xml: <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/NCT06040749</url>
    </required_header>
    <id_info>
      <org_study_id>23-5096</org_study_id>
      <nct_id>NCT06040749</nct_id>
    </id_info>
    <brief_title>Virtual Sport for SCI</brief_title>
    <official_title>Peer-facilitated Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Health Network, Toronto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Health Network, Toronto</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>
        Sport is a physical activity that has many physical, psychological and social benefits for&#xD;
        those with spinal cord injury (SCI). However, most sport research involves people with SCI&#xD;
        who are &lt;50 years old. This is a problem because many people are &gt;50 years old when first&#xD;
        injured. Moreover, people with a SCI are now living longer lives, meaning they also&#xD;
        experience more health challenges. Unfortunately, there is limited research studying the&#xD;
        impact of sport for adults with SCI aged ≥50 years old.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim: To investigate the impact of sport for people with SCI who are ≥50 years old.&#xD;
  &#xD;
        Sport Program: This program will be a trial of virtual handcycling. Fifteen male and five&#xD;
        female volunteers who are ≥50 years old, ≥12 months post-SCI, wheelchair users, and medically&#xD;
        cleared to exercise will be recruited. Five participants will complete the program at a time,&#xD;
        as a group, on Microsoft Teams. The sport program will begin with a physiotherapist virtually&#xD;
        leading 15 minutes of warm-up exercises. Next, a person living with SCI who is aged ≥50 years&#xD;
        old will facilitate 45 minutes of virtual handcycling while screensharing an indoor cycling&#xD;
        application called Zwift, which will provide participants with visual cues and context for&#xD;
        changes in exercise intensity. Participants will be provided a cycle ergometer so they can&#xD;
        participate in their own homes, and with a smart watch so heart rate can be monitored. This&#xD;
        program will run twice a week for three months.&#xD;
  &#xD;
        Outcomes: Data will be collected on physical, psychological, and social health at (1) the&#xD;
        start of the sport program, (2) immediately after, and (3) three months after the program&#xD;
        ends. Any adverse events experienced will be recorded on a survey. Participants' feedback on&#xD;
        the sport program and confidence in staying active will also be assessed using an interview&#xD;
        at the end.&#xD;
  &#xD;
        Conclusion: The knowledge gained will assist in creating future sport programs that may help&#xD;
        address the challenges associated with aging and SCI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 5, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Spinal Cord Independence Measure</measure>
      <time_frame>Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention</time_frame>
      <description>A questionnaire that evaluates the functional abilities of individuals with SCI. This scale consists of three sub-scales that assess areas of function most relevant to SCI: self-care (scored from 0-20), respiration and sphincter management (scored from 0-40), and mobility (scored from 0-40). Final scores for the SCIM range from 0-100, where a higher score indicates greater functional ability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Positive Affect and Well-Being Scale of the Quality of Life in Neurological Disorders Measure (PAWB-Neuro-QoL)</measure>
      <time_frame>Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention</time_frame>
      <description>A questionnaire that assesses affect and sense of well-being. Each statement is to be rated from 1 to 5 (&quot;never&quot; to &quot;always&quot;). The minimum score is 9 and the maximum score is 45. A higher score reflects a greater sense of well-being.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multidimensional Scale of Perceived Social Support</measure>
      <time_frame>Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention</time_frame>
      <description>A questionnaire that evaluates perceived help from a significant other, family, and friends. Each statement is to be rated from 1 to 7 (&quot;very strongly disagree&quot; to &quot;very strongly agree&quot;). The minimum score is 12 and the maximum score is 84. A higher score reflects greater perceived social support.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Moorong Self-Efficacy Scale</measure>
      <time_frame>Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention</time_frame>
      <description>A questionnaire that assesses confidence in performing everyday activities. Each item is scored on a 7-point scale, for a total score out of 112, with a higher score indicating greater self-efficacy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Spinal Cord Injury Exercise Self-Efficacy Scale</measure>
      <time_frame>Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention</time_frame>
      <description>A questionnaire that assesses an individual's confidence in performing various physical activities and exercise. Each statement is scored on a 4-point Likert scale, for a total score out of 40, in which a higher score indicates greater perceived exercise self-efficacy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>6 Minute Push Test</measure>
      <time_frame>Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention</time_frame>
      <description>A field-based assessment that assesses aerobic fitness in manual wheelchair users. During this test, participants will be instructed to propel their wheelchair for 6 minutes along a 30 meter loop while an assessor records the total distanced travelled.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Semi-structured Interview</measure>
      <time_frame>Within 12 weeks after the intervention</time_frame>
      <description>This interview will explore participants' perspectives on a) whether the intervention affected their physical, psychological, and social health, and b) the delivery of the intervention itself (e.g., components, frequency, duration). A semi-structured interview guide informed by the Modified Health through Sport Conceptual Model will be used as a guide.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adverse Events</measure>
      <time_frame>During the 12-week intervention</time_frame>
      <description>Adverse events will be monitored throughout the 12-week intervention. Participants will be asked to complete a survey either online or on paper within 24 hours of experiencing an adverse event. The survey will consist of questions including type, location, and severity. The survey will consist of both closed- and open-ended questions about the circumstances surrounding the adverse event.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Spinal Cord Injury</condition>
    <arm_group>
      <arm_group_label>Virtual group-based handcycling</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Virtual group-based handcycling, twice per week for 12 weeks. Each 60-minute session of the intervention will begin with maximum 15 minutes of PT-led warm-up exercises. Next, a peer-facilitated handcycling session, lasting maximum 45 minutes, will proceed. The handcycling component involves the upper extremities cycling in tandem on a stationary exercise bike. The peer facilitator will be an individual with SCI aged &gt;50 years, who will co-lead participants alongside the PT through brief group discussion, maximum 40 minutes of moderate-vigorous handcycling, and maximum 5 minutes of cool-down.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Virtual group-based handcycling</intervention_name>
      <description>Virtual group-based handcycling</description>
      <arm_group_label>Virtual group-based handcycling</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Sustained a traumatic or non-progressive, non-traumatic SCI,&#xD;
  &#xD;
            2. Chronic stage of recovery (i.e., ≥12 months post-SCI),&#xD;
  &#xD;
            3. ≥50 years old,&#xD;
  &#xD;
            4. Be a manual wheelchair user,&#xD;
  &#xD;
            5. Able to understand spoken English,&#xD;
  &#xD;
            6. Can attend two virtual handcycling sessions/week for 12 weeks and attend on-site&#xD;
               assessments,&#xD;
  &#xD;
            7. Does not intend to change usual physical activity routine throughout duration of the&#xD;
               intervention,&#xD;
  &#xD;
            8. Be cleared to participate in exercise (determined through completion of the 2022&#xD;
               Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)58),&#xD;
  &#xD;
            9. Able to secure hands on handlebars with or without assistance during at-home sessions,&#xD;
  &#xD;
           10. Has one emergency contact who can be promptly reached at any point during the&#xD;
               intervention,&#xD;
  &#xD;
           11. Can independently perform easy-moderate revolutions of arm ergometry movement for ≥10&#xD;
               minutes, with or without adaptations to secure the hands on the handlebars, and&#xD;
  &#xD;
           12. Can independently bring up at least one hand to wave at shoulder level.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Present with significant shoulder pain that reduces use of upper limbs,&#xD;
  &#xD;
            2. Present with condition(s) other than SCI that affect ability to use upper limbs or&#xD;
               follow English instructions,&#xD;
  &#xD;
            3. Have a pressure injury (&gt;grade 2) on the pelvis, sacrum, or hand(s), or&#xD;
  &#xD;
            4. Experienced major trauma or surgery within the last 6 months&#xD;
  &#xD;
            5. Have a history of cardiovascular disease (myocardial infarction, stroke,&#xD;
               hyperlipidemia or untreated hypertension) and do not receive physician clearance to&#xD;
               participate.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kristin E Musselman, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Health Network, Toronto</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kristin E Musselman, PhD</last_name>
      <phone>416-597-3422</phone>
      <phone_ext>6190</phone_ext>
      <email>kristin.musselman@uhn.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>KITE-Toronto Rehabilitation Institute, UHN</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kristin Musselman, PhD</last_name>
        <phone>(416) 597-3422</phone>
        <phone_ext>6190</phone_ext>
        <email>kristin.musselman@uhn.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
      <investigator_full_name>Kristin Musselman</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Virtual sport</keyword>
    <keyword>Sport</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>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040749
  org study id: 23-5096
  nct id: NCT06040749
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Sport is a physical activity that has many physical, psychological and social benefits for
        those with spinal cord injury (SCI). However, most sport research involves people with SCI
        who are <50 years old. This is a problem because many people are >50 years old when first
        injured. Moreover, people with a SCI are now living longer lives, meaning they also
        experience more health challenges. Unfortunately, there is limited research studying the
        impact of sport for adults with SCI aged ≥50 years old.
  Aim: To investigate the impact of sport for people with SCI who are ≥50 years old.
