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Enhancing Children's Cognitive and Brain Health Through Physical Activity Training (FITKids2) (FITKids2)

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT01619826
First received: June 12, 2012
Last updated: July 11, 2017
Last verified: July 2017
June 12, 2012
July 11, 2017
April 2012
May 2017   (Final data collection date for primary outcome measure)
  • NeuroCognitive Assessment [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Normed computerized test battery for cognitive testing
  • Structural Magnetic Resonance Imaging [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Measures of brain structure
  • Functional Magnetic Resonance Imaging [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Measures of brain function
  • Academic Achievement [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Scholastic achievement tests of reading comprehension and arithmetic
  • Eye Tracking [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Measures of visual gaze
  • Task Performance [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Measures of responses speed and accuracy
Same as current
Complete list of historical versions of study NCT01619826 on ClinicalTrials.gov Archive Site
  • Event-related Brain Potentials [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Measures of the neuroelectric system that occur in response to, or in preparation for, a discrete event
  • DXA Body Mass Assessment [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Measures of bone density, total body composition, and fat content
  • Diet and Brain Function [ Time Frame: Change from baseline, 36-40 weeks ]
    Measure of correlation between diet and brain function
  • Adiposity [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Measure of change in adiposity
  • Event-related Brain Potentials [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Measures of the neuroelectric system that occur in response to, or in preparation for, a discrete event
  • DXA Body Mass Assessment [ Time Frame: Change from baseline, 36 - 40 weeks ]
    Measures of bone density, total body composition, and fat content
Not Provided
Not Provided
 
Enhancing Children's Cognitive and Brain Health Through Physical Activity Training (FITKids2)
Enhancing Children's Cognitive and Brain Health Through Physical Activity Training
The objective of this study is to use a randomized controlled design to determine whether cardiorespiratory fitness training improves neurocognitive function and academic performance during preadolescent development.
The long term objective of this project is to develop an understanding of lifestyle factors that influence the cognitive and brain health of children while also reducing the sedentary nature of today's youth. Previous research has found that physical activity interventions can enhance both a variety of aspects of cognition and brain structure and function of children, older adults, and individuals with neurodegenerative disorders such as Parkinson's disease and multiple sclerosis. More specifically, in previous research with children the researchers have found that higher fit children possess larger hippocampi which in turn are related to better relational memory than their lower fit counterparts. The researchers have also observed that higher fit children exhibit more efficient executive control as indicated by performance measures and event-related brain potentials. While intriguing, these cross-sectional data do not enable us to establish causality between physical activity and cognition. In the current study the researchers substantially extend this previous research by examining the influence of a 9 month randomized controlled afterschool physical activity program on cognition and brain health. Cognition will be assessed with a battery of tasks and standardized achievement tests both before and after the 9 month intervention in the activity group and a wait list control (who will receive the intervention the following year). Children will also participate in magnetic resonance imaging (MRI) sessions both before and after the intervention (and at comparable times for the wait list control). In these sessions the researchers will measure both structural aspects of the brain including regional volumes of gray matter and the integrity of the white matter tracts (through diffusion tensor imaging) and functional aspects of brain function using fMRI activity recorded as the children perform a series of executive control and memory tasks. The researchers anticipate, based on our cross-sectional studies with children and our previous longitudinal studies with older adults, that the children in the physical activity program will show both larger regional brain volumes, particularly in brain regions that subserve executive control and relational memory, and more efficient brain function, as indexed by task-related and resting state fMRI. Furthermore, the researchers anticipate that these changes will be accompanied by improvements in memory and executive control processes. Given recent trends identifying decreased levels of physical activity and health status in preadolescents, the understanding of the potential benefits of physical activity on cognition is of great interest. It is imperative that factors positively influencing cognitive function of children be examined to maximize health and effective functioning of individuals as they progress through the lifespan.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Primary Purpose: Basic Science
  • Cognitive Ability, General
  • Achievement
  • Behavioral: Physical Activity
    9-month afterschool program designed to increase physical activity and aerobic fitness.
  • Behavioral: Physical Activity
    Participants in this group partake in their regular afterschool activities, without intervention from the study staff.
  • Experimental: Treatment Group
    Participants randomized to the physical activity-based afterschool intervention
    Intervention: Behavioral: Physical Activity
  • Placebo Comparator: Wait List Group
    Participants in this group partake in their regular afterschool activities, without intervention from the study staff.
    Intervention: Behavioral: Physical Activity
Baym CL, Khan NA, Monti JM, Raine LB, Drollette ES, Moore RD, Scudder MR, Kramer AF, Hillman CH, Cohen NJ. Dietary lipids are differentially associated with hippocampal-dependent relational memory in prepubescent children. Am J Clin Nutr. 2014 May;99(5):1026-32. doi: 10.3945/ajcn.113.079624. Epub 2014 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
May 2017
May 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Parental/guardian consent
  • 8 - 9 years old
  • Capable of performing exercise
  • Absence of school-identified learning disability
  • IQ >= 85
  • Tanner Scales score <= 2
  • ADHD Rating Scales score >= 85%
  • Right hand dominant
  • Absence of metal implants
  • Not claustrophobic

Exclusion Criteria:

  • Non-consent of guardian
  • Above or below 8 - 9 years old
  • Any physical disability that prohibits exercise
  • School-identified learning disability
  • IQ < 85
  • Tanner Scales score > 2
  • ADHD Rating Scale score < 85%
  • Left hand dominant
  • Presence of metal implants
  • Claustrophobic
Sexes Eligible for Study: All
8 Years to 9 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01619826
HD069381
R01HD069381-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Illinois at Urbana-Champaign
University of Illinois at Urbana-Champaign
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Arthur F Kramer, PhD University of Illinois at Urbana-Champaign
Principal Investigator: Charles Hillman, PhD University of Illinois at Urbana-Champaign
University of Illinois at Urbana-Champaign
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP