Effect of Game-based HIIT Program on the Executive Function of Children With ADHD

NCT05308758 | Completed

• 1 other identifier: EdUHK 18603120
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Attention-deficit/hyperactivity disorder (ADHD) is a common developmental disorder in childhood, with a 5%-6% worldwide prevalence. Children with ADHD often demonstrate impaired executive function, which is closely related to the development of the commonly observed behavioral problems such as inattention, impaired inhibition, and hyperactivity. The purpose of this study is to examine whether a game-based high-intensity interval training (HIIT) program can improve the executive function of children with ADHD, compared with a traditional structured aerobic exercise program and a non-treatment control group. Methods/design: A total of 42 children with ADHD will be recruited to participate in this three-arm school-based randomized controlled trial. An 8-week specially designed game-based HIIT (GameHIIT) program and a traditional game-based structured aerobic exercise (GameSAE) program will be delivered to those children randomly assigned to these two intervention groups, while the children in the control group will maintain their regular physical activity over the same period. A number of outcome measures including executive function, cerebral hemodynamic response, physical activity, physical fitness, and enjoyment and adherence to the intervention will be assessed for both groups at baseline (T0), immediately after the intervention period (T1), and after the follow-up period (T2). Discussion: HIIT has recently emerged as a feasible and efficacious strategy for increasing physical health outcomes and cognitive function, including executive function, in healthy young people. However, research has yet to investigate whether the executive function of children with ADHD can be effectively enhanced through HIIT. If, as hypothesized, GameHIIT program improves outcomes for children with ADHD, the present research will inform the development of targeted exercise programs that can be more broadly used with this particular population. Keywords: Special education need, Physical activity, fNIRS,

Conditions

Adhd Deficits in Attention Motor Control and Perception

Keywords

Special education need; Physical activity; fNIRS

Outcome Measures

Primary Outcomes (15)

• Colour-Word Stroop Test (CWST)

  The executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed at baseline (T0).

• Corsi Block Tapping Test (CBTT)

  Executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed at baseline (T0).

• Wisconsin Card Sorting Test (WCST)

  The executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of the important components of executive function.

  The measurements are assessed at baseline (T0).

• Tower of London Test (TLT)

  Executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed at baseline (T0).

• Colour-Word Stroop Test (CWST)

  Executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed after the 8-week intervention period (T1).

• Corsi Block Tapping Test (CBTT)

  Executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed after the 8-week intervention period (T1).

• Wisconsin Card Sorting Test (WCST)

  Executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed after the 8-week intervention period (T1).

• Tower of London Test (TLT)

  Executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed after the 8-week intervention period (T1).

• Colour-Word Stroop Test (CWST)

  Executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).

• Corsi Block Tapping Test (CBTT)

  Executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).

• Wisconsin Card Sorting Test (WCST)

  Executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).

• Tower of London Test (TLT)

  Executive function will be assessed using a battery of tests on a laptop computer that will take approximately five minutes to complete. The battery of tests include the Colour-Word Stroop Test (CWST), Corsi Block Tapping Test (CBTT), Wisconsin Card Sorting Test (WCST), and Tower of London Test (TLT) which are classic tasks that measure inhibition response, one of important components of executive function.

  The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).

• Cerebral Hemodynamic Response

  Accompanied by the executive function test, the cortical hemodynamic response in the prefrontal cortex will also be recorded using a multi-channel fNIRS (Octamon fNIRS system, Artinis, Netherland) applying two wavelengths of near-infrared light (785 and 830 nm). The device consists of eight light sources and two detectors secured onto a head cap. The device will be placed over the left and right prefrontal cortex according to the guidelines in the handbook provided by the manufacturer.

  The measurements are assessed at baseline (T0).

• Cerebral Hemodynamic Response

  Accompanied by the executive function test, the cortical hemodynamic response in the prefrontal cortex will also be recorded using a multi-channel fNIRS (Octamon fNIRS system, Artinis, Netherland) applying two wavelengths of near-infrared light (785 and 830 nm). The device consists of eight light sources and two detectors secured onto a head cap. The device will be placed over the left and right prefrontal cortex according to the guidelines in the handbook provided by the manufacturer.

  The measurements are assessed after the 8-week intervention period (T1).

• Cerebral Hemodynamic Response

  Accompanied by the executive function test, the cortical hemodynamic response in the prefrontal cortex will also be recorded using a multi-channel fNIRS (Octamon fNIRS system, Artinis, Netherland) applying two wavelengths of near-infrared light (785 and 830 nm). The device consists of eight light sources and two detectors secured onto a head cap. The device will be placed over the left and right prefrontal cortex according to the guidelines in the handbook provided by the manufacturer.

  The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).

Secondary Outcomes (40)

• Body height

  The measurements are assessed at baseline (T0).

• Body height

  The measurements are assessed after the 8-week intervention period (T1).

• Body height

  The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).

• Body weight

  The measurements are assessed at baseline (T0).

• Body weight

  The measurements are assessed after the 8-week intervention period (T1).

Study Arms (3)

GameHIIT intervention group

EXPERIMENTAL

In the GameHIIT group, a specially designed game-based training program with HIIT in nature will be delivered to the participants for 8 weeks.

Other: Game-based High-Intensity Interval Training

GameSE intervention group

ACTIVE COMPARATOR

In the GameSAE group, participants will attend a tailor-made game-based exercise training program. Similar to GameHIIT, the intervention will comprise 8 weeks of structured aerobic exercise sessions, lasting one hour on average in each session and up to twice per week.

Other: GameSAE

Control group

NO INTERVENTION

No intervention.

Interventions

Game-based High-Intensity Interval Training OTHER

There will be two training sessions each week. In each training session, there will be four sets of training programs separated by 3 minutes of passive recovery in accordance with a previous study.Each set of activities will last for around 5 minutes; therefore, the total duration of each training session will be approximately 30 minutes. A small group size (4-6 children per group) will be adopted to facilitate individual supervision and adaption of the exercise program.

GameHIIT intervention group

GameSAE OTHER

Similar to GameHIIT, the intervention will comprise 8 weeks of structured aerobic exercise sessions, lasting one hour on average in each session and up to twice per week. Six to eight stations of multidimensional exercises will be set up for each session. Adopting the train-the-trainer (TTT) model, training will be provided by front-line healthcare providers or trained helpers. Children will be instructed to finish the exercises in all stations one after another in a predetermined order.

GameSE intervention group

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of ADHD
• Must be able to participate in physical activity

You may not qualify if:

• Neurodevelopmental or psychiatric disorder (e.g., autism spectrum disorder, intellectual disability.
• Acute/chronic diseases that may affect engagement in physical activity
• A tendency to experience convulsions

Sponsors & Collaborators

• Education University of Hong Kong: lead

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Fenghua Sun, Dotcor

  The Education University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be blinded to treatment allocation because of the intervention nature. To avoid contamination between treatment groups, intervention deliverers will be provided with a list of students in the intervention program. Only those on the list can participate in the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: April 4, 2022
• Study Start: January 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 8, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)