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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Canada1 site
  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

Other trials in Canada

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.

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 groups in NCT02990754
Study groupRoleWhat they receive
Intervention GroupExperimentalIndividuals 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.

  1. 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.

  1. First posted13 Dec 2016 (estimated)
  2. Study start25 Oct 2016
  3. Primary completion31 Mar 2018
  4. Study completion30 Jun 2018

Resources

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)
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

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.

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