NCT06270589

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
0mo left

Started Jun 2024

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Jun 2024May 2026

First Submitted

Initial submission to the registry

January 29, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

January 29, 2024

Last Update Submit

April 17, 2025

Conditions

Keywords

Interval ExerciseMindfulnessExecutive functionBrain functionChildren

Outcome Measures

Primary Outcomes (6)

  • Inhibition speed

    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

    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

    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

    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

    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

    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 Outcomes (3)

  • State Mindfulness Scale for Physical Activity (SMSPA)

    Immediately after completing the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.

  • Rating of perceived exertion

    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 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 (1)

  • Dispositional mindfulness

    At baseline on Day 1 before receiving any intervention

Study Arms (4)

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

Interventions

MF-HIITBEHAVIORAL

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.

A Single Bout Of Mindful High-Intensity Interval Training (Mindful HIIT)
MF-onlyBEHAVIORAL

A single bout of 20-min intervention mindfulness intervention that includes 5 x 90s mindful intervals separated by sitting rest

A Single Bout Of Mindfulness
HIIT-onlyBEHAVIORAL

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.

A Single Bout Of High-Intensity Interval Training (HIIT)
Sitting restBEHAVIORAL

Participants will sit in a comfortable chair, placed on the treadmill, while watching a HIIT video without mindfulness instructions for 20 minutes.

A Single Bout Of Sitting Rest

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lambert, 800 West Stadium Avenue

West Lafayette, Indiana, 47907, United States

RECRUITING

Central Study Contacts

Shih-Chun Kao, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 21, 2024

Study Start

June 15, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations