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Sympathetic Nervous System Mediation of Acute Exercise Effects on Childhood Brain and Cognition

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ClinicalTrials.gov Identifier: NCT03592238
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Chuck Hillman, Northeastern University

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.


Condition or disease Intervention/treatment Phase
Exercise Cognition Other: Aerobic Exercise Intervention Other: Trier Social Stress Test for Children Other: Seated Rest Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sympathetic Nervous System Mediation of Acute Exercise Effects on Childhood Brain and Cognition
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exercise Intervention
Participants will exercise on a motor-driven treadmill at a constant speed during the 23-min period.
Other: Aerobic Exercise Intervention
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.

Active Comparator: Trier Social Stress Test for Children
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
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.

Placebo Comparator: Seated Rest
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
Children will be asked to sit quietly or read a book of their choosing.




Primary Outcome Measures :
  1. Neuroelectric outcome [ Time Frame: baseline ]
    P3 - ERP

  2. Neuroelectric outcome [ Time Frame: ~1 hr after arriving at lab, after completing the experimental condition ]
    P3 - ERP

  3. inhibitory control [ Time Frame: baseline ]
    accuracy

  4. inhibitory control [ Time Frame: baseline ]
    reaction time

  5. working memory [ Time Frame: baseline ]
    accuracy

  6. working memory [ Time Frame: baseline ]
    reaction time

  7. inhibitory control [ Time Frame: ~1 hr after arriving at lab, after completing the experimental condition ]
    accuracy

  8. inhibitory control [ Time Frame: ~1 hr after arriving at lab, after completing the experimental condition ]
    reaction time

  9. working memory [ Time Frame: ~1 hr after arriving at lab, after completing the experimental condition ]
    accuracy

  10. working memory [ Time Frame: ~1 hr after arriving at lab, after completing the experimental condition ]
    reaction time

  11. Academic Achievement outcome [ Time Frame: ~1.5 hrs after arriving at lab, after completing the experimental condition ]
    WRAT3 (Wide Range, Inc., Wilmington, DE) Reading Accuracy

  12. Academic Achievement outcome [ Time Frame: ~1.5 hrs after arriving at lab, after completing the experimental condition ]
    WRAT3 (Wide Range, Inc., Wilmington, DE) Spelling Accuracy

  13. Academic Achievement outcome [ Time Frame: ~1.5 hrs after arriving at lab, after completing the experimental condition ]
    WRAT3 (Wide Range, Inc., Wilmington, DE) Math Accuracy



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592238


Contacts
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Contact: Charles Hillman 617-373-8342 c.hillman@northeastern.edu
Contact: Lauren Raine l.raine@northeastern.edu

Locations
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United States, Massachusetts
Northeastern University Recruiting
Boston, Massachusetts, United States, 02115
Contact: Charles Hillman       c.hillman@northeastern.edu   
Sponsors and Collaborators
Northeastern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chuck Hillman, Professor, Northeastern University
ClinicalTrials.gov Identifier: NCT03592238    
Other Study ID Numbers: 1R01HD094054-01 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No