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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01334359
Other study ID # 1R01HD055352-01A2
Secondary ID
Status Completed
Phase Phase 3
First received April 8, 2011
Last updated July 23, 2014
Start date July 2008
Est. completion date June 2012

Study information

Verified date July 2014
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 252
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 9 Years
Eligibility 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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity
9-month afterschool program designed to increase physical activity and aerobic fitness.

Locations

Country Name City State
United States University of Illinois Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event-related brain potentials Measures of the neuroelectric system that occur in response to, or in preparation for, a discrete event. Change from baseline, 36-40 weeks No
Primary Task Performance Measures of responses speed and accuracy Change from baseline, 36-40 weeks No
Primary Academic Achievement Scholastic achievement tests of reading comprehension and arithmetic. Change from baseline, 36-40 weeks No
Secondary Magnetic Resonance Imaging Measures of brain structure. Change from baseline, 36-40 weeks Yes
Secondary functional Magnetic Resonance Imaging measures of brain function Change from baseline, 36-40 weeks Yes
Secondary Eye Tracking Measures of visual gaze. Change from baseline, 36-40 weeks No
Secondary Virtual Reality Measures of response speed and accuracy related to crosswalk behavior Change from baseline, 36-40 weeks) No
Secondary Adiposity Measure of change in adiposity Change from baseline, 36-40 weeks Yes
Secondary Diet and Brain Function Measure of correlation between diet and brain function Change from baseline, 36-40 weeks No
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