<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/NCT04408287</url>
  </required_header>
  <id_info>
    <org_study_id>115929</org_study_id>
    <nct_id>NCT04408287</nct_id>
  </id_info>
  <brief_title>Improving Activity Engagement Among Persons With SCI During COVID-19</brief_title>
  <official_title>Improving Activity Engagement Among Persons With SCI During COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      During the current COVID-19 pandemic many spinal cord injury (SCI) rehabilitation services&#xD;
      are limited to emergency management, leaving those living in the community without access to&#xD;
      services. Unfortunately, this can lead to negative effects including increase in emotional&#xD;
      distress, feelings of isolation, and decreased activity engagement. Due to their limited&#xD;
      mobility and greater likelihood of respiratory illness it is imperative to provide&#xD;
      alternative forms of activity engagement to reduce their risk for secondary complications.&#xD;
      Physical activity has been demonstrate to have numerous benefits for individuals with SCI&#xD;
      ranging from enhanced health through prevention of secondary complications to improved&#xD;
      subjective well-being. The current study proposes to provide an online physical activity&#xD;
      program through web-based videoconferencing to person with SCI to improve overall wellbeing&#xD;
      and activity engagement. The program will consist of six weeks of twice-weekly, 45-minute&#xD;
      sessions in which an experienced fitness instructor (i.e., wheelchair aerobics) with lived&#xD;
      experience and a Kinesiology graduate student will lead online sessions. The sessions will be&#xD;
      comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down&#xD;
      phase that will incorporate upper-extremity flexibility exercises and guided meditation. In&#xD;
      all cases, remote (i.e., in-home) participant monitoring of physiological signals will be&#xD;
      conducted by the instructor to ensure safety of participants. Once the program has been&#xD;
      completed, participants will be asked to complete self-report questionnaires related to&#xD;
      acceptability, feasibility, and limited effectiveness. Participants will also be asked to&#xD;
      complete a brief semi-structured interview examining barriers and facilitators of the&#xD;
      program. Participant feedback from the interviews will be used to further develop of the&#xD;
      program to meet the needs of the population and develop sustainable approaches for access to&#xD;
      care in the community setting through collaborations with community partners (SCI Ontario,&#xD;
      National SCI Alliance, Ontario Neurotrauma Foundation). Ultimately, the proposed project aims&#xD;
      to improve overall wellbeing and access to health care service for those with SCI during the&#xD;
      COVID-19 quarantine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 28, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The proposed study will deliver an online physical activity program to persons with SCI across Ontario through the WebEx platform at Parkwood Institute. Participants will be recruited from across Ontario through SCI rehabilitation centers and established service providers. Strategic advertising through community partners such as Spinal Cord Injury Ontario, Canadian SCI Alliance and Ontario Neurotrauma Foundation will also be conducted. Study participants will include those with a spinal cord injury that have completed rehabilitation and are living in the community. Participants must have some upper limb function permitting arm movement against gravity. All participants must have physician clearance to participate in the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Satisfaction</measure>
    <time_frame>6 weeks</time_frame>
    <description>Treatment Satisfaction Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ability to Participate in Social Roles and Activities</measure>
    <time_frame>Baseline, 6 weeks, and at 3 month follow-up</time_frame>
    <description>Spinal Cord Injury - Quality of Life Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Baseline, 6 weeks, and at 3 month follow-up</time_frame>
    <description>Spinal Cord Injury - Quality of Life Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Social Roles and Activities</measure>
    <time_frame>Baseline, 6 weeks, and at 3 month follow-up</time_frame>
    <description>Spinal Cord Injury - Quality of Life Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Affect and Well-Being</measure>
    <time_frame>Baseline, 6 weeks, and at 3 month follow-up</time_frame>
    <description>Spinal Cord Injury - Quality of Life Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Interference</measure>
    <time_frame>Baseline, 6 weeks, and at 3 month follow-up</time_frame>
    <description>Spinal Cord Injury - Quality of Life Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>Baseline, 6 weeks, and at 3 month follow-up</time_frame>
    <description>Spinal Cord Injury - Quality of Life Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Esteem</measure>
    <time_frame>Baseline, 6 weeks, and at 3 month follow-up</time_frame>
    <description>Spinal Cord Injury - Quality of Life Short Form</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fear of COVID-19 Scale</measure>
    <time_frame>Baseline, 6 weeks, and at 3 month follow-up</time_frame>
    <description>Fear of COVID-19 Scale</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WebEx Physical Activity Program</intervention_name>
    <description>The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult 18 years or older; living with a spinal cord injury; living in the community in&#xD;
             Ontario; access to a computer and internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not cleared by a physician to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Swati Mehta, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eldon Loh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parkwood Institute, St. Joseph's Health Care London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Swati Mehta, PhD</last_name>
    <phone>5196466100</phone>
    <phone_ext>42359</phone_ext>
    <email>swati.mehta@sjhc.london.on.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daymon D Blackport</last_name>
    <email>daymon.blackport@sjhc.london.on.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. Josephs Parkwood Institute</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6C 5J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Swati Mehta, PhD</last_name>
      <phone>519-646-6100</phone>
      <phone_ext>42359</phone_ext>
      <email>swati.mehta@sjhc.london.on.ca</email>
    </contact>
    <contact_backup>
      <last_name>Daymon D Blackport</last_name>
      <email>daymon.blackport@sjhc.on.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Swati Mehta, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eldon Loh, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dalton Wolfe, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spinal cord injury</keyword>
  <keyword>spinal cord injuries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04408287
org study id: 115929
nct id: NCT04408287
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
During the current COVID-19 pandemic many spinal cord injury (SCI) rehabilitation services
      are limited to emergency management, leaving those living in the community without access to
      services. Unfortunately, this can lead to negative effects including increase in emotional
      distress, feelings of isolation, and decreased activity engagement. Due to their limited
      mobility and greater likelihood of respiratory illness it is imperative to provide
      alternative forms of activity engagement to reduce their risk for secondary complications.
