<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03039400</url>
  </required_header>
  <id_info>
    <org_study_id>Bio 16-280</org_study_id>
    <nct_id>NCT03039400</nct_id>
  </id_info>
  <brief_title>Physiotherapist-guided Home Exercise in Moderate to Severe MS</brief_title>
  <official_title>Physiotherapist-guided Home Exercise in Moderate to Severe Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Multiple Sclerosis Society of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Saskatchewan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physical activity is a crucial component to wellness and is associated with multiple health&#xD;
      benefits. Persons with MS may find it challenging to participate in regular physical activity&#xD;
      or exercise, which is activity done to improve health and/or fitness. This research will test&#xD;
      an innovative web-based intervention to help persons with moderate-to-severe disability&#xD;
      manage their condition through a maintenance exercise program with specialized&#xD;
      physiotherapist guidance and support. The researchers will examine adherence to the web-based&#xD;
      physiotherapy program compared to standard physiotherapy care. Forty-five people with MS will&#xD;
      be randomly assigned to the web group or standard care group at a rate of 2:1. Participants&#xD;
      in the web group will receive supported and individualized web-based physiotherapy.&#xD;
      Participants in the standard care group will receive a written exercise program. Regular&#xD;
      participation (adherence) in the exercise programs will be evaluated in both groups over six&#xD;
      months. The research will also examine participant satisfaction with the programs, safety, MS&#xD;
      symptoms, and physical function. A web-based approach may be widely accessible to persons&#xD;
      with MS in their own homes and could support long-term participation in physical activity&#xD;
      important to wellness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">October 11, 2018</completion_date>
  <primary_completion_date type="Actual">October 11, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to prescribed exercise program</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by number of completed exercise sessions on exercise diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Injury or fall</measure>
    <time_frame>6 months</time_frame>
    <description>Participants will be asked to contact their treating physiotherapist in the event of new pain, injury, or fall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Sclerosis Impact Scale (MSIS29 v.2)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Godin Leisure Time Exercise Questionnaire (GLTEQ)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength measured on hand dynamometer</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed 25-Foot Walk Test</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FIM (R) instrument</measure>
    <time_frame>6 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Web-based physio group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physiotherapist-guided home exercise with web-based support</intervention_name>
    <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.</description>
    <arm_group_label>Web-based physio group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physiotherapist-guided home exercise with standard support</intervention_name>
    <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.</description>
    <arm_group_label>Standard care group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with MS&#xD;
&#xD;
          -  moderate to severe disability (PDDS 2-7)&#xD;
&#xD;
          -  able to access the internet in your current living environment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  already doing structured exercise more than once per week&#xD;
&#xD;
          -  residing &gt;300km from Saskatoon (unless able to travel to Saskatoon for the&#xD;
             appointments)&#xD;
&#xD;
          -  unable to understand the intent and process of this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Knox, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Physical Medicine &amp; Rehabilitation, University of Saskatchewan</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7K 0M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <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>
    <PMID>33177956</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>April 7, 2021</last_update_submitted>
  <last_update_submitted_qc>April 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Katherine Knox</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03039400
org study id: Bio 16-280
nct id: NCT03039400
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Adherence to prescribed exercise program
time frame: 6 months
description: Measured by number of completed exercise sessions on exercise diary
measure: Injury or fall
time frame: 6 months
description: Participants will be asked to contact their treating physiotherapist in the event of new pain, injury, or fall.
measure: Multiple Sclerosis Impact Scale (MSIS29 v.2)
time frame: 6 months
measure: Godin Leisure Time Exercise Questionnaire (GLTEQ)
time frame: 6 months
measure: Grip strength measured on hand dynamometer
time frame: 6 months
measure: Timed 25-Foot Walk Test
time frame: 6 months
measure: Timed Up and Go
time frame: 6 months
measure: FIM (R) instrument
time frame: 6 months
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.
measure: Hospital Anxiety and Depression Scale
time frame: 6 months
arm group label: Web-based physio group
arm group type: Experimental
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 group label: Standard care group
arm group type: Active Comparator
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: Physiotherapist-guided home exercise with web-based support
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.
arm group label: Web-based physio group
intervention type: Behavioral
intervention name: Physiotherapist-guided home exercise with standard support
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.
arm group label: Standard care group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katherine Knox, MD
role: Principal Investigator
affiliation: University of Saskatchewan
facility: 
country: Canada
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.
PMID: 33177956
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Katherine Knox
investigator title: Associate Professor
mesh term: Multiple Sclerosis
mesh term: Sclerosis