  
        Sport Program: This program will be a trial of virtual handcycling. Fifteen male and five
        female volunteers who are ≥50 years old, ≥12 months post-SCI, wheelchair users, and medically
        cleared to exercise will be recruited. Five participants will complete the program at a time,
        as a group, on Microsoft Teams. The sport program will begin with a physiotherapist virtually
        leading 15 minutes of warm-up exercises. Next, a person living with SCI who is aged ≥50 years
        old will facilitate 45 minutes of virtual handcycling while screensharing an indoor cycling
        application called Zwift, which will provide participants with visual cues and context for
        changes in exercise intensity. Participants will be provided a cycle ergometer so they can
        participate in their own homes, and with a smart watch so heart rate can be monitored. This
        program will run twice a week for three months.
  
        Outcomes: Data will be collected on physical, psychological, and social health at (1) the
        start of the sport program, (2) immediately after, and (3) three months after the program
        ends. Any adverse events experienced will be recorded on a survey. Participants' feedback on
        the sport program and confidence in staying active will also be assessed using an interview
        at the end.
  
        Conclusion: The knowledge gained will assist in creating future sport programs that may help
        address the challenges associated with aging and SCI.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Spinal Cord Independence Measure
  time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
  description: A questionnaire that evaluates the functional abilities of individuals with SCI. This scale consists of three sub-scales that assess areas of function most relevant to SCI: self-care (scored from 0-20), respiration and sphincter management (scored from 0-40), and mobility (scored from 0-40). Final scores for the SCIM range from 0-100, where a higher score indicates greater functional ability.
  measure: Positive Affect and Well-Being Scale of the Quality of Life in Neurological Disorders Measure (PAWB-Neuro-QoL)
  time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
  description: A questionnaire that assesses affect and sense of well-being. Each statement is to be rated from 1 to 5 ("never" to "always"). The minimum score is 9 and the maximum score is 45. A higher score reflects a greater sense of well-being.
  measure: Multidimensional Scale of Perceived Social Support
  time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
  description: A questionnaire that evaluates perceived help from a significant other, family, and friends. Each statement is to be rated from 1 to 7 ("very strongly disagree" to "very strongly agree"). The minimum score is 12 and the maximum score is 84. A higher score reflects greater perceived social support.
  measure: Moorong Self-Efficacy Scale
  time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
  description: A questionnaire that assesses confidence in performing everyday activities. Each item is scored on a 7-point scale, for a total score out of 112, with a higher score indicating greater self-efficacy.
  measure: Spinal Cord Injury Exercise Self-Efficacy Scale
  time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
  description: A questionnaire that assesses an individual's confidence in performing various physical activities and exercise. Each statement is scored on a 4-point Likert scale, for a total score out of 40, in which a higher score indicates greater perceived exercise self-efficacy.
  measure: 6 Minute Push Test
  time frame: Change from baseline to immediately after the intervention to a 12-week follow-up after the intervention
  description: A field-based assessment that assesses aerobic fitness in manual wheelchair users. During this test, participants will be instructed to propel their wheelchair for 6 minutes along a 30 meter loop while an assessor records the total distanced travelled.
  measure: Semi-structured Interview
  time frame: Within 12 weeks after the intervention
  description: This interview will explore participants' perspectives on a) whether the intervention affected their physical, psychological, and social health, and b) the delivery of the intervention itself (e.g., components, frequency, duration). A semi-structured interview guide informed by the Modified Health through Sport Conceptual Model will be used as a guide.
  measure: Adverse Events
  time frame: During the 12-week intervention
  description: Adverse events will be monitored throughout the 12-week intervention. Participants will be asked to complete a survey either online or on paper within 24 hours of experiencing an adverse event. The survey will consist of questions including type, location, and severity. The survey will consist of both closed- and open-ended questions about the circumstances surrounding the adverse event.
  arm group label: Virtual group-based handcycling
  arm group type: Experimental
  description: Virtual group-based handcycling, twice per week for 12 weeks. Each 60-minute session of the intervention will begin with maximum 15 minutes of PT-led warm-up exercises. Next, a peer-facilitated handcycling session, lasting maximum 45 minutes, will proceed. The handcycling component involves the upper extremities cycling in tandem on a stationary exercise bike. The peer facilitator will be an individual with SCI aged >50 years, who will co-lead participants alongside the PT through brief group discussion, maximum 40 minutes of moderate-vigorous handcycling, and maximum 5 minutes of cool-down.
  intervention type: Other
  intervention name: Virtual group-based handcycling
  description: Virtual group-based handcycling
  arm group label: Virtual group-based handcycling
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kristin E Musselman, PhD
  role: Principal Investigator
  affiliation: University Health Network, Toronto
  last name: Kristin E Musselman, PhD
  phone: 416-597-3422
  phone ext: 6190
  email: kristin.musselman@uhn.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University Health Network, Toronto
  investigator full name: Kristin Musselman
  investigator title: Principal Investigator
  mesh term: Spinal Cord Injuries
  sharing ipd: Undecided