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Brain HealthPhase 3FITKidsNCT01334359

Exercise Effects on Cognition in School-Aged Children

A Phase 3 study testing Physical Activity in people with Brain Health and Cognition, run by University of Illinois at Urbana-Champaign at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Recent trends have identified decreasing levels of physical activity, fitness, and health in preadolescent children. Examining factors, such as physical activity behavior and aerobic fitness that positively influence cognitive health of school-age children are important for improving school performance, maximizing… Read more about this study

Who is it for?
Ages 8 to 9 yearsHealthy volunteers can take part
Conditions the study is for
Brain Health, Cognition, Scholastic Achievement
What is being tested?
Physical Activity
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
1 siteUnited States
Study dates
Jul 2008to Jun 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Parental consent
  • 7.5-9.5 years
  • Capable of performing exercise
  • Absence of school-identified learning disability
  • IQ > 85
  • Tanner Scales score <= 2
  • ADHD Rating Scales score > 85%

Who cannot join

  • Non-consent of guardian
  • Above or Below age range
  • Any physical disability that prohibits exercise
  • School-identified learning disability
  • IQ < 85
  • Tanner Scales Score > 2
  • ADHD Rating Scale score < 85%

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois

    Urbana, Illinois, 61801

Other trials in United States

About this study

Official title: ERPs to Academics: Exercise Effects on Cognition in School-Aged Children

Recent trends have identified decreasing levels of physical activity, fitness, and health in preadolescent children. Examining factors, such as physical activity behavior and aerobic fitness that positively influence cognitive health of school-age children are important for improving school performance, maximizing health, and improving the overall functioning of individuals as they progress through the human lifespan. A sample of preadolescent children from the Urbana, Illinois elementary school system will be randomly assigned to a 9- month afterschool program that focuses on either aerobic exercise or wait-list control group to determine the effects of physical activity on basic and applied aspects of cognition. Changes in neuroimaging and behavioral indices of cognitive function and performance on standardized academic achievement tests of mathematics and reading will be examined as a function of participation in the intervention. Preliminary research supports that physical activity is positively associated with basic and applied aspects of cognition, with a stronger relationship for tasks requiring extensive amounts of executive control. However, previous research has mainly focused on older adults, and little research has examined the relationship between physical activity and executive control in children. These findings will provide lifestyle considerations for children to improve their cognitive health across the lifespan.

Read the detailed description

The aim of this proposal is to improve our understanding of factors related to brain health and cognition of school-aged children by examining the effects of a 9-month exercise intervention on basic and applied aspects of cognition in preadolescent children. From a basic measurement perspective, event-related brain potentials, MRI, fMRI, and behavioral indices of cognition will be studied during several tasks aimed at assessing various aspects of executive control. Preliminary research has observed faster and more efficient performance in high-fit, relative to low-fit, children and adults using neuroelectric measures that reflect attentional allocation to environmental stimuli and response monitoring processes, along with behavioral measures that reflect response speed and accuracy. These preliminary findings indicate greater top-down attentional control may be associated with increases in physical activity. From an applied measurement perspective, preliminary research has found that children with greater aerobic fitness perform better on standardized achievement tests of reading and mathematics, compared to children with lower aerobic fitness, suggesting that exercise may be related to academic performance in an applied school setting. To date, no causal evidence exists regarding the effects of physical activity on neuroelectric, behavioral, or applied school performance indices of cognition in children. Accordingly, this proposal investigates an aerobic activity training intervention on these measures of cognition using three tasks that require variable amounts of executive control, and on the Illinois Standardized Achievement Test using a randomized control design in which participants are assigned to an afterschool physical activity program or a wait-list control group. 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.

Being tested
Physical Activity
Keywords
physical activity, fitness, brain health, cognition, scholastic achievement, preadolescent children
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical ActivityBehavioural

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

Study groups in NCT01334359
Study groupRoleWhat they receive
Treatment GroupExperimentalParticipants randomized to the afterschool intervention
Receives: Behavioral: Physical Activity
Wait List GroupPlacebo comparatorParticipants in this group partake in their regular afterschool activities, without intervention from the study staff.
Receives: Behavioral: Physical Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-related brain potentials

    Measures of the neuroelectric system that occur in response to, or in preparation for, a discrete event.

    Measured: Change from baseline, 36-40 weeks

  2. Task Performance

    Measures of responses speed and accuracy

    Measured: Change from baseline, 36-40 weeks

  3. Academic Achievement

    Scholastic achievement tests of reading comprehension and arithmetic.

    Measured: Change from baseline, 36-40 weeks

Secondary outcomes (6)

  1. Magnetic Resonance Imaging

    Measures of brain structure.

    Measured: Change from baseline, 36-40 weeks

  2. functional Magnetic Resonance Imaging

    measures of brain function

    Measured: Change from baseline, 36-40 weeks

  3. Eye Tracking

    Measures of visual gaze.

    Measured: Change from baseline, 36-40 weeks

  4. Virtual Reality

    Measures of response speed and accuracy related to crosswalk behavior

    Measured: Change from baseline, 36-40 weeks)

  5. Adiposity

    Measure of change in adiposity

    Measured: Change from baseline, 36-40 weeks

  6. Diet and Brain Function

    Measure of correlation between diet and brain function

    Measured: Change from baseline, 36-40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2011 (estimated)
  2. Study startJul 2008
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01334359
Sponsor's protocol ID
1R01HD055352-01A2
Acronym
FITKids
Status last verified
Jul 2014
First submitted
8 Apr 2011
Last updated
25 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Logan NE, Westfall DR, Raine LB, Anteraper SA, Chaddock-Heyman L, Whitfield-Gabrieli S, Kramer AF, Hillman CH. The Differential Effects of Adiposity and Fitness on Functional Connectivity in Preadolescent Children. Med Sci Sports Exerc. 2022 Oct 1;54(10):1702-1713. doi: 10.1249/MSS.0000000000002964. Epub 2022 Jun 24.

    PubMed 35763600

  • 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.

    PubMed 30641478

  • 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.

    PubMed 28622956

  • Hillman CH, Pontifex MB, Castelli DM, Khan NA, Raine LB, Scudder MR, Drollette ES, Moore RD, Wu CT, Kamijo K. Effects of the FITKids randomized controlled trial on executive control and brain function. Pediatrics. 2014 Oct;134(4):e1063-71. doi: 10.1542/peds.2013-3219.

    PubMed 25266425

  • Khan NA, Raine LB, Drollette ES, Scudder MR, Pontifex MB, Castelli DM, Donovan SM, Evans EM, Hillman CH. Impact of the FITKids physical activity intervention on adiposity in prepubertal children. Pediatrics. 2014 Apr;133(4):e875-83. doi: 10.1542/peds.2013-2246. Epub 2014 Mar 31.

    PubMed 24685956

  • 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.

    PubMed 24522447

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Physical Activity in people with Brain Health and Cognition, run by University of Illinois at Urbana-Champaign at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-related brain potentials (time frame: Change from baseline, 36-40 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01334359, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.

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