Effect of Game-based HIIT Program on the Executive Function of Children With ADHD
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ClinicalTrials.gov Identifier: NCT05308758 |
Recruitment Status :
Recruiting
First Posted : April 4, 2022
Last Update Posted : April 4, 2022
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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,
Condition or disease | Intervention/treatment | Phase |
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Adhd Deficits in Attention Motor Control and Perception | Other: Game-based High-Intensity Interval Training Other: GameSAE | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | Effect of Game-based High-Intensity Interval Training Program on the Executive Function of Children With ADHD: Protocol of A Randomized Controlled Trial |
Actual Study Start Date : | January 1, 2021 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
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Experimental: GameHIIT intervention group
In the GameHIIT group, a specially designed game-based training program with HIIT in nature will be delivered to the participants for 8 weeks.
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Other: Game-based High-Intensity Interval Training
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. |
Active Comparator: GameSE intervention group
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.
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Other: GameSAE
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. |
No Intervention: Control group
No intervention.
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- Colour-Word Stroop Test (CWST) [ Time Frame: The measurements are assessed at baseline (T0). ]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.
- Corsi Block Tapping Test (CBTT) [ Time Frame: The measurements are assessed at baseline (T0). ]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.
- Wisconsin Card Sorting Test (WCST) [ Time Frame: The measurements are assessed at baseline (T0). ]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.
- Tower of London Test (TLT) [ Time Frame: The measurements are assessed at baseline (T0). ]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.
- Colour-Word Stroop Test (CWST) [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]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.
- Corsi Block Tapping Test (CBTT) [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]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.
- Wisconsin Card Sorting Test (WCST) [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]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.
- Tower of London Test (TLT) [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]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.
- Colour-Word Stroop Test (CWST) [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]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.
- Corsi Block Tapping Test (CBTT) [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]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.
- Wisconsin Card Sorting Test (WCST) [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]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.
- Tower of London Test (TLT) [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]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.
- Cerebral Hemodynamic Response [ Time Frame: The measurements are assessed at baseline (T0). ]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.
- Cerebral Hemodynamic Response [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]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.
- Cerebral Hemodynamic Response [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]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.
- Body height [ Time Frame: The measurements are assessed at baseline (T0). ]Body height will be measured in meters. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES). Weight and height will be combined to report BMI in kg/m^2.
- Body height [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]Body height will be measured in meters. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES). Weight and height will be combined to report BMI in kg/m^2.
- Body height [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]Body height will be measured in meters. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES). Weight and height will be combined to report BMI in kg/m^2.
- Body weight [ Time Frame: The measurements are assessed at baseline (T0). ]Bodyweight will be measured in kilograms. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES). Weight and height will be combined to report BMI in kg/m^2.
- Body weight [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]Bodyweight will be measured in kilograms. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES). Weight and height will be combined to report BMI in kg/m^2.
- Body weight [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]Bodyweight will be measured in kilograms. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES). Weight and height will be combined to report BMI in kg/m^2.
- Waist circumference [ Time Frame: The measurements are assessed at baseline (T0). ]Waist circumference will be measured and presented in centimetres. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES).
- Waist circumference [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]Waist circumference will be measured and presented in centimetres. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES).
- Waist circumference [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]Waist circumference will be measured and presented in centimetres. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES).
- Hip circumference [ Time Frame: The measurements are assessed at baseline (T0). ]Hip circumference will be measured and presented in centimetres. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES).
- Hip circumference [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]Hip circumference will be measured and presented in centimetres. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES).
- Hip circumference [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]Hip circumference will be measured and presented in centimetres. The measurement will follow the Anthropometry Procedures Manual of the National Health and Nutrition Examination Survey (NHANES).
- Body mass index (BMI) [ Time Frame: The measurements are assessed at baseline (T0). ]Weight and height will be combined to report BMI in kg/m^2.
- Body mass index (BMI) [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]Weight and height will be combined to report BMI in kg/m^2.
- Body mass index (BMI) [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]Weight and height will be combined to report BMI in kg/m^2.
- Social Behavior [ Time Frame: The measurements are assessed at baseline (T0). ]Conners' Teacher Rating Scale 15-Item (CTRS-15) will be used to measure the social behaviours of participants. It has been widely used to assess problematic behaviours in children with ADHD.
- Social Behavior [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]Conners' Teacher Rating Scale 15-Item (CTRS-15) will be used to measure the social behaviours of participants. It has been widely used to assess problematic behaviours in children with ADHD.
- Social Behavior [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]Conners' Teacher Rating Scale 15-Item (CTRS-15) will be used to measure the social behaviours of participants. It has been widely used to assess problematic behaviours in children with ADHD.
- Overall ADHD Symptoms [ Time Frame: The measurements are assessed at baseline (T0). ]The Overall ADHD symptoms will be assessed by the Attention-Deficit/Hyperactivity-symptoms and Normal-behaviors (SWAN) rating scale (0-3), the scale scores in '0' means 'Not true' and '3' in 'Very much true'.
- Overall ADHD Symptoms [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]The Overall ADHD symptoms will be assessed by the Attention-Deficit/Hyperactivity-symptoms and Normal-behaviors (SWAN) rating scale (0-3), the scale scores in '0' means 'Not true' and '3' in 'Very much true'.
- Overall ADHD Symptoms [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]The Overall ADHD symptoms will be assessed by the Attention-Deficit/Hyperactivity-symptoms and Normal-behaviors (SWAN) rating scale (0-3), the scale scores in '0' means 'Not true' and '3' in 'Very much true'.
