New York, New York 10032


Purpose:

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.


Study summary:

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.


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)


Study is Available At:


Original ID:

AAAP7626


NCT ID:

NCT02542683


Secondary ID:


Study Acronym:


Brief Title:

Physical Activity and Cognitive Development in Children


Official Title:

Physical Activity and Cognitive Development in Children


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

30 Months


Maximum Age:

6 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Columbia University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Lena S Sun, MD
Principal Investigator
Columbia University
Primary Contact:Lena S Sun, MD
2123052413
Lss4@cumc.columbia.edu
Backup Contact:Robert A Whittington, MD
2123053226
raw9@cumc.columbia.edu

Study Dates

Start Date:April 2016
Completion Date:December 2028
Completion Type:Anticipated
Primary Completion Date:December 2020
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:January 30, 2019
First Received Date:September 3, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Height
Time Frame:Up to 24 months from baseline
Safety Issues:False
Description:Record height and plot on growth curve at baseline, then every 6 months for 18 months.
Outcome Type:Secondary Outcome
Measure:Weight
Time Frame:Up to 24 months from baseline
Safety Issues:False
Description:Record weight and plot on growth curve at baseline, then every 6 months for 18 months.
Outcome Type:Primary Outcome
Measure:Score on Adaptive Behavior Assessment System, 3rd edition (ABAS-III)
Time Frame:Up to 24 months from the time of assessment at baseline
Safety Issues:False
Description:Adaptive behavior: Parental reports of behavior using ABAS-III, collected at baseline and then every 6 months up to 24 months later.
Outcome Type:Primary Outcome
Measure:Score on the NIH Toolbox Early Childhood Battery
Time Frame:Up to 24 months from the time of assessment at baseline
Safety Issues:False
Description: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,
Outcome Type:Primary Outcome
Measure:Intelligence Quotient (IQ) score
Time Frame:Up to 24 months from the time of assessment at baseline
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Other
Name:structured physical activity program
Description:a structured modest physical activity program
Arm Name:physical activity program

Study Arms

Study Arm Type:Other
Arm Name:delayed physical activity program
Description:No intervention for 12 months, then enrollment in structured physical activity program
Study Arm Type:Other
Arm Name:physical activity program
Description:enrollment for 12 months in a structured physical activity program

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Columbia University

Samples and Retentions

Sample Retention:Samples Without DNA
Description: 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
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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