Exercise Effects on Cognition in School-Aged Children (FITKids)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chuck Hillman, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT01334359
First received: April 8, 2011
Last updated: July 23, 2014
Last verified: July 2014

April 8, 2011
July 23, 2014
July 2008
June 2012   (final data collection date for primary outcome measure)
  • Event-related brain potentials [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: No ]
    Measures of the neuroelectric system that occur in response to, or in preparation for, a discrete event.
  • Task Performance [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: No ]
    Measures of responses speed and accuracy
  • Academic Achievement [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: No ]
    Scholastic achievement tests of reading comprehension and arithmetic.
Same as current
Complete list of historical versions of study NCT01334359 on ClinicalTrials.gov Archive Site
  • Magnetic Resonance Imaging [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: Yes ]
    Measures of brain structure.
  • functional Magnetic Resonance Imaging [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: Yes ]
    measures of brain function
  • Eye Tracking [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: No ]
    Measures of visual gaze.
  • Virtual Reality [ Time Frame: Change from baseline, 36-40 weeks) ] [ Designated as safety issue: No ]
    Measures of response speed and accuracy related to crosswalk behavior
  • Adiposity [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: Yes ]
    Measure of change in adiposity
  • Diet and Brain Function [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: No ]
    Measure of correlation between diet and brain function
  • Magnetic Resonance Imaging [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: Yes ]
    Measures of brain structure.
  • functional Magnetic Resonance Imaging [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: Yes ]
    measures of brain function
  • Eye Tracking [ Time Frame: Change from baseline, 36-40 weeks ] [ Designated as safety issue: No ]
    Measures of visual gaze.
  • Virtual Reality [ Time Frame: Change from baseline, 36-40 weeks) ] [ Designated as safety issue: No ]
    Measures or response speed and accuracy related to crosswalk behavior
Not Provided
Not Provided
 
Exercise Effects on Cognition in School-Aged Children
ERPs to Academics: Exercise Effects on Cognition in School-Aged Children

Recent trends have identified decreasing levels of physical activity, fitness, and health in preadolescent children. Examining factors, such as physical activity behavior and aerobic fitness that positively influence cognitive health of school-age children are important for improving school performance, maximizing health, and improving the overall functioning of individuals as they progress through the human lifespan. A sample of preadolescent children from the Urbana, Illinois elementary school system will be randomly assigned to a 9- month afterschool program that focuses on either aerobic exercise or wait-list control group to determine the effects of physical activity on basic and applied aspects of cognition. Changes in neuroimaging and behavioral indices of cognitive function and performance on standardized academic achievement tests of mathematics and reading will be examined as a function of participation in the intervention. Preliminary research supports that physical activity is positively associated with basic and applied aspects of cognition, with a stronger relationship for tasks requiring extensive amounts of executive control. However, previous research has mainly focused on older adults, and little research has examined the relationship between physical activity and executive control in children. These findings will provide lifestyle considerations for children to improve their cognitive health across the lifespan.

The aim of this proposal is to improve our understanding of factors related to brain health and cognition of school-aged children by examining the effects of a 9-month exercise intervention on basic and applied aspects of cognition in preadolescent children. From a basic measurement perspective, event-related brain potentials, MRI, fMRI, and behavioral indices of cognition will be studied during several tasks aimed at assessing various aspects of executive control. Preliminary research has observed faster and more efficient performance in high-fit, relative to low-fit, children and adults using neuroelectric measures that reflect attentional allocation to environmental stimuli and response monitoring processes, along with behavioral measures that reflect response speed and accuracy. These preliminary findings indicate greater top-down attentional control may be associated with increases in physical activity. From an applied measurement perspective, preliminary research has found that children with greater aerobic fitness perform better on standardized achievement tests of reading and mathematics, compared to children with lower aerobic fitness, suggesting that exercise may be related to academic performance in an applied school setting. To date, no causal evidence exists regarding the effects of physical activity on neuroelectric, behavioral, or applied school performance indices of cognition in children. Accordingly, this proposal investigates an aerobic activity training intervention on these measures of cognition using three tasks that require variable amounts of executive control, and on the Illinois Standardized Achievement Test using a randomized control design in which participants are assigned to an afterschool physical activity program or a wait-list control group. 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
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
  • Brain Health
  • Cognition
  • Scholastic Achievement
Behavioral: Physical Activity
9-month afterschool program designed to increase physical activity and aerobic fitness.
  • Experimental: Treatment Group
    Participants randomized to the 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Parental consent
  • 7.5-9.5 years
  • Capable of performing exercise
  • Absence of school-identified learning disability
  • IQ > 85
  • Tanner Scales score <= 2
  • ADHD Rating Scales score > 85%

Exclusion Criteria:

  • Non-consent of guardian
  • Above or Below age range
  • Any physical disability that prohibits exercise
  • School-identified learning disability
  • IQ < 85
  • Tanner Scales Score > 2
  • ADHD Rating Scale score < 85%
Both
8 Years to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01334359
1 R01 HD055352-01A2
Yes
Chuck Hillman, University of Illinois at Urbana-Champaign
University of Illinois at Urbana-Champaign
Not Provided
Principal Investigator: Charles H Hillman, PHD University of Illinois at Urbana-Champaign
University of Illinois at Urbana-Champaign
July 2014

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