Physical Activity and Cognitive Development in Children

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT02542683
Status
Recruiting
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Conditions

  • Children
  • Congenital Heart Diseases

Eligibility Criteria

Sex
ALL
Age
30 Months - 6 Years
Healthy Volunteers
Accepted

Interventions

  • structured physical activity program — OTHER
    a structured modest physical activity program

Study Details

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.

Key Dates

Start date
Apr 30, 2016
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: physical activity program
    enrollment for 12 months in a structured physical activity program
  • Arm: delayed physical activity program
    No intervention for 12 months, then enrollment in structured physical activity program

Primary Outcome Measure

Intelligence Quotient (IQ) score [ Time Frame: Up to 24 months from the time of assessment at baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center / NewYork-Presbyterian HospitalNew YorkNew York10032
Lena S. Sun, MD
[email protected]
212-305-2413
Robert A. Whittington, MD
[email protected]
212-305-3226
Lena S. Sun, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital· New York, NY

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