Physical Activity and Cognitive Development in Children
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|ClinicalTrials.gov Identifier: NCT02542683|
Recruitment Status : Recruiting
First Posted : September 7, 2015
Last Update Posted : January 31, 2019
- 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.
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment|
|Congenital Heart Diseases Children||Other: structured physical activity program|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Physical Activity and Cognitive Development in Children|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2028|
physical activity program
enrollment for 12 months in a structured physical activity program
Other: structured physical activity program
a structured modest physical activity program
delayed physical activity program
No intervention for 12 months, then enrollment in structured physical activity program
- Intelligence Quotient (IQ) score [ Time Frame: Up to 24 months from the time of assessment at baseline ]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.
- Score on the NIH Toolbox Early Childhood Battery [ Time Frame: Up to 24 months from the time of assessment at baseline ]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.
- Score on Adaptive Behavior Assessment System, 3rd edition (ABAS-III) [ Time Frame: Up to 24 months from the time of assessment at baseline ]Adaptive behavior: Parental reports of behavior using ABAS-III, collected at baseline and then every 6 months up to 24 months later.
- Weight [ Time Frame: Up to 24 months from baseline ]Record weight and plot on growth curve at baseline, then every 6 months for 18 months.
- Height [ Time Frame: Up to 24 months from baseline ]Record height and plot on growth curve at baseline, then every 6 months for 18 months.
Biospecimen Retention: Samples Without DNA
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542683
|Contact: Lena S Sun, MD||2123052413||Lss4@cumc.columbia.edu|
|Contact: Robert A Whittington, MDemail@example.com|
|United States, New York|
|Columbia University, 622 W. 168th St.||Recruiting|
|New York, New York, United States, 10032|
|Contact: Lena Sun, MD 212-305-2413 firstname.lastname@example.org|
|Contact: Robert A Whittington, MD 212-305-3226 email@example.com|
|Principal Investigator: Lena S Sun, MD|
|Principal Investigator:||Lena S Sun, MD||Columbia University|