Recruiting

Physical Activity Program

Sponsor:

Columbia University

Code:

NCT02542683

Conditions

Congenital Heart Diseases

Children

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Accepted

Interventions

structured physical activity program

Study Details

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.

Conditions

Congenital Heart Diseases

Children

Study ID

NCT02542683

Start date

Apr, 2016

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Accepted

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 known chromosomal syndromes, or known syndromes including but not limited to DiGeorge, Trisomy 21, WIlliams, Noonan and Turner.
2. Children with known physical disabilities.
3. Children with known history of central nervous system (CNS) injury including stroke, birth asphyxia, seizure disorder, intraventricular hemorrhage.
4. Children with abnormal neurological exam by a pediatric physician or nurse practitioner, and confirmed by a pediatric neurologist.
5. Children with tricuspid regurgitation on echocardiography or on cardiac angiography that is moderate or greater.
6. Children with moderate or greater decrease in ventricular function on echocardiography or on cardiac angiography.
7. Children with baseline room air oxygen saturation below 80%.
8. Children who are treated for dysrhythmias or are pacemaker-dependent.
9. Children with history of prematurity. (Non-surgical cohort)
10. Children with history of more than one episode of hospitalization. (Non-surgical cohort)

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

physical activity program

enrollment for 12 months in a structured physical activity program

delayed physical activity program

No intervention for 12 months, then enrollment in structured physical activity program

Interventions

structured physical activity program

a structured modest physical activity program

Primary outcome measure

  • Intelligence Quotient (IQ) score [ Time Frame: Up to 24 months from the time of assessment at baseline ]
  • Score on the NIH Toolbox Early Childhood Battery [ Time Frame: Up to 24 months from the time of assessment at baseline ]
  • Score on Adaptive Behavior Assessment System, 3rd edition (ABAS-III) [ Time Frame: Up to 24 months from the time of assessment at baseline ]

Central Contacts and Locations

Central contacts

Lena S. Sun, MD

212-305-2413Lss4@cumc.columbia.edu

Locations

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Lena S. Sun, MD

212-305-2413lss4@cumc.columbia.edu

Robert A. Whittington, MD

212-305-3226raw9@cumc.columbia.edu

Principal Investigator:

Lena S. Sun, MD

More Information

Sponsor

Columbia University

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • congenital heart diseases
  • cognition
  • adaptive behavior
  • physical activity
  • neurodevelopment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-03-04.