Physical Activity and Cognitive Development in Children

NCT02542683 | Recruiting

• 1 other identifier: AAAP7626
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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. 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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Intelligence Quotient (IQ) score

  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.

  Up to 24 months from the time of assessment at baseline

• Score on the NIH Toolbox Early Childhood Battery

  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.

  Up to 24 months from the time of assessment at baseline

• Score on Adaptive Behavior Assessment System, 3rd edition (ABAS-III)

  Adaptive behavior: Parental reports of behavior using ABAS-III, collected at baseline and then every 6 months up to 24 months later.

  Up to 24 months from the time of assessment at baseline

Secondary Outcomes (2)

• Weight

  Up to 24 months from baseline

• Height

  Up to 24 months from baseline

Study Arms (2)

physical activity program

enrollment for 12 months in a structured physical activity program

Other: 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 OTHER

a structured modest physical activity program

physical activity program

Eligibility Criteria

• Age: 30 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Physicians or nurse practitioner who are providers of care for CHD patients from the pediatric cardiology and/or cardiothoracic surgical services will make initial contact with parents of potential study subjects regarding enrollment in the study.

You may qualify if:

• 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:
• Sibling of children of CHD patients within 12 months in age, and 30 months of age or older.
• Relatives of CHD patients of the same gender within 12 months in age and 30 months of age or older.
• Best buddies of CHD children within 12 months in age and 30 months of age or older.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Because the blood sampling will only be performed when the study subject will be having his or her routine blood tests either as a part of preoperative testing, or as follow up for his or her clinical condition, there will be no additional discomfort or problems associated with the blood draw. The amount of blood we will be asking for the study is approximately 5 ml, of about one teaspoonful. We will test for the following: cytokine panel (Tumor necrosis factor(TNF-alpha), Interleukins (IL-1ß, IL-6, IL-8), CRP and other relevant biomarkers as indicated

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

• Lena S. Sun, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena S. Sun, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: E.M. Papper Professor of Pediatric Anesthesiology

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: April 1, 2016
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)