Physical Activity and Cognitive Development in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-6
SponsorColumbia University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Sibling of children of CHD patients within 12 months in age, and 30 months of age or older.
Relatives of CHD patients of the same gender within 12 months in age and 30 months of age or older.
Disqualifiers
Children with known chromosomal syndromes, or known syndromes including but not limited to DiGeorge, Trisomy 21, WIlliams, Noonan and Turner.
Children with known physical disabilities.
Children with known history of central nervous system (CNS) injury including stroke, birth asphyxia, seizure disorder, intraventricular hemorrhage.
Children with abnormal neurological exam by a pediatric physician or nurse practitioner, and confirmed by a pediatric neurologist.
Trial design
Treatments tested in this trial
- structured physical activity program
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov