Congenital Heart DiseaseFearlessNCT02990754
Fearless Physical Activity: Getting and Keeping Ontarians With Congenital Heart Disease Active
A study testing Physical activity education in people with Congenital Heart Disease, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
"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). Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Physical activity education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2016to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- child, adolescent or adult diagnosed with a congenital heart defect and their family members
Who cannot join
- disabilities that prevent the individual from safely participating in group events
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fearless Physical Activity: Getting and Keeping Ontarians With Congenital Heart Disease Active in Community Sport, Recreation and Physical Activity
"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".
Read the detailed description
"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.
- Conditions
- Congenital Heart Disease
- Being tested
- Physical activity education
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity educationBehavioural
Instruction in suitable physical activity options and education about physical activity with CHD.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Individuals attending one or more fearless physical activity events Receives: Behavioral: Physical activity education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Habitual Activity Estimation Scale
Change from baseline in self-reported physical activity participation questionnaire
Measured: 1-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start25 Oct 2016
- Primary completion31 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Congenital Heart Alliance
- Responsible party
- Principal investigator, Dr. Pat Longmuir, Children's Hospital of Eastern Ontario
- Investigators
- Patricia Longmuir, PhD, Principal investigator, Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990754
- Sponsor's protocol ID
- 16/106X
- Acronym
- Fearless
- Status last verified
- Sep 2019
- First submitted
- 6 Dec 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fearless Physical Activity: Getting and Keeping Ontarians With Congenital Heart Disease Active in Community Sport, Recreation and Physical Activity
- ClinicalTrials.gov ID
- NCT02990754
- Acronym / sponsor ID
- Fearless / 16/106X
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Canadian Congenital Heart Alliance
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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".
Detailed description
"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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Physical activity educationIndividuals attending one or more fearless physical activity events |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- child, adolescent or adult diagnosed with a congenital heart defect and their family members
Key exclusion criteria (1 listed)
- disabilities that prevent the individual from safely participating in group events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity educationInstruction in suitable physical activity options and education about physical activity with CHD. | Behavioural | Intervention Group |
Primary outcome
Habitual Activity Estimation Scale
Time frame: 1-month post intervention
Change from baseline in self-reported physical activity participation questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Longmuir, PhD principal investigator
Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity education in people with Congenital Heart Disease, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Habitual Activity Estimation Scale (time frame: 1-month post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.