- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03592238
Sympathetic Nervous System Mediation of Acute Exercise Effects on Childhood Brain and Cognition
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Charles Hillman
- Phone Number: 617-373-8342
- Email: c.hillman@northeastern.edu
Study Contact Backup
- Name: Lauren Raine
- Email: l.raine@northeastern.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Northeastern University
-
Contact:
- Charles Hillman
- Email: c.hillman@northeastern.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic Exercise Intervention
Participants will exercise on a motor-driven treadmill at a constant speed during the 23-min period.
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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.
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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.
|
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.
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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.
|
Children will be asked to sit quietly or read a book of their choosing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuroelectric outcome
Time Frame: baseline
|
P3 - ERP
|
baseline
|
Neuroelectric outcome
Time Frame: ~1 hr after arriving at lab, after completing the experimental condition
|
P3 - ERP
|
~1 hr after arriving at lab, after completing the experimental condition
|
inhibitory control
Time Frame: baseline
|
accuracy
|
baseline
|
inhibitory control
Time Frame: baseline
|
reaction time
|
baseline
|
working memory
Time Frame: baseline
|
accuracy
|
baseline
|
working memory
Time Frame: baseline
|
reaction time
|
baseline
|
inhibitory control
Time Frame: ~1 hr after arriving at lab, after completing the experimental condition
|
accuracy
|
~1 hr after arriving at lab, after completing the experimental condition
|
inhibitory control
Time Frame: ~1 hr after arriving at lab, after completing the experimental condition
|
reaction time
|
~1 hr after arriving at lab, after completing the experimental condition
|
working memory
Time Frame: ~1 hr after arriving at lab, after completing the experimental condition
|
accuracy
|
~1 hr after arriving at lab, after completing the experimental condition
|
working memory
Time Frame: ~1 hr after arriving at lab, after completing the experimental condition
|
reaction time
|
~1 hr after arriving at lab, after completing the experimental condition
|
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
|
~1.5 hrs after arriving at lab, after completing the experimental condition
|
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
|
~1.5 hrs after arriving at lab, after completing the experimental condition
|
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
|
~1.5 hrs after arriving at lab, after completing the experimental condition
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R01HD094054-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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