Physical Activity and Cognitive Development in Children



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 6
Updated:2/2/2019
Start Date:April 2016
End Date:December 2028
Contact:Lena S Sun, MD
Email:Lss4@cumc.columbia.edu
Phone:2123052413

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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.

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.

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)
We found this trial at
1
site
New York, New York 10032
Principal Investigator: Lena S Sun, MD
Phone: 212-305-2413
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mi
from
New York, NY
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