Enhanced Physical Activity Support in Congenital Heart Disease Clinical Care

NCT03435354 | Completed

• 1 other identifier: 17/191X
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 3

Brief Summary

Our cluster randomized controlled trial of a novel clinical practice change will IMPACT the physical activity (PA) of children living with congenital heart defects (CHD) through our Innovative and pragmatic approach to systematically incorporate PA counselling within each clinic visit. Long-term, the focus is to prevent or treat the most common secondary morbidities of these patients (atherosclerosis, anxiety, depression) through enhanced PA. We have previously shown that home-based, PA interventions can increase daily PA and enhance PA motivation, motor skill and fitness when delivered via an intensive research intervention. Our objectives for this study are to Measure the feasibility and efficacy of PA counselling using clinical resources among paediatric CHD patients (daily PA, PA motivation, competence, quality of life) and on clinic systems (% patients counselled, clinic/kinesiology personnel support required, clinic visit time, # of PA questions). Our Patient-empowering, ready-to-use, self-explanatory "tool kit" of clinician PA resources and patient/family/clinician friendly searchable electronic PA database will be used to promote the Active lifestyles that are critically important to physical/mental health, peer socialization \& childhood growth/development. 90% of children are not active enough for optimal health. We initially target children with CHD because they are less active than peers, and their most important secondary morbidities can be prevented or treated through PA. Our Collaborative approach with patients, their families and leaders in paediatric cardiac healthcare will optimize our "PA tool kit" and novel practice change for Translation to all paediatric CHD healthcare systems (primary, secondary, tertiary) through our pan-Canadian Cardiac Kids Quality of LIFFE Research and Knowledge Exchange Network, a collaborative of 10 patient/family support networks and 10 paediatric cardiac clinics in 6 provinces focused on Learning, Independence, Friends, Fitness \& Emotional health (LIFFE).

Conditions

Congenital Heart Disease

Keywords

Physical activity; Quality of life; Activity motivation; Children; Adolescents; Cluster-randomized trial

Outcome Measures

Primary Outcomes (1)

• Change in daily physical activity

  Pedometer step counts per day

  Baseline then first week of each month for 6 months

Secondary Outcomes (3)

• Change in physical activity adequacy and predilection

  Baseline, 6 months

• Change in quality of life

  Baseline, 6 months

• Change in physical literacy

  Baseline, 6 months

Other Outcomes (4)

• Clinic visit time

  Baseline

• Number of PA encounters

  Through study completion on average 6 months

• Delivery of PA counselling

  Through study completion, on average 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Physical activity counselling during cardiac clinic visit with additional supports for community physical activity and access to a kinesiologist.

Behavioral: Physical activity counselling

Usual Care

NO INTERVENTION

Cardiac clinic visit with usual care but no physical activity counselling

Interventions

Physical activity counselling BEHAVIORAL

Clinician counselling about physical activity using standardized tools to promote daily physical activity.

Also known as: PA counselling

Intervention

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients 5 to 17 years with CHD diagnoses classified as moderate or severe in complexity by the American College of Cardiology / American Heart Association joint guidelines.

You may not qualify if:

• Cardiac intervention (catheterization or surgery) in preceding 6 months. Syndrome/diagnosis affecting physical activity (e.g., developmental disability) or the ability to complete the assessment questionnaires.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• Stollery Children's Hospital: collaborator
• London Health Sciences Centre: collaborator
• CHEO Family Forum: collaborator
• Canadian Congenital Heart Alliance: collaborator
• Ontario Child Health Support Unit: collaborator

Study Sites (3)

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (1)

• Longmuir PE, Lougheed J, Mackie AS, Norozi K, Yaraskavitch J, Chappell A, Dempsey A, Blais A, Foshaug R, Willan A, Graham J. In-Clinic Activity Promotion for Children With Congenital Heart Disease: Randomized Clinical Trial. CJC Pediatr Congenit Heart Dis. 2025 Feb 5;4(3):150-159. doi: 10.1016/j.cjcpc.2025.01.003. eCollection 2025 Jun.

  PMID: 40933783 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Patricia Longmuir, PhD

  Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Those conducting the post-intervention assessments will be blind to study group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist, Assistant Professor

Model Details: Cluster-randomized trial, with randomization by within each site by week (i.e., site-week)

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 19, 2018
• Study Start: March 5, 2018
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CA (3)