherence to prescribed exercise program
Measured by number of completed exercise sessions on exercise diary

Secondary Outcome Measures

Injury or fall
Participants will be asked to contact their treating physiotherapist in the event of new pain, injury, or fall.
Multiple Sclerosis Impact Scale (MSIS29 v.2)
Godin Leisure Time Exercise Questionnaire (GLTEQ)
Grip strength measured on hand dynamometer
Timed 25-Foot Walk Test
Timed Up and Go
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.
Hospital Anxiety and Depression Scale

Full Information

First Posted
December 20, 2016
Last Updated
April 7, 2021
Sponsor
University of Saskatchewan
Collaborators
Multiple Sclerosis Society of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03039400
Brief Title
Physiotherapist-guided Home Exercise in Moderate to Severe MS
Official Title
Physiotherapist-guided Home Exercise in Moderate to Severe Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
October 11, 2018 (Actual)
Study Completion Date
October 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Multiple Sclerosis Society of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-based physio group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapist-guided home exercise with web-based support
Intervention Description
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
Intervention Name(s)
Physiotherapist-guided home exercise with standard support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to prescribed exercise program
Description
Measured by number of completed exercise sessions on exercise diary
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Injury or fall
Description
Participants will be asked to contact their treating physiotherapist in the event of new pain, injury, or fall.
Time Frame
6 months
Title
Multiple Sclerosis Impact Scale (MSIS29 v.2)
Time Frame
6 months
Title
Godin Leisure Time Exercise Questionnaire (GLTEQ)
Time Frame
6 months
Title
Grip strength measured on hand dynamometer
Time Frame
6 months
Title
Timed 25-Foot Walk Test
Time Frame
6 months
Title
Timed Up and Go
Time Frame
6 months
Title
FIM (R) instrument
Description
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.
Time Frame
6 months
Title
Hospital Anxiety and Depression Scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Knox, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine & Rehabilitation, University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0M7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33177956
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.
Results Reference
result
PubMed Identifier
35341443
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.
Results Reference
derived

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Physiotherapist-guided Home Exercise in Moderate to Severe MS

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