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
This trial accepts healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
structured physical activity program
Other interventiona structured modest physical activity program
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: physical activity program1 intervention
Group B: delayed physical activity program0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 24 months from the time of assessment at baseline2
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.
Time frame
Up to 24 months from the time of assessment at baseline3
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.
Time frame
Up to 24 months from the time of assessment at baselineSecondary outcomes
1
Weight
Record weight and plot on growth curve at baseline, then every 6 months for 18 months.
Time frame
Up to 24 months from baseline2
Height
Record height and plot on growth curve at baseline, then every 6 months for 18 months.
Time frame
Up to 24 months from baselineSponsors and contacts
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Source ClinicalTrials.gov