Clinical trial NCT01619826: Enhancing Children's Cognitive and Brain Health Through Physical Activity Training (FITKids2)
Official title: Enhancing Children's Cognitive and Brain Health Through Physical Activity Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Ability, General
Achievement
Keywords: physical activity
fitness
brain health
cognition
scholastic achievement
preadolescent children
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-06-14
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: NeuroCognitive Assessment
timeFrame: Change from baseline, 36 - 40 weeks
measure: Structural Magnetic Resonance Imaging
timeFrame: Change from baseline, 36 - 40 weeks
measure: Functional Magnetic Resonance Imaging
timeFrame: Change from baseline, 36 - 40 weeks
measure: Academic Achievement
timeFrame: Change from baseline, 36 - 40 weeks
measure: Eye Tracking
timeFrame: Change from baseline, 36 - 40 weeks
measure: Task Performance
timeFrame: Change from baseline, 36 - 40 weeks
Secondary outcomes:
measure: Event-related Brain Potentials
timeFrame: Change from baseline, 36 - 40 weeks
measure: DXA Body Mass Assessment
timeFrame: Change from baseline, 36 - 40 weeks
measure: Diet and Brain Function
timeFrame: Change from baseline, 36-40 weeks
measure: Adiposity
timeFrame: Change from baseline, 36 - 40 weeks
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Beckman Institute - Biomedical Imaging Center
state: Illinois
city: Urbana
country: United States
facility: Campus Recreation Center East
state: Illinois
city: Urbana
country: United States
facility: Department of Kinesiology and Community Health
state: Illinois
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Arthur F Kramer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Urbana-Champaign
name: Charles Hillman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu R, Hannon BA, Robinson KN, Raine LB, Hammond BR, Renzi-Hammond LM, Cohen NJ, Kramer AF, Hillman CH, Teran-Garcia M, Khan NA. Single Nucleotide Polymorphisms in CD36 Are Associated with Macular Pigment among Children. J Nutr. 2021 Sep 4;151(9):2533-2540. doi: 10.1093/jn/nxab153.
citation: Chojnacki MR, Holscher HD, Balbinot AR, Raine LB, Biggan JR, Walk AM, Kramer AF, Cohen NJ, Hillman CH, Khan NA. Relations between mode of birth delivery and timing of developmental milestones and adiposity in preadolescence: A retrospective study. Early Hum Dev. 2019 Feb;129:52-59. doi: 10.1016/j.earlhumdev.2018.12.021. Epub 2019 Jan 12.
citation: Chojnacki MR, Raine LB, Drollette ES, Scudder MR, Kramer AF, Hillman CH, Khan NA. The Negative Influence of Adiposity Extends to Intraindividual Variability in Cognitive Control Among Preadolescent Children. Obesity (Silver Spring). 2018 Feb;26(2):405-411. doi: 10.1002/oby.22053. Epub 2017 Dec 27.
citation: Raine LB, Khan NA, Drollette ES, Pontifex MB, Kramer AF, Hillman CH. Obesity, Visceral Adipose Tissue, and Cognitive Function in Childhood. J Pediatr. 2017 Aug;187:134-140.e3. doi: 10.1016/j.jpeds.2017.05.023. Epub 2017 Jun 13.
citation: Barnett SM, Khan NA, Walk AM, Raine LB, Moulton C, Cohen NJ, Kramer AF, Hammond BR Jr, Renzi-Hammond L, Hillman CH. Macular pigment optical density is positively associated with academic performance among preadolescent children. Nutr Neurosci. 2018 Nov;21(9):632-640. doi: 10.1080/1028415X.2017.1329976. Epub 2017 May 23.
citation: Hassevoort KM, Khazoum SE, Walker JA, Barnett SM, Raine LB, Hammond BR, Renzi-Hammond LM, Kramer AF, Khan NA, Hillman CH, Cohen NJ. Macular Carotenoids, Aerobic Fitness, and Central Adiposity Are Associated Differentially with Hippocampal-Dependent Relational Memory in Preadolescent Children. J Pediatr. 2017 Apr;183:108-114.e1. doi: 10.1016/j.jpeds.2017.01.016. Epub 2017 Feb 8.
citation: Baym CL, Khan NA, Monti JM, Raine LB, Drollette ES, Moore RD, Scudder MR, Kramer AF, Hillman CH, Cohen NJ. Dietary lipids are differentially associated with hippocampal-dependent relational memory in prepubescent children. Am J Clin Nutr. 2014 May;99(5):1026-32. doi: 10.3945/ajcn.113.079624. Epub 2014 Feb 12.