NCT01619826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

5.1 years

First QC Date

June 12, 2012

Last Update Submit

July 11, 2017

Conditions

Cognitive Ability, GeneralAchievement

Keywords

physical activityfitnessbrain healthcognitionscholastic achievementpreadolescent children

Outcome Measures

Primary Outcomes (6)

  • NeuroCognitive Assessment

    Normed computerized test battery for cognitive testing

    Change from baseline, 36 - 40 weeks

  • Structural Magnetic Resonance Imaging

    Measures of brain structure

    Change from baseline, 36 - 40 weeks

  • Functional Magnetic Resonance Imaging

    Measures of brain function

    Change from baseline, 36 - 40 weeks

  • Academic Achievement

    Scholastic achievement tests of reading comprehension and arithmetic

    Change from baseline, 36 - 40 weeks

  • Eye Tracking

    Measures of visual gaze

    Change from baseline, 36 - 40 weeks

  • Task Performance

    Measures of responses speed and accuracy

    Change from baseline, 36 - 40 weeks

Secondary Outcomes (4)

  • Event-related Brain Potentials

    Change from baseline, 36 - 40 weeks

  • DXA Body Mass Assessment

    Change from baseline, 36 - 40 weeks

  • Diet and Brain Function

    Change from baseline, 36-40 weeks

  • Adiposity

    Change from baseline, 36 - 40 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants randomized to the physical activity-based afterschool intervention

Behavioral: Physical Activity

Wait List Group

PLACEBO COMPARATOR

Participants in this group partake in their regular afterschool activities, without intervention from the study staff.

Behavioral: Physical Activity

Interventions

Physical ActivityBEHAVIORAL

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

Treatment Group

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parental/guardian consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beckman Institute - Biomedical Imaging Center

Urbana, Illinois, 61801, United States

Location

Campus Recreation Center East

Urbana, Illinois, 61801, United States

Location

Department of Kinesiology and Community Health

Urbana, Illinois, 61801, United States

Location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (7)

  • 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.

    PMID: 34049394DERIVED

  • 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.

    PMID: 30641478DERIVED

  • 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.

    PMID: 29282881DERIVED

  • 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.

    PMID: 28622956DERIVED

  • 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.

    PMID: 28535707DERIVED

  • 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.

    PMID: 28189300DERIVED

  • 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.

    PMID: 24522447DERIVED

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Arthur F Kramer, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

  • Charles Hillman, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations

US(4)