RECRUITING

Physical Activity and Cognitive Development in Children

Conditions

Congenital Heart Diseases Children cognition adaptive behavior physical activity neurodevelopment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Physical Activity and Cognitive Development in Children

Quick Facts

Study Start:2016-04

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02542683

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Months to 6 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	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)

Inclusion Criteria

Exclusion 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

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)

Contacts and Locations

Study Contact

Lena S. Sun, MD

CONTACT

212-305-2413

Lss4@cumc.columbia.edu

Principal Investigator

Lena S. Sun, MD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

Lena S. Sun, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-04

Study Completion Date2028-12

Study Record Updates

Study Start Date2016-04

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

congenital heart diseases
cognition
adaptive behavior
physical activity
neurodevelopment

Additional Relevant MeSH Terms

Congenital Heart Diseases
Children