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

Cognitive Ability, General Clinical Trial

— FITKids2  

Official title:

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

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
• 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

Related Conditions & MeSH terms

• Achievement
• Cognitive Ability, General

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

External Links

•   FITKids Website