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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01619826
Other study ID # HD069381
Secondary ID R01HD069381-01A1
Status Completed
Phase N/A
First received June 12, 2012
Last updated July 11, 2017
Start date April 2012
Est. completion date May 2017

Study information

Verified date July 2017
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 9 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical Activity
9-month afterschool program designed to increase physical activity and aerobic fitness.
Physical Activity
Participants in this group partake in their regular afterschool activities, without intervention from the study staff.

Locations

Country Name City State
United States Beckman Institute - Biomedical Imaging Center Urbana Illinois
United States Campus Recreation Center East Urbana Illinois
United States Department of Kinesiology and Community Health Urbana Illinois
United States University of Illinois at Urbana-Champaign Urbana Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary NeuroCognitive Assessment Normed computerized test battery for cognitive testing Change from baseline, 36 - 40 weeks
Primary Structural Magnetic Resonance Imaging Measures of brain structure Change from baseline, 36 - 40 weeks
Primary Functional Magnetic Resonance Imaging Measures of brain function Change from baseline, 36 - 40 weeks
Primary Academic Achievement Scholastic achievement tests of reading comprehension and arithmetic Change from baseline, 36 - 40 weeks
Primary Eye Tracking Measures of visual gaze Change from baseline, 36 - 40 weeks
Primary Task Performance Measures of responses speed and accuracy Change from baseline, 36 - 40 weeks
Secondary 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
Secondary DXA Body Mass Assessment Measures of bone density, total body composition, and fat content Change from baseline, 36 - 40 weeks
Secondary Diet and Brain Function Measure of correlation between diet and brain function Change from baseline, 36-40 weeks
Secondary Adiposity Measure of change in adiposity Change from baseline, 36 - 40 weeks
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