Clinical trial NCT06270589: Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children
Official title: Supporting High-intensity Interval Training With Mindfulness for Enhancing Childhood Executive Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Keywords: Interval Exercise
Mindfulness
Executive function
Brain function
Children
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: University of Oregon
First posted: 2024-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Inhibition speed
timeFrame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
measure: Inhibition accuracy
timeFrame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
measure: Shifting speed
timeFrame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
measure: Shifting accuracy
timeFrame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
measure: N2-ERP
timeFrame: At the baseline before and about 10-min after the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
measure: P3-ERP
timeFrame: 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:
measure: State Mindfulness Scale for Physical Activity (SMSPA)
timeFrame: Immediately after completing the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
measure: Rating of perceived exertion
timeFrame: 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.
measure: Heart Rate
timeFrame: 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 outcomes:
measure: Dispositional mindfulness
timeFrame: At baseline on Day 1 before receiving any intervention
Locations:
city: West Lafayette
country: United States
facility: Lambert, 800 West Stadium Avenue
state: Indiana
Study officials:
References: