NCT03592238

Brief Summary

Today's children have become increasingly inactive and unfit, with \>50% of children not meeting the recommended 60 min of moderate-to-vigorous physical activity. Previous research has suggested that acute aerobic exercise of moderate intensity was associated with improved cognition manifested by improved performance and increased P3 amplitude, a neuroelectric indicator that reflects the amount of attentional allocation, in tasks requiring cognitive control. While minimal evidence exists to support potential mechanisms underlying the transient effects of exercise on brain and cognition, research suggests that phasic changes in the locus coeruleus-norepinephrine (LC-NE) (as measured by salivary alpha amylase (sAA)) system are a potential mechanism for explaining the acute effect of exercise on brain and cognition. Accordingly, the aim of this study is to examine the mechanisms linking acute aerobic exercise to improved cognitive control as well as the underlying neuroelectrical activities in children, using electroencephalography (EEG) and event-related potentials (ERPs). We hope to gain a better understanding of the role of acute exercise and cognitive and brain health. The results from this study will help identify mechanisms linking acute exercise to enhanced cognitive performance in children. Our hypothesis is that exercise-induced phasic increases in sympathetic nervous system activity will mediate the effect of a single bout of exercise on brain function, cognition, and standardized achievement test performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
297

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

February 10, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

5.4 years

First QC Date

June 12, 2018

Last Update Submit

June 4, 2025

Conditions

Outcome Measures

Primary Outcomes (13)

  • Neuroelectric outcome

    P3 - ERP

    baseline

  • Neuroelectric outcome

    P3 - ERP

    ~1 hr after arriving at lab, after completing the experimental condition

  • inhibitory control

    accuracy

    baseline

  • inhibitory control

    reaction time

    baseline

  • working memory

    accuracy

    baseline

  • working memory

    reaction time

    baseline

  • inhibitory control

    accuracy

    ~1 hr after arriving at lab, after completing the experimental condition

  • inhibitory control

    reaction time

    ~1 hr after arriving at lab, after completing the experimental condition

  • working memory

    accuracy

    ~1 hr after arriving at lab, after completing the experimental condition

  • working memory

    reaction time

    ~1 hr after arriving at lab, after completing the experimental condition

  • Academic Achievement outcome

    WRAT3 (Wide Range, Inc., Wilmington, DE) Reading Accuracy

    ~1.5 hrs after arriving at lab, after completing the experimental condition

  • Academic Achievement outcome

    WRAT3 (Wide Range, Inc., Wilmington, DE) Spelling Accuracy

    ~1.5 hrs after arriving at lab, after completing the experimental condition

  • Academic Achievement outcome

    WRAT3 (Wide Range, Inc., Wilmington, DE) Math Accuracy

    ~1.5 hrs after arriving at lab, after completing the experimental condition

Study Arms (3)

Aerobic Exercise Intervention

EXPERIMENTAL

Participants will exercise on a motor-driven treadmill at a constant speed during the 23-min period.

Other: Aerobic Exercise Intervention

Trier Social Stress Test for Children

ACTIVE COMPARATOR

The Trier Social Stress Test for Children consists of a speech task in which children must finish a story and a mental arithmetic task, completed in front of a camera and two neutral observers.

Other: Trier Social Stress Test for Children

Seated Rest

PLACEBO COMPARATOR

Participants will sit in a comfortable chair, placed in the same room as the motor-driven treadmill, for a period of 25-min.

Other: Seated Rest

Interventions

The protocol will include a 25-min bout of exercise at an intensity of 75% HRmax, such that participants will engage in a 1-min warm up and a 1-min cool down, with the majority of time (i.e., 23-min) spent exercising at 75% of HRmax.

Aerobic Exercise Intervention

Participants will be asked to imagine that they are in a new class with 20 other students, and that their teacher has asked them to stand in front of the class and introduce themselves. The mental arithmetic task will entail asking children to serially subtract the number 5 from a larger number as quickly as possible.

Trier Social Stress Test for Children

Children will be asked to sit quietly or read a book of their choosing.

Seated Rest

Eligibility Criteria

Age9 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parental/guardian consent (non-consent of guardian).
  • Participants must have had no prior diagnosis of cognitive or physical disability, including attention deficit hyperactivity disorder (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
  • Participants must be free of any type of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for attention deficit hyperactivity disorder (use of any anti-psychotic, anti-depressant, anti-anxiety, and attention deficit hyperactivity disorder medications).
  • Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
  • Participants must have not yet reached, or be in the earliest stages, of puberty, as measured by a modified test of the Tanner Staging System (onset of puberty as determined by Tanner).
  • English speaking.

You may not qualify if:

  • Participants with an intelligence quotient below 85 will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Lloyd KM, Gabard-Durnam L, Beaudry K, De Lisio M, Raine LB, Bernard-Willis Y, Watrous JNH, Whitfield-Gabrieli S, Kramer AF, Hillman CH. Cross-sectional analysis reveals COVID-19 pandemic community lockdown was linked to dysregulated cortisol and salivary alpha amylase in children. Front Public Health. 2023 Dec 15;11:1210122. doi: 10.3389/fpubh.2023.1210122. eCollection 2023.

  • Raine LB, Erickson KI, Grove G, Watrous JNH, McDonald K, Kang C, Jakicic JM, Forman DE, Kramer AF, Burns JM, Vidoni ED, McAuley E, Hillman CH. Cardiorespiratory fitness levels and body mass index of pre-adolescent children and older adults during the COVID-19 pandemic. Front Public Health. 2023 Jan 17;10:1052389. doi: 10.3389/fpubh.2022.1052389. eCollection 2022.

  • Raine LB, McDonald K, Shigeta TT, Hsieh SS, Hunt J, Chiarlitti NA, Lim M, Gebhardt K, Collins N, De Lisio M, Mullen SP, Kramer AF, Hillman C. Sympathetic Nervous System and Exercise Affects Cognition in Youth (SNEACY): study protocol for a randomized crossover trial. Trials. 2021 Feb 18;22(1):154. doi: 10.1186/s13063-021-05096-w.

MeSH Terms

Conditions

Motor Activity

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2018

First Posted

July 19, 2018

Study Start

February 10, 2019

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

June 22, 2025

Record last verified: 2025-06

Locations