<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/NCT02990754</url>
  </required_header>
  <id_info>
    <org_study_id>16/106X</org_study_id>
    <nct_id>NCT02990754</nct_id>
  </id_info>
  <brief_title>Fearless Physical Activity: Getting and Keeping Ontarians With Congenital Heart Disease Active</brief_title>
  <acronym>Fearless</acronym>
  <official_title>Fearless Physical Activity: Getting and Keeping Ontarians With Congenital Heart Disease Active in Community Sport, Recreation and Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Eastern Ontario</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Congenital Heart Alliance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Eastern Ontario</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;Fearless Physical Activity&quot; are fun, physical literacy events where people with congenital&#xD;
      heart disease (CHD) and sport/recreation leaders can do community-based sport/recreation&#xD;
      opportunities &quot;without fear&quot; (i.e., appropriate for their health). Ontarians with CHD are a&#xD;
      large and rapidly growing population;1% of children are born with CHD, adding 1,440 new&#xD;
      children/year to the 113,900 Ontarians of all ages who are living with CHD. 'Fearless' will&#xD;
      target CHD children, youth or adults, while encouraging family-based participation. During&#xD;
      each season, the investigators will offer a one-day event for each age group (children,&#xD;
      youth, adults) in each region of Ontario (4 seasons x 3 age groups x 4 regions = 48 events).&#xD;
      Event activities will be hosted by community partners, such as the MLSE Launch Pad (Toronto)&#xD;
      or the YMCA/YWCA of the National Capital Region (Ottawa), so that they are sustainable beyond&#xD;
      this project. Activities will be chosen based on opportunities available in local communities&#xD;
      at little to no cost (e.g., use of local trails and parks). Event leaders and participants&#xD;
      will be educated about physical literacy and screening tasks will be used to identify those&#xD;
      needing significant or specialized physical literacy support. People with CHD lead mostly&#xD;
      sedentary lives. They are much less active than their friends and colleagues, even when their&#xD;
      heart disease is mild, and inactivity can contribute to a higher risk for heart attacks,&#xD;
      stroke, obesity, and depression. Uncertainty about physical activity, even though it is&#xD;
      recommended (American Heart Association, May 2014), is an important barrier to the physical&#xD;
      and mental health benefits of physical activity. &quot;How much is too much?&quot; and &quot;Will it be too&#xD;
      much for my heart?&quot; are top-of-mind. &quot;Fearless Physical Activity&quot; will provide children,&#xD;
      youth and adults living with CHD with new physical activity experiences and opportunities to&#xD;
      enhance their physical literacy so they are better able to be &quot;active for life&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &quot;Fearless Physical Activity&quot; will deliver high-quality, meaningful physical&#xD;
      literacy-enhancing experiences to children, youth and adults with congenital heart disease&#xD;
      (CHD). People with CHD have historically been much less active than other Ontarians,&#xD;
      regardless of heart disease severity. 'Fearless' will increase opportunities for&#xD;
      sport/recreation participation by directly providing 48 days of fun, physical activity&#xD;
      specifically designed for children, youth and adults with CHD and their families. Each event&#xD;
      day, physical literacy screening tasks will identify those with CHD who are likely to require&#xD;
      very significant support to be &quot;active for life&quot;. 'Fearless' participants and leaders will&#xD;
      learn about physical literacy, and it's fundamental role as the foundation of a healthy&#xD;
      active lifestyle. A physical literacy workshop will educate leaders within the Canadian&#xD;
      Congenital Heart Alliance (CCHA) about the importance of physical literacy for people with&#xD;
      CHD and the role that CCHA can play in supporting active lifestyles. Joint organization of&#xD;
      'Fearless' events will develop new partnerships between the CCHA and the community sport and&#xD;
      recreation sector. These partnerships will enhance sport and recreation sector capacity to&#xD;
      understand, and better support, the physical literacy needs of people with CHD. The project&#xD;
      outcomes will be increased physical literacy among children, youth and adults with CHD, more&#xD;
      physically active people with CHD and enhanced sport and recreation sector capacity to&#xD;
      provide opportunities that are accessible to Ontarians with CHD.&#xD;
&#xD;
      The planning and partnership phase of 'Fearless' (April to December 2016) will lay the&#xD;
      groundwork for the delivery of the &quot;Fearless Physical Activity&quot; events. The Project&#xD;
      Coordinator will work collaboratively with the leadership of the Canadian Congenital Heart&#xD;
      Alliance (CCHA) and existing CCHA chapters in London and Eastern Ontario to develop the&#xD;
      educational content and desired physical activity opportunities that will be delivered&#xD;
      through the 'Fearless' events. A previous one-day 'Fearless' event evaluated the feasibility&#xD;
      of our concept and the interest among families of those with CHD. The previous one-day event&#xD;
      combined education sessions about physical activity goal setting, identifying personal&#xD;
      activity interests, and finding community physical activity opportunities with opportunities&#xD;
      to participate in a wide variety of physical activities (e.g., geocaching, Frisbee golf,&#xD;
      croquet, beachball volleyball). Feedback from participating families rated all aspects of the&#xD;
