Enhancing Children's Cognitive and Brain Health Through Physical Activity Training (FITKids2) (FITKids2)

Enhancing Children's Cognitive and Brain Health Through Physical Activity Training

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Urbana, Illinois, United States, 61801
        • University of Illinois at Urbana-Champaign
      • Urbana, Illinois, United States, 61801
        • Beckman Institute - Biomedical Imaging Center
      • Urbana, Illinois, United States, 61801
        • Campus Recreation Center East
      • Urbana, Illinois, United States, 61801
        • Department of Kinesiology and Community Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Participants randomized to the physical activity-based afterschool intervention
9-month afterschool program designed to increase physical activity and aerobic fitness.
Participants in this group partake in their regular afterschool activities, without intervention from the study staff.
Placebo Comparator: Wait List Group
Participants in this group partake in their regular afterschool activities, without intervention from the study staff.
9-month afterschool program designed to increase physical activity and aerobic fitness.
Participants in this group partake in their regular afterschool activities, without intervention from the study staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NeuroCognitive Assessment
Time Frame: Change from baseline, 36 - 40 weeks
Normed computerized test battery for cognitive testing
Change from baseline, 36 - 40 weeks
Structural Magnetic Resonance Imaging
Time Frame: Change from baseline, 36 - 40 weeks
Measures of brain structure
Change from baseline, 36 - 40 weeks
Functional Magnetic Resonance Imaging
Time Frame: Change from baseline, 36 - 40 weeks
Measures of brain function
Change from baseline, 36 - 40 weeks
Academic Achievement
Time Frame: Change from baseline, 36 - 40 weeks
Scholastic achievement tests of reading comprehension and arithmetic
Change from baseline, 36 - 40 weeks
Eye Tracking
Time Frame: Change from baseline, 36 - 40 weeks
Measures of visual gaze
Change from baseline, 36 - 40 weeks
Task Performance
Time Frame: Change from baseline, 36 - 40 weeks
Measures of responses speed and accuracy
Change from baseline, 36 - 40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline, 36 - 40 weeks
DXA Body Mass Assessment
Time Frame: Change from baseline, 36 - 40 weeks
Measures of bone density, total body composition, and fat content
Change from baseline, 36 - 40 weeks
Diet and Brain Function
Time Frame: Change from baseline, 36-40 weeks
Measure of correlation between diet and brain function
Change from baseline, 36-40 weeks
Adiposity
Time Frame: Change from baseline, 36 - 40 weeks
Measure of change in adiposity
Change from baseline, 36 - 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arthur F Kramer, PhD, University of Illinois at Urbana-Champaign
  • Principal Investigator: Charles Hillman, PhD, University of Illinois at Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimate)

June 14, 2012

Study Record Updates

Last Update Posted (Actual)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HD069381
  • R01HD069381-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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