ExerciseNCT03592238
Sympathetic Nervous System Mediation of Acute Exercise Effects on Childhood Brain and Cognition
A study testing Aerobic Exercise Intervention, Trier Social Stress Test for Children and Seated Rest in people with Exercise and Cognition, run by Northeastern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- What is being tested?
- Aerobic Exercise Intervention, Trier Social Stress Test for Children and Seated Rest
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2019to 30 Jun 2024
- Phase
- Interventional
- 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 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Participants with an intelligence quotient below 85 will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeastern University
Boston, Massachusetts, 02115
About this study
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.
- Being tested
- Aerobic Exercise Intervention, Trier Social Stress Test for Children, Seated Rest
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise InterventionOther
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.
Trier Social Stress Test for ChildrenOther
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.
Seated RestOther
Children will be asked to sit quietly or read a book of their choosing.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Intervention | Experimental | Participants will exercise on a motor-driven treadmill at a constant speed during the 23-min period. Receives: 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. Receives: 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. Receives: Other: Seated Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroelectric outcome
P3 - ERP
Measured: baseline
Neuroelectric outcome
P3 - ERP
Measured: ~1 hr after arriving at lab, after completing the experimental condition
inhibitory control
accuracy
Measured: baseline
inhibitory control
reaction time
Measured: baseline
working memory
accuracy
Measured: baseline
working memory
reaction time
Measured: baseline
inhibitory control
accuracy
Measured: ~1 hr after arriving at lab, after completing the experimental condition
inhibitory control
reaction time
Measured: ~1 hr after arriving at lab, after completing the experimental condition
working memory
accuracy
Measured: ~1 hr after arriving at lab, after completing the experimental condition
working memory
reaction time
Measured: ~1 hr after arriving at lab, after completing the experimental condition
Academic Achievement outcome
WRAT3 (Wide Range, Inc., Wilmington, DE) Reading Accuracy
Measured: ~1.5 hrs after arriving at lab, after completing the experimental condition
Academic Achievement outcome
WRAT3 (Wide Range, Inc., Wilmington, DE) Spelling Accuracy
Measured: ~1.5 hrs after arriving at lab, after completing the experimental condition
Academic Achievement outcome
WRAT3 (Wide Range, Inc., Wilmington, DE) Math Accuracy
Measured: ~1.5 hrs after arriving at lab, after completing the experimental condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start10 Feb 2019
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Chuck Hillman, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592238
- Sponsor's protocol ID
- 1R01HD094054-01
- Other IDs
- R01HD094054
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2018
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38169630Raine 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.
PubMed 36733279Raine 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.
PubMed 33602325
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Nervous System Mediation of Acute Exercise Effects on Childhood Brain and Cognition
- ClinicalTrials.gov ID
- NCT03592238
- Acronym / sponsor ID
- 1R01HD094054-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Intervention | Experimental | Other: Aerobic Exercise InterventionParticipants will exercise on a motor-driven treadmill at a constant speed during the 23-min period. |
| Trier Social Stress Test for Children | Active comparator | Other: Trier Social Stress Test for ChildrenThe 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. |
| Seated Rest | Placebo comparator | Other: Seated RestParticipants will sit in a comfortable chair, placed in the same room as the motor-driven treadmill, for a period of 25-min. |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- Participants with an intelligence quotient below 85 will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise InterventionThe 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. | Other | Aerobic Exercise Intervention |
| Trier Social Stress Test for ChildrenParticipants 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. | Other | Trier Social Stress Test for Children |
| Seated RestChildren will be asked to sit quietly or read a book of their choosing. | Other | Seated Rest |
Primary outcome
Neuroelectric outcome
Time frame: baseline
P3 - ERP
Neuroelectric outcome
Time frame: ~1 hr after arriving at lab, after completing the experimental condition
P3 - ERP
inhibitory control
Time frame: baseline
accuracy
inhibitory control
Time frame: baseline
reaction time
working memory
Time frame: baseline
accuracy
working memory
Time frame: baseline
reaction time
inhibitory control
Time frame: ~1 hr after arriving at lab, after completing the experimental condition
accuracy
inhibitory control
Time frame: ~1 hr after arriving at lab, after completing the experimental condition
reaction time
working memory
Time frame: ~1 hr after arriving at lab, after completing the experimental condition
accuracy
working memory
Time frame: ~1 hr after arriving at lab, after completing the experimental condition
reaction time
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Derived from this study: PubMed 38169630Lloyd 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.
- Derived from this study: PubMed 36733279Raine 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.
- Derived from this study: PubMed 33602325Raine 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Intervention, Trier Social Stress Test for Children and Seated Rest in people with Exercise and Cognition, run by Northeastern University 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 6 inclusion and 1 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 22 Jun 2025. 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.
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?
Neuroelectric outcome (time frame: baseline). The study lists 13 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 NCT03592238, which also lists 3 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 22 Jun 2025.