Physical Activity and Cognitive Development in Children with Congenital Heart Disease
This observational study is looking at how physical activity affects the brain development of children with congenital heart diseases (heart problems present at birth). Researchers want to compare the physical activity levels and thinking skills of children who have heart surgery with children having other types of surgery, and with healthy children. They also want to see if a structured physical activity program helps improve thinking skills and daily living abilities in children after heart surgery. The study will measure intelligence (IQ score), early childhood development, and adaptive behavior (skills needed for daily life) up to 24 months after the initial assessment. Children between 30 months and 6 years old with congenital heart disease or those undergoing non-cardiac surgery can participate. The study aims to enroll 300 children.
- Study design
- This is an observational study, meaning researchers will watch and record information without giving specific treatments to all participants. It aims to enroll 300 children.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 24 months from their initial assessment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Physical Activity and Cognitive Development in Children
At a glance
Conditions
NCT02542683
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Lena S. Sun, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
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Inclusion
What this trial measures
- Intelligence Quotient (IQ) scoreUp to 24 months from the time of assessment at baseline
Global neurocognitive function assessment with IQ score using the Wechsler Preschool and Primary Scale of Intelligence (WPPSI 4): at baseline and up to 24 months later.
- Score on the NIH Toolbox Early Childhood BatteryUp to 24 months from the time of assessment at baseline
Domain-specific neurocognitive function: Memory, learning, attention, executive function, language and motor function using the NIH Toolbox Early Childhood. Scores from each domain in the battery will be used . Domain-specific scores obtained at baseline, then every 6 months up to 24 months later.
- Score on Adaptive Behavior Assessment System, 3rd edition (ABAS-III)Up to 24 months from the time of assessment at baseline
Adaptive behavior: Parental reports of behavior using ABAS-III, collected at baseline and then every 6 months up to 24 months later.