Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fearless Physical Activity: Getting and Keeping Ontarians With Congenital Heart Disease Active (Fearless)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990754
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Canadian Congenital Heart Alliance
Information provided by (Responsible Party):
Dr. Pat Longmuir, Children's Hospital of Eastern Ontario

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".

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Behavioral: Physical activity education Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Fearless Physical Activity: Getting and Keeping Ontarians With Congenital Heart Disease Active in Community Sport, Recreation and Physical Activity
Actual Study Start Date : October 25, 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Individuals attending one or more fearless physical activity events
Behavioral: Physical activity education
Instruction in suitable physical activity options and education about physical activity with CHD.




Primary Outcome Measures :
  1. Habitual Activity Estimation Scale [ Time Frame: 1-month post intervention ]
    Change from baseline in self-reported physical activity participation questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990754


Locations
Layout table for location information
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Canadian Congenital Heart Alliance
Investigators
Layout table for investigator information
Principal Investigator: Patricia Longmuir, PhD Scientist
Layout table for additonal information
Responsible Party: Dr. Pat Longmuir, Scientist, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02990754    
Other Study ID Numbers: 16/106X
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities