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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
Sponsor:
Information provided by (Responsible Party):
Lena S. Sun, Columbia University

Brief Summary:
  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.

Condition or disease Intervention/treatment
Congenital Heart Diseases Children Other: structured physical activity program

Detailed Description:
Mortality associated with congenital heart defects (CHD) has decreased significantly world-wide over the past decades. As more CHD patients are surviving beyond infancy and childhood, these patients are found to be at significant risk for developmental disabilities and developmental delay. In CHD patients, their neurodevelopmental impairments, as suggested by recent data from the Boston Circulatory Arrest Trial, appear to become more serious with increasing age. As they mature into adolescents and adults, more areas of neurocognitive abnormalities become evident. These abnormalities significantly influence their ability to function independently in their daily living and impact their quality of life. Physical activity has been shown to improve cognitive function in adults and improve attentional inhibition and cognitive flexibility in school-age children between 7 to 9 years of age. An exercise program has also been shown to improve self-reported cognitive functioning and parent-reported social functioning in older children and adolescents (age 10-25 years) with Tetralogy of Fallot or single ventricle physiology. Of note, neuroimaging studies have further documented that physical activity induces an increase in hippocampal volume which corresponds to the observed improvement in memory tasks. Since neurocognitive functions in CHD patients become worse as they get older, any early intervention that can mitigate the neurocognitive impairment in these patients will modify their negative neurodevelopmental trajectory and thus could have a major impact on the mental and cognitive well-being of CHD patients. The purpose of our study is to test the hypothesis that a regular, structured physical activity program as recommended by the American Heart Association will improve cognitive function and adaptive behavior in children with CHD after cardiac surgery.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   30 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

Inclusion 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

Exclusion Criteria:

  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)

Information from the National Library of Medicine

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


Contacts
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Contact: Lena S Sun, MD 2123052413 Lss4@cumc.columbia.edu
Contact: Robert A Whittington, MD 2123053226 raw9@cumc.columbia.edu

Locations
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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    lss4@cumc.columbia.edu   
Contact: Robert A Whittington, MD    212-305-3226    raw9@cumc.columbia.edu   
Principal Investigator: Lena S Sun, MD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Lena S Sun, MD Columbia University

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Responsible Party: Lena S. Sun, E.M. Papper Professor of Pediatric Anesthesiology, Columbia University
ClinicalTrials.gov Identifier: NCT02542683     History of Changes
Other Study ID Numbers: AAAP7626
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lena S. Sun, Columbia University:
congenital heart diseases
cognition
adaptive behavior
physical activity
neurodevelopment

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities