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Recruiting NCT06270589

Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children

No phase Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MF-HIIT, MF-only, HIIT-only, Sitting rest.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 10 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Supporting High-intensity Interval Training With Mindfulness for Enhancing Childhood Executive Function

Overview

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.

Interventions

  • Behavioral MF-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.
  • Behavioral MF-only
    A single bout of 20-min intervention mindfulness intervention that includes 5 x 90s mindful intervals separated by sitting rest
  • Behavioral HIIT-only
    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.
  • Behavioral Sitting rest
    Participants will sit in a comfortable chair, placed on the treadmill, while watching a HIIT video without mindfulness instructions for 20 minutes.

Primary outcome measures

  • 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 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (3)
  • 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.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Lambert, 800 West Stadium Avenue — West Lafayette

Identifiers

NCT: NCT06270589 · IRB-2023-1684 · 1R21HD110656-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