Effects of physical activity on cognitive development in children with congenital heart diseases

Physical Activity and Cognitive Development in Children

This study is testing if a structured physical activity program can help improve thinking skills and behavior in children with congenital heart diseases after their heart surgery.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 30 Months to 6 Years
• Sex: All
• Sponsor: Columbia University (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT02542683 on ClinicalTrials.gov

What this trial studies

This observational study compares cognitive functions and physical activity levels between children undergoing cardiac surgery and those undergoing non-cardiac surgery, as well as their healthy siblings or age-matched peers. It aims to assess the impact of a structured physical activity program on cognitive functions and adaptive behavior in children following congenital cardiac surgery over a period of 12 months. The study will also explore whether any cognitive improvements persist beyond the intervention period. By focusing on children with congenital heart diseases, the research seeks to address the neurodevelopmental challenges these patients face as they grow older.

Who should consider this trial

Good fit: Ideal candidates include children aged 30 months or older with congenital cyanotic cardiac diseases scheduled for surgery, as well as age-matched peers undergoing non-cardiac surgery or healthy siblings.

Not a fit: Patients who are younger than 30 months or those with non-cyanotic congenital heart diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive and adaptive outcomes for children with congenital heart diseases through targeted physical activity interventions.

How similar studies have performed: Previous studies have shown positive outcomes from physical activity interventions in improving cognitive functions in children with similar conditions, suggesting potential success for this approach.

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 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)

Where this trial is running

New York, New York

• Columbia University Irving Medical Center / NewYork-Presbyterian Hospital — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Lena S. Sun, MD — Columbia University
• Study coordinator: Lena S. Sun, MD

Conditions: Congenital Heart Diseases, Children, congenital heart diseases, cognition, adaptive behavior, physical activity, neurodevelopment