      'Fearless' event as excellent or outstanding. However, this one event was held for children&#xD;
      with CHD and their families during the summer, therefore the project coordinator and project&#xD;
      partners will need to develop additional content and activity plans to ensure that we can&#xD;
      provide events for three age groups (children, youth, adults) and in all four seasons of the&#xD;
      year. Providing events in all four seasons is important because people with CHD are highly&#xD;
      susceptible to temperature extremes (cold, hot) and humidity; leading many people with CHD to&#xD;
      believe that physical activity is not a feasible option at many times of the year. During the&#xD;
      planning phase, the project coordinator will strengthen existing partnerships and networks&#xD;
      within the CCHA and the sport and recreation sector, as well as develop the new partnerships&#xD;
      (recreation/sport partners in western and northern Ontario) and expanded networks (northern&#xD;
      Ontario) needed to ensure that people with CHD know about the Fearless events, which will be&#xD;
      offered in all regions of Ontario.&#xD;
&#xD;
      The 'Fearless' events will be held during 2017 (winter, spring, summer, fall) in each region&#xD;
      of Ontario. Each one-day event will be held on a weekend, to facilitate the participation of&#xD;
      people with CHD and their families. Having a series of education and activity sessions on one&#xD;
      day, rather than shorter sessions held more frequently, will better enable people with CHD to&#xD;
      attend from across the wide geographic areas served by each CCHA chapter / CHD clinic. Each&#xD;
      'Fearless' event will include education sessions, participatory physical activity&#xD;
      opportunities and the completion of physical literacy screening tasks that will identify&#xD;
      those needing the greatest support to be active for life. The topic for one education session&#xD;
      will be physical literacy - its importance, how it can be developed throughout life, and its&#xD;
      relationship to physical and mental health. Each 'Fearless' event will be hosted by a&#xD;
      community sport and recreation partner, enhancing project sustainability and sector capacity&#xD;
      to support the physical activity of people with CHD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2016</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Habitual Activity Estimation Scale</measure>
    <time_frame>1-month post intervention</time_frame>
    <description>Change from baseline in self-reported physical activity participation questionnaire</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals attending one or more fearless physical activity events</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity education</intervention_name>
    <description>Instruction in suitable physical activity options and education about physical activity with CHD.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  child, adolescent or adult diagnosed with a congenital heart defect and their family&#xD;
             members&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  disabilities that prevent the individual from safely participating in group events&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Longmuir, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scientist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Eastern Ontario</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Eastern Ontario</investigator_affiliation>
    <investigator_full_name>Dr. Pat Longmuir</investigator_full_name>
    <investigator_title>Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT02990754
org study id: 16/106X
nct id: NCT02990754
lead sponsor: 
collaborator: 
has dmc: No
"Fearless Physical Activity" are fun, physical literacy events where people with congenital
      heart disease (CHD) and sport/recreation leaders can do community-based sport/recreation
      opportunities "without fear" (i.e., appropriate for their health). Ontarians with CHD are a
      large and rapidly growing population;1% of children are born with CHD, adding 1,440 new
      children/year to the 113,900 Ontarians of all ages who are living with CHD. 'Fearless' will
      target CHD children, youth or adults, while encouraging family-based participation. During
      each season, the investigators will offer a one-day event for each age group (children,
      youth, adults) in each region of Ontario (4 seasons x 3 age groups x 4 regions = 48 events).
      Event activities will be hosted by community partners, such as the MLSE Launch Pad (Toronto)
      or the YMCA/YWCA of the National Capital Region (Ottawa), so that they are sustainable beyond
      this project. Activities will be chosen based on opportunities available in local communities
      at little to no cost (e.g., use of local trails and parks). Event leaders and participants
      will be educated about physical literacy and screening tasks will be used to identify those
      needing significant or specialized physical literacy support. People with CHD lead mostly
      sedentary lives. They are much less active than their friends and colleagues, even when their
      heart disease is mild, and inactivity can contribute to a higher risk for heart attacks,
      stroke, obesity, and depression. Uncertainty about physical activity, even though it is
      recommended (American Heart Association, May 2014), is an important barrier to the physical
      and mental health benefits of physical activity. "How much is too much?" and "Will it be too
      much for my heart?" are top-of-mind. "Fearless Physical Activity" will provide children,
      youth and adults living with CHD with new physical activity experiences and opportunities to
      enhance their physical literacy so they are better able to be "active for life".
