Actively Recruiting

Age: 30Months - 6Years
All Genders
Healthy Volunteers
NCT02542683

Physical Activity and Cognitive Development in Children

Led by Columbia University · Updated on 2026-03-04

300

Participants Needed

1

Research Sites

661 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Physical Activity and Cognitive Development in Children

Who Can Participate

Age: 30Months - 6Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with congenital cyanotic cardiac diseases scheduled for cardiac surgery who are older than 30 months
  • Children aged 30 months or older undergoing non-cardiac surgery including general, urological, ENT, plastic, or eye surgery
  • Siblings of children with congenital heart disease within 12 months of age and 30 months or older
  • Relatives of congenital heart disease patients of the same gender within 12 months of age and 30 months or older
  • Best buddies of congenital heart disease children within 12 months of age and 30 months or older
  • Children matched by age (±6 months), gender, parental education, and home language who are 30 months or older
Not Eligible

You will not qualify if you...

  • Children with known chromosomal syndromes such as DiGeorge, Trisomy 21, Williams, Noonan, or Turner
  • Children with known physical disabilities
  • Children with history of central nervous system injury including stroke, birth asphyxia, seizure disorder, or intraventricular hemorrhage
  • Children with abnormal neurological exam confirmed by pediatric neurologist
  • Children with moderate or greater tricuspid regurgitation on echocardiography or cardiac angiography
  • Children with moderate or greater decrease in ventricular function on echocardiography or cardiac angiography
  • Children with baseline room air oxygen saturation below 80%
  • Children treated for dysrhythmias or who are pacemaker-dependent
  • Children with history of prematurity (non-surgical cohort)
  • Children with history of more than one hospitalization (non-surgical cohort)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, United States, 10032

Actively Recruiting

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Research Team

L

Lena S. Sun, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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