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Completed

NCT Number: NCT01334359

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.

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Key information

Age range

8 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Illinois

Urbana, Illinois, 61801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Physical activity

Behavioral

9-month afterschool program designed to increase physical activity and aerobic fitness.

Primary outcomes

  1. 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.

  2. Task Performance

    Time frame: Change from baseline, 36-40 weeks

    Measures of responses speed and accuracy

  3. Academic Achievement

    Time frame: Change from baseline, 36-40 weeks

    Scholastic achievement tests of reading comprehension and arithmetic.

Secondary outcomes

  1. Magnetic Resonance Imaging

    Time frame: Change from baseline, 36-40 weeks

    Measures of brain structure.

  2. functional Magnetic Resonance Imaging

    Time frame: Change from baseline, 36-40 weeks

    measures of brain function

  3. Eye Tracking

    Time frame: Change from baseline, 36-40 weeks

    Measures of visual gaze.

  4. Virtual Reality

    Time frame: Change from baseline, 36-40 weeks)

    Measures of response speed and accuracy related to crosswalk behavior

  5. Adiposity

    Time frame: Change from baseline, 36-40 weeks

    Measure of change in adiposity

  6. Diet and Brain Function

    Time frame: Change from baseline, 36-40 weeks

    Measure of correlation between diet and brain function

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study title

ERPs to Academics: Exercise Effects on Cognition in School-Aged Children

Acronym: FITKids

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2011
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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