"Fearless Physical Activity" will deliver high-quality, meaningful physical
      literacy-enhancing experiences to children, youth and adults with congenital heart disease
      (CHD). People with CHD have historically been much less active than other Ontarians,
      regardless of heart disease severity. 'Fearless' will increase opportunities for
      sport/recreation participation by directly providing 48 days of fun, physical activity
      specifically designed for children, youth and adults with CHD and their families. Each event
      day, physical literacy screening tasks will identify those with CHD who are likely to require
      very significant support to be "active for life". 'Fearless' participants and leaders will
      learn about physical literacy, and it's fundamental role as the foundation of a healthy
      active lifestyle. A physical literacy workshop will educate leaders within the Canadian
      Congenital Heart Alliance (CCHA) about the importance of physical literacy for people with
      CHD and the role that CCHA can play in supporting active lifestyles. Joint organization of
      'Fearless' events will develop new partnerships between the CCHA and the community sport and
      recreation sector. These partnerships will enhance sport and recreation sector capacity to
      understand, and better support, the physical literacy needs of people with CHD. The project
      outcomes will be increased physical literacy among children, youth and adults with CHD, more
      physically active people with CHD and enhanced sport and recreation sector capacity to
      provide opportunities that are accessible to Ontarians with CHD.

      The planning and partnership phase of 'Fearless' (April to December 2016) will lay the
      groundwork for the delivery of the "Fearless Physical Activity" events. The Project
      Coordinator will work collaboratively with the leadership of the Canadian Congenital Heart
      Alliance (CCHA) and existing CCHA chapters in London and Eastern Ontario to develop the
      educational content and desired physical activity opportunities that will be delivered
      through the 'Fearless' events. A previous one-day 'Fearless' event evaluated the feasibility
      of our concept and the interest among families of those with CHD. The previous one-day event
      combined education sessions about physical activity goal setting, identifying personal
      activity interests, and finding community physical activity opportunities with opportunities
      to participate in a wide variety of physical activities (e.g., geocaching, Frisbee golf,
      croquet, beachball volleyball). Feedback from participating families rated all aspects of the
      'Fearless' event as excellent or outstanding. However, this one event was held for children
      with CHD and their families during the summer, therefore the project coordinator and project
      partners will need to develop additional content and activity plans to ensure that we can
      provide events for three age groups (children, youth, adults) and in all four seasons of the
      year. Providing events in all four seasons is important because people with CHD are highly
      susceptible to temperature extremes (cold, hot) and humidity; leading many people with CHD to
      believe that physical activity is not a feasible option at many times of the year. During the
      planning phase, the project coordinator will strengthen existing partnerships and networks
      within the CCHA and the sport and recreation sector, as well as develop the new partnerships
      (recreation/sport partners in western and northern Ontario) and expanded networks (northern
      Ontario) needed to ensure that people with CHD know about the Fearless events, which will be
      offered in all regions of Ontario.

      The 'Fearless' events will be held during 2017 (winter, spring, summer, fall) in each region
      of Ontario. Each one-day event will be held on a weekend, to facilitate the participation of
      people with CHD and their families. Having a series of education and activity sessions on one
      day, rather than shorter sessions held more frequently, will better enable people with CHD to
      attend from across the wide geographic areas served by each CCHA chapter / CHD clinic. Each
      'Fearless' event will include education sessions, participatory physical activity
      opportunities and the completion of physical literacy screening tasks that will identify
      those needing the greatest support to be active for life. The topic for one education session
      will be physical literacy - its importance, how it can be developed throughout life, and its
      relationship to physical and mental health. Each 'Fearless' event will be hosted by a
      community sport and recreation partner, enhancing project sustainability and sector capacity
      to support the physical activity of people with CHD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Habitual Activity Estimation Scale
time frame: 1-month post intervention
description: Change from baseline in self-reported physical activity participation questionnaire
arm group label: Intervention Group
arm group type: Experimental
description: Individuals attending one or more fearless physical activity events
intervention type: Behavioral
intervention name: Physical activity education
description: Instruction in suitable physical activity options and education about physical activity with CHD.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: Patricia Longmuir, PhD
role: Principal Investigator
affiliation: Scientist
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Eastern Ontario
investigator full name: Dr. Pat Longmuir
investigator title: Scientist
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No