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Completed

NCT Number: NCT03039400

Physiotherapist-guided Home Exercise in Moderate to Severe MS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine & Rehabilitation, University of Saskatchewan

Saskatoon, Saskatchewan, S7K 0M7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Adherence to prescribed exercise program

    Time frame: 6 months

    Measured by number of completed exercise sessions on exercise diary

Secondary outcomes

  1. Injury or fall

    Time frame: 6 months

    Participants will be asked to contact their treating physiotherapist in the event of new pain, injury, or fall.

  2. Multiple Sclerosis Impact Scale (MSIS29 v.2)

    Time frame: 6 months

  3. Godin Leisure Time Exercise Questionnaire (GLTEQ)

    Time frame: 6 months

  4. Grip strength measured on hand dynamometer

    Time frame: 6 months

  5. Timed 25-Foot Walk Test

    Time frame: 6 months

  6. Timed Up and Go

    Time frame: 6 months

  7. FIM (R) instrument

    Time frame: 6 months

    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.

  8. Hospital Anxiety and Depression Scale

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Multiple Sclerosis Society of Canada

Registry information

Official study title

Physiotherapist-guided Home Exercise in Moderate to Severe Multiple Sclerosis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2017
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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