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Completed

NCT Number: NCT01619826

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

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.

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Key information

Age range

8 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beckman Institute - Biomedical Imaging Center, Urbana, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Physical activity

Behavioral

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

Primary outcomes

  1. NeuroCognitive Assessment

    Time frame: Change from baseline, 36 - 40 weeks

    Normed computerized test battery for cognitive testing

  2. Structural Magnetic Resonance Imaging

    Time frame: Change from baseline, 36 - 40 weeks

    Measures of brain structure

  3. Functional Magnetic Resonance Imaging

    Time frame: Change from baseline, 36 - 40 weeks

    Measures of brain function

  4. Academic Achievement

    Time frame: Change from baseline, 36 - 40 weeks

    Scholastic achievement tests of reading comprehension and arithmetic

  5. Eye Tracking

    Time frame: Change from baseline, 36 - 40 weeks

    Measures of visual gaze

  6. Task Performance

    Time frame: Change from baseline, 36 - 40 weeks

    Measures of responses speed and accuracy

Secondary 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. DXA Body Mass Assessment

    Time frame: Change from baseline, 36 - 40 weeks

    Measures of bone density, total body composition, and fat content

  3. Diet and Brain Function

    Time frame: Change from baseline, 36-40 weeks

    Measure of correlation between diet and brain function

  4. Adiposity

    Time frame: Change from baseline, 36 - 40 weeks

    Measure of change in adiposity

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: FITKids2

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2012
Registry last updated
Jul 14, 2017

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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