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Clinical Trials/NCT06258941
NCT06258941
Recruiting
Phase 1

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

Purdue University1 site in 1 country352 target enrollmentFebruary 14, 2025

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Healthy Volunteers
Sponsor
Purdue University
Enrollment
352
Locations
1
Primary Endpoint
Updating speed
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 14, 2025
End Date
May 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shih-Chun Kao

Assistant Professor

Purdue University

Eligibility Criteria

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

  • 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)

Outcomes

Primary Outcomes

Updating speed

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

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

Shifting speed

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

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

Inhibition accuracy

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

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

Inhibition speed

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

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

Updating accuracy

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

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

Shifting accuracy

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

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

Secondary Outcomes

  • Body composition(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)
  • Core body muscle endurance(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)
  • Aerobic capacity(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)
  • Dispositional mindfulness(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)
  • Flexibility(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)
  • Upper body muscle endurance(At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends)

Study Sites (1)

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