The Effects of 12-Week High-intensity Interval Training With Mindfulness-based Recovery on Executive Function, Fitness, and Mindfulness in Children

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

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 10-12 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Behavioral: MF-HIIT; Behavioral: HIIT-only; Behavioral: MF-only; Behavioral: Sedentary activity

• Study Type: Interventional
• Enrollment (Estimated): 352
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shih-Chun (Alvin) Kao, PhD; Phone Number: 765-496-2213; Email: kao28@purdue.edu

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue University
      • Contact: Shih-Chun (Alvin) Kao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12-Week Mindful High-Intensity Interval Training (MF-HIIT)	Behavioral: MF-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.
Active Comparator: 12-Week High-Intensity Interval Training (HIIT-only)	Behavioral: HIIT-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.
Active Comparator: 12-Week Mindfulness (MF-only)	Behavioral: MF-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.
Placebo Comparator: 12-Week Sedentary Activities	Behavioral: Sedentary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhibition speed	Inhibition speed will be assessed by the response time (ms) during a child-friendly flanker task.	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Updating speed	Updating speed will be assessed by the response time (ms) during a child-friendly n-back task.	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Shifting speed	Shifting speed will be assessed by the response time (ms) during a child-friendly switching task.	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Inhibition accuracy	Inhibition accuracy will be assessed by the response accuracy (percent) during a child-friendly flanker task.	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Updating accuracy	Updating accuracy will be assessed by the response accuracy (percent) during a child-friendly n-back task.	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Shifting accuracy	Shifting accuracy will be assessed by the response accuracy (percent) during a child-friendly switching task.	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic capacity	Aerobic capacity will be assessed by the Progressive Aerobic Cardiovascular Endurance Run (PACER) test	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Upper body muscle endurance	Upper body muscle endurance will be assessed by the push-ups test	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Core body muscle endurance	Core body muscle endurance will be assessed by the curl-ups test	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Flexibility	Flexibility will be assessed by the back-saver sit and reach test	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Body composition	body composition will be assessed by the body mass index computed as weight (kg) / (height [m] * height [m])	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
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	At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

Collaborators and Investigators

• Sponsor: Purdue University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Children; Mindfulness; Fitness; Executive function; Interval exercise
• Other Study ID Numbers: IRB-2023-1683

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No