- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06270589
Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children
Supporting High-intensity Interval Training With Mindfulness for Enhancing Childhood Executive Function
The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are:
Question 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest
Question 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest
Participants will visit the laboratory on 5 separate days (> 2-day washout between days) in which they have not previously participated in structured physical activities.
Participants will complete the testing and/or receive treatments below:
Day 1:
- Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
- Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption)
Days 2-5
- Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting)
- Participants' heart rate and self-reported affect and rating of physical exertion will be measured
- Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility
- Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performance
Researcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF.
Further, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shih-Chun Kao, PhD
- Phone Number: 765-496-2213
- Email: kao28@purdue.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 10-12 years old
- Intelligence Quotient ≥ 85
- Capable of performing exercise based on pre-participation health screening
- No formal diagnosis of cognitive disorders (e.g., attention deficit hyperactivity disorder) and neurological diseases (e.g., epilepsy)
Exclusion Criteria:
- Age outside of the range of 10-12 years old
- Intelligence Quotient < 85
- No capable of performing exercise based on pre-participation health screening
- Has formal diagnosis of cognitive disorders (e.g., attention deficit hyperactivity disorder) and neurological diseases (e.g., epilepsy)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A Single Bout Of Mindful High-Intensity Interval Training (Mindful HIIT)
|
A single bout of 20-min MF-HIIT protocol delivered through a motor-driven treadmill.
The protocol will start with a 1.5-min warm-up, then a 16.5-min main exercise (6 x 90s exercise intervals separated by 5 x 90s mindful intervals), and finally a 2-min cool-down.
|
Active Comparator: A Single Bout Of High-Intensity Interval Training (HIIT)
|
A single bout of 20-min HIIT protocol delivered through a motor-driven treadmill.
The protocol will start with a 1.5-min warm-up, then a 16.5-min main exercise (6 x 90s exercise intervals separated by 5 x 90s rest intervals), and finally a 2-min cool-down.
|
Active Comparator: A Single Bout Of Mindfulness
|
A single bout of 20-min intervention mindfulness intervention that includes 5 x 90s mindful intervals separated by sitting rest
|
Other: A Single Bout Of Sitting Rest
|
Participants will sit in a comfortable chair, placed on the treadmill, while watching a HIIT video without mindfulness instructions for 20 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inhibition speed
Time Frame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
Inhibition speed will be assessed by the response time (ms) during a child-friendly flanker task.
|
At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
Inhibition accuracy
Time Frame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
Inhibition accuracy will be assessed by the response accuracy (%) during a child-friendly flanker task.
|
At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
Shifting speed
Time Frame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
The shifting speed will be assessed by the response time (ms) during a child-friendly switching task.
|
At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
Shifting accuracy
Time Frame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
The shifting accuracy will be assessed by the response accuracy (%) during a child-friendly switching task.
|
At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
N2-ERP
Time Frame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
The N2 component of event-related brain potentials is a neuroelectric index of conflict processing.
Increased amplitude of N2 reflects increased neural activation to detect and resolve conflicts.
|
At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
P3-ERP
Time Frame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
The P3 component of event-related brain potentials is a neuroelectric index of attention.
Increased amplitude of P3 reflects greater allocation of attentional resources and the decreased latency of P3 reflects the faster information processing speed.
|
At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State Mindfulness Scale for Physical Activity (SMSPA)
Time Frame: Immediately after completing the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
A developmentally-appropriate and validated 12-item, 5-point Likert scaled (0-4), instrument to measure self-reported mindfulness state in children aged above 10 years old.
This measure will serve as a manipulation check on mindfulness induction during each of the 4 intervention conditions.
|
Immediately after completing the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
Rating of perceived exertion
Time Frame: Measure at 0 second, 90 seconds, 180 seconds, 270 seconds, 360 seconds, 450 seconds, 540 seconds, 630 seconds, 720 seconds, 810 seconds, 900 seconds, 990 seconds, 1080 seconds and 1200 seconds of the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
The 10-point Children's OMNI rating of perceived exertion will be used as a manipulation check on the intensity of prescribed exercise for the school-based programs as well as the laboratory-based acute interventions.
|
Measure at 0 second, 90 seconds, 180 seconds, 270 seconds, 360 seconds, 450 seconds, 540 seconds, 630 seconds, 720 seconds, 810 seconds, 900 seconds, 990 seconds, 1080 seconds and 1200 seconds of the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
Heart Rate
Time Frame: Heart rate will be measured at every minute (minutes 0, 1, 2, 3, 4, ...., 18, 19, 20) during the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
Heart rate will serve as a manipulation check on the intensity of prescribed exercise.
|
Heart rate will be measured at every minute (minutes 0, 1, 2, 3, 4, ...., 18, 19, 20) during the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dispositional mindfulness
Time Frame: At baseline on Day 1 before receiving any intervention
|
Child and Adolescent Mindfulness Measure (CAMM) provides a validated and reliable measure of dispositional mindfulness in children using 10 items and 5-point Likert scale (0-4), with a higher total score indicating the participant is more mindful.
This measure will be used as the secondary outcome measure to to check the intervention manipulation.
|
At baseline on Day 1 before receiving any intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- IRB-2023-1684
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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