Healthy VolunteersNCT06270589
Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children
A study testing MF-HIIT, MF-only and HIIT-only in people with Healthy Volunteers, run by Purdue University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MF-HIIT, MF-only and HIIT-only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lambert, 800 West Stadium Avenue
West Lafayette, Indiana, 47907
Shih-Chun Kao, PhD, 765-496-2213, kao28@purdue.edu
About this study
Official title: 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
Read more
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.
- Conditions
- Healthy Volunteers
- Being tested
- MF-HIIT, MF-only, HIIT-only, Sitting rest
- Keywords
- Interval Exercise, Mindfulness, Executive function, Brain function, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF-HIITBehavioural
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.
MF-onlyBehavioural
A single bout of 20-min intervention mindfulness intervention that includes 5 x 90s mindful intervals separated by sitting rest
HIIT-onlyBehavioural
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.
Sitting restBehavioural
Participants will sit in a comfortable chair, placed on the treadmill, while watching a HIIT video without mindfulness instructions for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| A Single Bout Of Mindful High-Intensity Interval Training (Mindful HIIT) | Experimental | Not described Receives: Behavioral: MF-HIIT |
| A Single Bout Of High-Intensity Interval Training (HIIT) | Active comparator | Not described Receives: Behavioral: HIIT-only |
| A Single Bout Of Mindfulness | Active comparator | Not described Receives: Behavioral: MF-only |
| A Single Bout Of Sitting Rest | Other | Not described Receives: Behavioral: Sitting rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition speed
Inhibition speed will be assessed by the response time (ms) during a child-friendly flanker task.
Measured: 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
Inhibition accuracy will be assessed by the response accuracy (%) during a child-friendly flanker task.
Measured: 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
The shifting speed will be assessed by the response time (ms) during a child-friendly switching task.
Measured: 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
The shifting accuracy will be assessed by the response accuracy (%) during a child-friendly switching task.
Measured: 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
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.
Measured: 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
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.
Measured: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
Secondary outcomes (3)
State Mindfulness Scale for Physical Activity (SMSPA)
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.
Measured: Immediately after completing the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
Rating of perceived exertion
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.
Measured: 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
Heart rate will serve as a manipulation check on the intensity of prescribed exercise.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start15 Jun 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oregon
- Responsible party
- Principal investigator, Shih-Chun Kao, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270589
- Sponsor's protocol ID
- IRB-2023-1684
- Other IDs
- 1R21HD110656-01A1
- Status last verified
- Jun 2026
- First submitted
- 29 Jan 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting High-intensity Interval Training With Mindfulness for Enhancing Childhood Executive Function
- ClinicalTrials.gov ID
- NCT06270589
- Acronym / sponsor ID
- IRB-2023-1684
- Conditions
- Healthy Volunteers
- Keywords
- Interval Exercise, Mindfulness, Executive function, Brain function, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- University of Oregon
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Feb 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A Single Bout Of Mindful High-Intensity Interval Training (Mindful HIIT) | Experimental | Behavioral: MF-HIIT |
| A Single Bout Of High-Intensity Interval Training (HIIT) | Active comparator | Behavioral: HIIT-only |
| A Single Bout Of Mindfulness | Active comparator | Behavioral: MF-only |
| A Single Bout Of Sitting Rest | Other | Behavioral: Sitting rest |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| MF-HIITA 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. | Behavioural | A Single Bout Of Mindful High-Intensity Interval Training (Mindful HIIT) |
| MF-onlyA single bout of 20-min intervention mindfulness intervention that includes 5 x 90s mindful intervals separated by sitting rest | Behavioural | A Single Bout Of Mindfulness |
| HIIT-onlyA 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. | Behavioural | A Single Bout Of High-Intensity Interval Training (HIIT) |
| Sitting restParticipants will sit in a comfortable chair, placed on the treadmill, while watching a HIIT video without mindfulness instructions for 20 minutes. | Behavioural | A Single Bout Of Sitting Rest |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MF-HIIT, MF-only and HIIT-only in people with Healthy Volunteers, run by Purdue 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shih-Chun Kao, PhD (765-496-2213, kao28@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.