NCT02990754

Brief 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). 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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

December 6, 2016

Last Update Submit

September 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Habitual Activity Estimation Scale

    Change from baseline in self-reported physical activity participation questionnaire

    1-month post intervention

Study Arms (1)

Intervention Group

EXPERIMENTAL

Individuals attending one or more fearless physical activity events

Behavioral: Physical activity education

Interventions

Instruction in suitable physical activity options and education about physical activity with CHD.

Intervention Group

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • child, adolescent or adult diagnosed with a congenital heart defect and their family members

You may not qualify if:

  • disabilities that prevent the individual from safely participating in group events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Patricia Longmuir, PhD

    Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 13, 2016

Study Start

October 25, 2016

Primary Completion

March 31, 2018

Study Completion

June 30, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations