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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258941
• Other study ID #: IRB-2023-1683
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: February 2024
• Source: Purdue University
• Contact: Shih-Chun (Alvin) Kao, PhD
• Phone: 765-496-2213
• Email: kao28[@]purdue.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 352
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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