- Moderate-to-Vigorous Physical Activity (MVPA) [ Time Frame: The measurements are assessed at baseline (T0). ]Children's leisure-time MVPA will be determined using an accelerometer (ActiGraph, Shalimar, USA).Participants will be required to wear an accelerometer on their right hip for seven days to collect objective data of PA levels. The time on and time off of wearing the accelerometer each day will be recorded, and the data will be used to estimate the time spent in moderate-to-vigorous PA (MVPA).
- Moderate-to-Vigorous Physical Activity (MVPA) [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]Children's leisure-time MVPA will be determined using an accelerometer (ActiGraph, Shalimar, USA).Participants will be required to wear an accelerometer on their right hip for seven days to collect objective data of PA levels. The time on and time off of wearing the accelerometer each day will be recorded, and the data will be used to estimate the time spent in moderate-to-vigorous PA (MVPA).
- Moderate-to-Vigorous Physical Activity (MVPA) [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]Children's leisure-time MVPA will be determined using an accelerometer (ActiGraph, Shalimar, USA).Participants will be required to wear an accelerometer on their right hip for seven days to collect objective data of PA levels. The time on and time off of wearing the accelerometer each day will be recorded, and the data will be used to estimate the time spent in moderate-to-vigorous PA (MVPA).
- Self-reported Physical Activity [ Time Frame: The measurements are assessed at baseline (T0). ]The modified version of the Physical Activity Questionnaire for Children (PAQ-C) is a 7-day self-report questionnaire designed to assess daily activities from moderate to the vigorous range, and the score is in a continuous range from 1 (low active) to 5 (high active).
- Self-reported Physical Activity [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]The modified version of the Physical Activity Questionnaire for Children (PAQ-C) is a 7-day self-report questionnaire designed to assess daily activities from moderate to the vigorous range, and the score is in a continuous range from 1 (low active) to 5 (high active).
- Self-reported Physical Activity [ Time Frame: The measurements are assessed after the 8-week intervention period and another 8-week follow up (T2). ]The modified version of the Physical Activity Questionnaire for Children (PAQ-C) is a 7-day self-report questionnaire designed to assess daily activities from moderate to the vigorous range, and the score is in a continuous range from 1 (low active) to 5 (high active).
- Enjoyment [ Time Frame: The measurements are assessed at baseline (T0). ]Enjoyment will be assessed by the Physical Activity Enjoyment Scale, which is a valid and reliable tool for evaluating perceived enjoyment. The PACES consisted of 18 bipolar statements on a 7-point continuum (I enjoy it-I hate it) which are summed to produce a total enjoyment score.
- Enjoyment [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]Enjoyment will be assessed by the Physical Activity Enjoyment Scale, which is a valid and reliable tool for evaluating perceived enjoyment. The PACES consisted of 18 bipolar statements on a 7-point continuum (I enjoy it-I hate it) which are summed to produce a total enjoyment score.
- Enjoyment [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]Enjoyment will be assessed by the Physical Activity Enjoyment Scale, which is a valid and reliable tool for evaluating perceived enjoyment. The PACES consisted of 18 bipolar statements on a 7-point continuum (I enjoy it-I hate it) which are summed to produce a total enjoyment score.
- Adherence [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]Adherence to the intervention program will be evaluated by attendance frequency and dropout rate.
- Physical Fitness (cardiovascular fitness) [ Time Frame: The measurements are assessed at baseline (T0). ]The cardiovascular fitness will be assessed by the 20 m shuttle run test using the ALPHA fitness test battery.
- Physical Fitness (cardiovascular fitness) [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]The cardiovascular fitness will be assessed by the 20 m shuttle run test using the ALPHA fitness test battery.
- Physical Fitness (cardiovascular fitness) [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]The cardiovascular fitness will be assessed by the 20 m shuttle run test using the ALPHA fitness test battery.
- Physical Fitness (muscular strength) [ Time Frame: The measurements are assessed at baseline (T0). ]The muscular strength will be assessed by the handgrip strength test and standing long jump test using the ALPHA fitness test battery.
- Physical Fitness (muscular strength) [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]The muscular strength will be assessed by the handgrip strength test and standing long jump test using the ALPHA fitness test battery.
- Physical Fitness (muscular strength) [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]The muscular strength will be assessed by the handgrip strength test and standing long jump test using the ALPHA fitness test battery.
- Physical Fitness (speed-agility) [ Time Frame: The measurements are assessed at baseline (T0). ]The speed-agility will be assessed by the 4 × 10 m shuttle run test using the ALPHA fitness test battery.
- Physical Fitness (speed-agility) [ Time Frame: The measurements are assessed after the 8-week intervention period (T1). ]The speed-agility will be assessed by the 4 × 10 m shuttle run test using the ALPHA fitness test battery.
- Physical Fitness (speed-agility) [ Time Frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2). ]The speed-agility will be assessed by the 4 × 10 m shuttle run test using the ALPHA fitness test battery.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Years to 13 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of ADHD
- Must be able to participate in physical activity
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05308758
Contact: Fenghua Sun, Dotcor | 852-29487854 | fhsun@eduhk.hk |
Hong Kong | |
The Education University of Hong Kong | Recruiting |
Hong Kong, Hong Kong | |
Contact: Fenghua Sun, Dotor 852-29487854 fhsun@eduhk.hk |
Study Director: | Fenghua Sun, Dotcor | The Education University of Hong Kong |
Responsible Party: | Education University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT05308758 |
Other Study ID Numbers: |
EdUHK 18603120 |
First Posted: | April 4, 2022 Key Record Dates |
Last Update Posted: | April 4, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Special education need Physical activity fNIRS |