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Recruiting NCT02542683

Physical Activity and Cognitive Development in Children

Trial Parameters

Condition Congenital Heart Diseases
Sponsor Columbia University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 300
Sex ALL
Min Age 30 Months
Max Age 6 Years
Start Date 2016-04
Completion 2027-12
Interventions
structured physical activity program

Brief Summary

1. Compare physical activity and cognitive functions between children having cardiac surgery with an age-matched group of children undergoing non-cardiac surgery, as well as otherwise healthy siblings or best buddies (or age and gender-matched children if no siblings or best buddies available) before surgery and after surgery or six months following initial assessment. 2. Determine the effects of a structured physical activity program for 6 months following surgery on cognitive functions and adaptive behavior in children following congenital cardiac surgery. 3. Determine the effects of a structured physical activity program for 12 months following surgery on cognitive functions and adaptive behavior in children following congenital cardiac surgery. 4. We will perform exploratory analysis to determine whether any effects of a 12-months structured physical activity program on cognitive functions and adaptive behavior persist beyond 12 months after cessation of the program.

Eligibility Criteria

Inclusion Criteria: * Congenital Heart Diseases (CHD) Cohort: All children with congenital cyanotic cardiac diseases scheduled for congenital cardiac surgery who are older than 30 months of age. * Non-CHD, Surgical Cohort: All children 30 months or older who are undergoing non-cardiac surgery at Columbia University Medical Center (CUMC), including pediatric general surgery, urological surgery, ear, nose and throat (ENT) surgery, plastic surgery and eye surgery. These children will be recruited before surgery. * Non-surgical cohort: 1. Sibling of children of CHD patients within 12 months in age, and 30 months of age or older. 2. Relatives of CHD patients of the same gender within 12 months in age and 30 months of age or older. 3. Best buddies of CHD children within 12 months in age and 30 months of age or older. 4. Children who are matched by age ±6 months who are 30 months of age or older, gender, level parental education and language spoken at home Exclusion Criteria: 1. Children with

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