Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03592238
Other study ID # 1R01HD094054-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 10, 2019
Est. completion date October 2024

Study information

Verified date November 2023
Source Northeastern University
Contact Charles Hillman
Phone 617-373-8342
Email c.hillman@northeastern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date October 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Northeastern University Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neuroelectric outcome P3 - ERP baseline
Primary Neuroelectric outcome P3 - ERP ~1 hr after arriving at lab, after completing the experimental condition
Primary inhibitory control accuracy baseline
Primary inhibitory control reaction time baseline
Primary working memory accuracy baseline
Primary working memory reaction time baseline
Primary inhibitory control accuracy ~1 hr after arriving at lab, after completing the experimental condition
Primary inhibitory control reaction time ~1 hr after arriving at lab, after completing the experimental condition
Primary working memory accuracy ~1 hr after arriving at lab, after completing the experimental condition
Primary working memory reaction time ~1 hr after arriving at lab, after completing the experimental condition
Primary Academic Achievement outcome WRAT3 (Wide Range, Inc., Wilmington, DE) Reading Accuracy ~1.5 hrs after arriving at lab, after completing the experimental condition
Primary Academic Achievement outcome WRAT3 (Wide Range, Inc., Wilmington, DE) Spelling Accuracy ~1.5 hrs after arriving at lab, after completing the experimental condition
Primary Academic Achievement outcome WRAT3 (Wide Range, Inc., Wilmington, DE) Math Accuracy ~1.5 hrs after arriving at lab, after completing the experimental condition
See also
  Status Clinical Trial Phase
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT05108181 - Muscle Typology and Strength Training Adaptations N/A
Recruiting NCT05052918 - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes N/A
Completed NCT04508270 - Significance of Early Mobilization After VATS-L
Recruiting NCT04994340 - Physical Activity Observatory of Castilla-La Mancha
Completed NCT04815980 - Impact of Pilates on Running Mechanics N/A
Completed NCT05189795 - The Construction of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
Completed NCT03683758 - Effects of the FIFA11+ Warm-up Program on Speed, Agility, and Vertical Jump Performance in Adult Female Amateur Soccer Players N/A
Completed NCT05538520 - Effects of Pilates Stretching on Flexibility, Strength, Power and Muscular Endurance N/A
Completed NCT06315036 - Effects of Developmental Gymnastics on Preschoolers' Motor Skills N/A
Completed NCT03171064 - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment Phase 2
Recruiting NCT05496751 - Response Variability to Exercise N/A
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04207359 - Effects of Creatine Supplementation in Breast Cancer Survivors N/A
Completed NCT03832205 - Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Completed NCT03297567 - Physical Therapy Guidelines For Hospitalized Elderly N/A
Completed NCT03477188 - The Effects of Somatosensory and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke. N/A
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A