We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01334359
First Posted: April 13, 2011
Last Update Posted: July 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chuck Hillman, University of Illinois at Urbana-Champaign
  Purpose
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.

Condition Intervention Phase
Brain Health Cognition Scholastic Achievement Behavioral: Physical Activity Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: ERPs to Academics: Exercise Effects on Cognition in School-Aged Children

Resource links provided by NLM:


Further study details as provided by Chuck Hillman, University of Illinois at Urbana-Champaign:

Primary Outcome Measures:
  • 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.

  • Task Performance [ Time Frame: Change from baseline, 36-40 weeks ]
    Measures of responses speed and accuracy

  • Academic Achievement [ Time Frame: Change from baseline, 36-40 weeks ]
    Scholastic achievement tests of reading comprehension and arithmetic.


Secondary Outcome Measures:
  • 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

  • Eye Tracking [ Time Frame: Change from baseline, 36-40 weeks ]
    Measures of visual gaze.

  • Virtual Reality [ Time Frame: Change from baseline, 36-40 weeks) ]
    Measures of response speed and accuracy related to crosswalk behavior

  • Adiposity [ Time Frame: Change from baseline, 36-40 weeks ]
    Measure of change in adiposity

  • Diet and Brain Function [ Time Frame: Change from baseline, 36-40 weeks ]
    Measure of correlation between diet and brain function


Enrollment: 252
Study Start Date: July 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group
Participants randomized to the afterschool intervention
Behavioral: Physical Activity
9-month afterschool program designed to increase physical activity and aerobic fitness.
Placebo Comparator: Wait List Group
Participants in this group partake in their regular afterschool activities, without intervention from the study staff.
Behavioral: Physical Activity
9-month afterschool program designed to increase physical activity and aerobic fitness.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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%
  Contacts and Locations
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): NCT01334359


Locations
United States, Illinois
University of Illinois
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
Principal Investigator: Charles H Hillman, PHD University of Illinois at Urbana-Champaign