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RecruitingNCT06258941Updated Jun 25, 2026

Classroom Break, Cognition, and Fitness in Elementary School Children

A Phase 1/2 interventional study of MF-HIIT and HIIT-only in Healthy Volunteers, sponsored by Purdue University. Recruiting at 1 site in United States. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Purdue University · Phase 1/2, Interventional, and Prevention

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
352
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study summary

The goal of this randomized controlled trial is to learn about the effect of a 12-week school-based intervention combining mindfulness with high-intensity interval training (MF-HIIT), MF-only intervention, and HIIT-only intervention in relative to sedentary activities on executive function (EF) in 8-12 years old children. The main question it aims to answer is whether a 12-week school-based MF-HIIT intervention has larger beneficial effect on EF performance than that following a 12-week school-based MF-only and HIIT-only in relative to the sedentary activities.

Multiple cohorts of participants will be recruited to participate this one-semester study, including the pretest, intervention, and posttest phases.

During the pretest phase, participants an their parents will complete the following

  1. Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
  2. Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index
  3. Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness
  4. Computerized tasks to assess EF
  5. Parent-reported demographic and health information

Following the pretest phase, participants will receive the 12-week classroom-based intervention, with the classroom as the intervention unit.

Following the intervention and during the posttest phase, participants will complete the fitness, measures, EF measures, and dispositional mindfulness measure again.

Researcher will compare the EFn outcome measures following the MF-HIIT, MF-only, and HIIT-only interventions with the sedentary activity intervention to see if MF and HIIT has beneficial effects on children's EF.

Further, researcher will compare the EF measures following the MF-HIIT compared with MF-only and HIIT-only interventions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Executive function
  • Mindfulness
  • Interval exercise
  • Children
  • Fitness
03

In context

Lead sponsor

Purdue University is the lead sponsor of 175 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 8-12 years old
  • Intelligence Quotient ≥ 70
  • Capable of performing exercise based on pre-participation health screening
  • No formal diagnosis of neurological diseases (e.g., epilepsy)

Exclusion criteria

Exclusion Criteria:

  • Age outside of the range of 8-12 years old
  • Intelligence Quotient \< 70
  • No capable of performing exercise based on pre-participation health screening
  • Has formal diagnosis of neurological diseases (e.g., epilepsy)
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
352 participants (estimated)

Study arms

  • Experimental
    12-Week Mindful High-Intensity Interval Training (MF-HIIT)

    Behavioral: MF-HIIT

  • Active comparator
    12-Week High-Intensity Interval Training (HIIT-only)

    Behavioral: HIIT-only

  • Active comparator
    12-Week Mindfulness (MF-only)

    Behavioral: MF-only

  • Placebo comparator
    12-Week Sedentary Activities

    Behavioral: Sedentary activity

Interventions

  • BehavioralMF-HIIT

    Two 10-min MF-HIIT sessions every school day during the 12-week intervention period. One session in the morning and one session in the afternoon.

  • BehavioralHIIT-only

    Two 10-min HIIT-only sessions every school day during the 12-week intervention period. One session in the morning and one session in the afternoon.

  • BehavioralMF-only

    Two 10-min MF-only sessions every school day during the 12-week intervention period. One session in the morning and one session in the afternoon.

  • BehavioralSedentary activity

    Two 10-min sedentary sessions every school day during the 12-week intervention period. One session in the morning and one session in the afternoon.

06

What researchers measure

Primary outcomes

  1. Inhibition speed

    Inhibition speed will be assessed by the response time (ms) during a child-friendly flanker task.

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

  2. Inhibition accuracy

    Inhibition accuracy will be assessed by the response accuracy (percent) during a child-friendly flanker task.

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

  3. Updating speed

    Updating speed will be assessed by the response time (ms) during a child-friendly n-back task.

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

  4. Updating accuracy

    Updating accuracy will be assessed by the response accuracy (percent) during a child-friendly n-back task.

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

  5. Shifting speed

    Shifting speed will be assessed by the response time (ms) during a child-friendly switching task.

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

  6. Shifting accuracy

    Shifting accuracy will be assessed by the response accuracy (percent) during a child-friendly switching task.

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

Secondary outcomes

  1. Aerobic capacity

    Aerobic capacity will be assessed by the Progressive Aerobic Cardiovascular Endurance Run (PACER) test

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

  2. Upper body muscle endurance

    Upper body muscle endurance will be assessed by the push-ups test

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

  3. Core body muscle endurance

    Core body muscle endurance will be assessed by the curl-ups test

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

  4. Flexibility

    Flexibility will be assessed by the back-saver sit and reach test

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

  5. Body composition

    body composition will be assessed by the body mass index computed as weight (kg) / (height \[m\] \* height \[m\])

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

  6. Dispositional mindfulness

    Dispositional mindfulness will be assessed by the Child and Adolescent Mindfulness Measure questionnaire (CAMM). The questionnaire has 10 items and requires the respondents to rating each item using a 5-point likert scale from 0 (Never True) to 4 (Always True). Higher summed scores indicate higher levels of mindfulness

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

07

Study locations

1 of 1 sites recruiting
  • Pioneer Elementary School
    Royal Center, Indiana 46978, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06258941
Lead sponsor
Purdue University
Responsible party
Shih-Chun Kao (Assistant Professor, Purdue University) — Principal investigator
First posted
Feb 14, 2024
Start date
Feb 14, 2025
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Jun 25, 2026

Study contacts

Shih-Chun (Alvin) Kao, PhD
Contact
kao28@purdue.edu
765-496-2213

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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