Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function 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: NCT06270589
• Other study ID #: IRB-2023-1684
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2026

Study information

• Verified date: February 2024
• Source: Purdue University
• Contact: Shih-Chun 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2026
• Est. primary completion date: May 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
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.
• MF-only
A single bout of 20-min intervention mindfulness intervention that includes 5 x 90s mindful intervals separated by sitting rest
• HIIT-only
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.
• Sitting rest
Participants will sit in a comfortable chair, placed on the treadmill, while watching a HIIT video without mindfulness instructions for 20 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	University of Oregon

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dispositional mindfulness	Child and Adolescent Mindfulness Measure (CAMM) provides a validated and reliable measure of dispositional mindfulness in children using 10 items and 5-point Likert scale (0-4), with a higher total score indicating the participant is more mindful. This measure will be used as the secondary outcome measure to to check the intervention manipulation.	At baseline on Day 1 before receiving any intervention
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	State Mindfulness Scale for Physical Activity (SMSPA)	A developmentally-appropriate and validated 12-item, 5-point Likert scaled (0-4), instrument to measure self-reported mindfulness state in children aged above 10 years old. This measure will serve as a manipulation check on mindfulness induction during each of the 4 intervention conditions.	Immediately after completing the 20-min intervention on Day 2, Day 3, Day 4, and Day 5.
Secondary	Rating of perceived exertion	The 10-point Children's OMNI rating of perceived exertion will be used as a manipulation check on the intensity of prescribed exercise for the school-based programs as well as the laboratory-based acute interventions.	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.
Secondary	Heart Rate	Heart rate will serve as a manipulation check on the intensity of prescribed exercise.	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.