      Physical activity has been demonstrate to have numerous benefits for individuals with SCI
      ranging from enhanced health through prevention of secondary complications to improved
      subjective well-being. The current study proposes to provide an online physical activity
      program through web-based videoconferencing to person with SCI to improve overall wellbeing
      and activity engagement. The program will consist of six weeks of twice-weekly, 45-minute
      sessions in which an experienced fitness instructor (i.e., wheelchair aerobics) with lived
      experience and a Kinesiology graduate student will lead online sessions. The sessions will be
      comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down
      phase that will incorporate upper-extremity flexibility exercises and guided meditation. In
      all cases, remote (i.e., in-home) participant monitoring of physiological signals will be
      conducted by the instructor to ensure safety of participants. Once the program has been
      completed, participants will be asked to complete self-report questionnaires related to
      acceptability, feasibility, and limited effectiveness. Participants will also be asked to
      complete a brief semi-structured interview examining barriers and facilitators of the
      program. Participant feedback from the interviews will be used to further develop of the
      program to meet the needs of the population and develop sustainable approaches for access to
      care in the community setting through collaborations with community partners (SCI Ontario,
      National SCI Alliance, Ontario Neurotrauma Foundation). Ultimately, the proposed project aims
      to improve overall wellbeing and access to health care service for those with SCI during the
      COVID-19 quarantine.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The proposed study will deliver an online physical activity program to persons with SCI across Ontario through the WebEx platform at Parkwood Institute. Participants will be recruited from across Ontario through SCI rehabilitation centers and established service providers. Strategic advertising through community partners such as Spinal Cord Injury Ontario, Canadian SCI Alliance and Ontario Neurotrauma Foundation will also be conducted. Study participants will include those with a spinal cord injury that have completed rehabilitation and are living in the community. Participants must have some upper limb function permitting arm movement against gravity. All participants must have physician clearance to participate in the study.
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment Satisfaction
time frame: 6 weeks
description: Treatment Satisfaction Questionnaire
measure: Ability to Participate in Social Roles and Activities
time frame: Baseline, 6 weeks, and at 3 month follow-up
description: Spinal Cord Injury - Quality of Life Short Form
measure: Fatigue
time frame: Baseline, 6 weeks, and at 3 month follow-up
description: Spinal Cord Injury - Quality of Life Short Form
measure: Satisfaction with Social Roles and Activities
time frame: Baseline, 6 weeks, and at 3 month follow-up
description: Spinal Cord Injury - Quality of Life Short Form
measure: Positive Affect and Well-Being
time frame: Baseline, 6 weeks, and at 3 month follow-up
description: Spinal Cord Injury - Quality of Life Short Form
measure: Pain Interference
time frame: Baseline, 6 weeks, and at 3 month follow-up
description: Spinal Cord Injury - Quality of Life Short Form
measure: Resilience
time frame: Baseline, 6 weeks, and at 3 month follow-up
description: Spinal Cord Injury - Quality of Life Short Form
measure: Self-Esteem
time frame: Baseline, 6 weeks, and at 3 month follow-up
description: Spinal Cord Injury - Quality of Life Short Form
measure: Fear of COVID-19 Scale
time frame: Baseline, 6 weeks, and at 3 month follow-up
description: Fear of COVID-19 Scale
arm group label: Intervention
arm group type: Experimental
description: The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.
intervention type: Other
intervention name: WebEx Physical Activity Program
description: The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Swati Mehta, PhD
role: Principal Investigator
affiliation: Lawson Health Research Institute
last name: Eldon Loh, PhD
role: Principal Investigator
affiliation: Parkwood Institute, St. Joseph's Health Care London
last name: Swati Mehta, PhD
phone: 5196466100
phone ext: 42359
email: swati.mehta@sjhc.london.on.ca
last name: Daymon D Blackport
email: daymon.blackport@sjhc.london.on.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
sharing ipd: No