Physical Activity and Cognitive Development in Children

Children Clinical Trial

Official title:

Physical Activity and Cognitive Development in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02542683
• Other study ID #: AAAP7626
• Status: Recruiting
• Start date: April 2016
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: Lena S. Sun, MD
• Phone: 212-305-2413
• Email: Lss4[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Mortality associated with congenital heart defects (CHD) has decreased significantly world-wide over the past decades. As more CHD patients are surviving beyond infancy and childhood, these patients are found to be at significant risk for developmental disabilities and developmental delay. In CHD patients, their neurodevelopmental impairments, as suggested by recent data from the Boston Circulatory Arrest Trial, appear to become more serious with increasing age. As they mature into adolescents and adults, more areas of neurocognitive abnormalities become evident. These abnormalities significantly influence their ability to function independently in their daily living and impact their quality of life. Physical activity has been shown to improve cognitive function in adults and improve attentional inhibition and cognitive flexibility in school-age children between 7 to 9 years of age. An exercise program has also been shown to improve self-reported cognitive functioning and parent-reported social functioning in older children and adolescents (age 10-25 years) with Tetralogy of Fallot or single ventricle physiology. Of note, neuroimaging studies have further documented that physical activity induces an increase in hippocampal volume which corresponds to the observed improvement in memory tasks. Since neurocognitive functions in CHD patients become worse as they get older, any early intervention that can mitigate the neurocognitive impairment in these patients will modify their negative neurodevelopmental trajectory and thus could have a major impact on the mental and cognitive well-being of CHD patients. The purpose of our study is to test the hypothesis that a regular, structured physical activity program as recommended by the American Heart Association will improve cognitive function and adaptive behavior in children with CHD after cardiac surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Months to 6 Years

Eligibility

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)

Related Conditions & MeSH terms

• Children
• Congenital Heart Diseases
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• structured physical activity program
a structured modest physical activity program

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center / NewYork-Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Weight	Record weight and plot on growth curve at baseline, then every 6 months for 18 months.	Up to 24 months from baseline
Secondary	Height	Record height and plot on growth curve at baseline, then every 6 months for 18 months.	Up to 24 months from baseline