Adhd Deficits in Attention Motor Control and PerceptionNCT05308758
Effect of Game-based HIIT Program on the Executive Function of Children With ADHD
A study testing Game-based High-Intensity Interval Training and GameSAE in people with Adhd Deficits in Attention Motor Control and Perception, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Adhd Deficits in Attention Motor Control and Perception
- What is being tested?
- Game-based High-Intensity Interval Training and GameSAE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of ADHD
- Must be able to participate in physical activity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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,
Read the detailed description
There is strong evidence that regular physical activity (PA) is associated with a range of physical health benefits for school-age youth, including improvements in body composition, physical capacity, and overall health-related indicators (e.g., blood pressure, insulin resistance, lipid profile). Emerging evidence also suggests that PA and physical fitness have a positive effect on mental health, cognitive function, and academic performance. Executive functions are generally defined as "high-level cognitive processes" that manage other basic cognitive functions. They consist of functions such as planning, self-regulation, initiation and inhibition, and cognitive flexibility. These functions are believed to be important prerequisites for successful learning in preadolescent children, predict better health and wealth, and have been associated with a reduced likelihood of being convicted of a criminal offense. Several recent meta-analyses have suggested that PA may positively affect cognition and executive function in children. Despite the known benefits of an active lifestyle, more than half of Hong Kong's children and young people fail to follow the current physical activity recommendations, and trends show a decline in health-related physical fitness. Executive functions develop from early childhood and through adolescence into adulthood, with large developmental changes occurring during the elementary school years. Accordingly, effective interventions implemented early in life when the higher cortex is still developing, have the potential to elicit significant long-term improvements. Therefore, it is important to find effective strategies to promote the PA of children, so as to improve their executive function during their childhood.
Attention-deficit/hyperactivity disorder (ADHD) is a commonly diagnosed developmental disorder, with a 5.3% worldwide prevalence in children and adolescents. The most common symptoms include inattention, impulsivity, impaired inhibition, and hyperactivity. Also, young people with ADHD are often characterized by dysfunction in high-level cognitive functions such as executive function. This executive dysfunction may play an important role in the commonly observed behavioral problems in children with ADHD. There are a number of ways to treat ADHD, e.g., medication, psychotherapy, psychoeducation, neuro-feedback, behavior management, etc. Of these treatments, PA and exercise have emerged as effective strategies to manage ADHD given that neither are associated with negative side effects (see recent reviews. To summarize, although not always consistently, PA, especially moderate- to high-intensity aerobic exercise, may improve the emotion/mood, behavior, executive function, and some physical measures of children with ADHD. Acute aerobic exercise may have a positive effect on a variety of measures with a large effect size up to 1.26 in children with ADHD. Two studies have reported medium-to-large effects of acute exercise on executive function. Long-term exercise interventions have also been shown to benefit children with ADHD, with improvements in some measures showing a large effect size up to 0.96. However, these benefits have been mainly described as an improvement of behavioral and emotional problems. Several studies have reported that long-term 'mixed exercise programs' may have moderate to significant effects on several aspects of executive function (e.g., inhibition) and attention in children and adolescents with ADHD, but other studies did not report the same findings. Therefore, so far evidence-based suggestions regarding the optimal exercise for children with ADHD remain somewhat inconsistent.
Research into the relationship between PA and ADHD has generally involved mixed exercise programs at a low- to moderate-intensity; running and stationary cycling have been the most common exercise modes. Whether structured PA is effective for young people is yet to be examined. Children's habitual PA patterns are characterized by participation in games or "unpredictable" sports activities (e.g., football, basketball). Given that children's intrinsic motivation, or level of enjoyment, is also a strong predictor of PA participation, any intervention program should be designed to optimize their enjoyment of PA and thus enhance the likelihood of long-term adherence. When compared to structured exercises such as running or cycling, games-based PA arguably provides a more attractive, acceptable, sustainable, and enjoyable exercise model for young children. To date, only a few studies have examined the effect of an acute bout of team game-based activity on cognitive function in healthy children and adolescents. Research has found that different aspects of cognitive function, such as free recall memory, attention, executive function, and working memory are improved following an acute bout of game-based team exercise (e.g., basketball, tennis). For children with ADHD, mixed exercise protocols have generally been used in intervention programs, and only a few studies have used team sport-based games as part of their exercise intervention. However, given the design of these studies, it is not possible to distinguish the sole effect of game-based PA from those of the mixed exercise protocols in these studies. A recent study has reported that a 12-week table tennis exercise has positive effects on the gross motor skills and some of the executive function performances (mainly inhibition) in the ADHD training group, compared with the ADHD non-training group and a control group. It should be noted that the game-based PA in these aforementioned studies was generally 'aerobic' in nature and completed at low- to moderate intensities.
Recently high-intensity interval training (HIIT) has emerged as a feasible and efficacious strategy for improving the physical health of young people. The HIIT can be completed in a short period of time while resulting in equivalent physiological adaptations to longer sessions of traditional aerobic training. Recent research has suggested that traditional HIIT intervention programs, including running and cycling, may improve executive function in healthy children and adolescents. It has been suggested that a very brief HIIT intervention over two weeks reduced off-task behavior and enhanced selective attention in primary school children. For children with ADHD, to the best of our knowledge, only one recent study was conducted to investigate the effect of a traditional HIIT program on physical fitness, motor skills, social behavior, and quality of life. In this randomized controlled trial, 28 boys with ADHD were assigned to either a traditional HIIT group or a standard multimodal therapy (TRAD) group. After the three-week intervention, the authors reported that HIIT was more effective in improving motor skills, self-esteem, relations with friends, competence, and subjective ratings of attention, compared with TRAD. However, despite this encouraging preliminary evidence, it remains unclear whether HIIT can be adapted to treat children with ADHD to improve their executive function, a key aspect in many facets of life.
While the limited findings regarding the effects of HIIT on executive function are encouraging, and HIIT has emerged as an enjoyable and effective exercise for children, previous studies have tended to prescribe HIIT interventions with a focus on running and jumping. The effect of game-based HIIT interventions on the executive function of children has yet to be investigated. Research of this nature is needed, particularly to determine whether game-based HIIT can improve outcomes (e.g., executive function, social behavior, sports skills, etc.) for children with ADHD. Therefore, the aim of the proposed study is to investigate the effect of two different kinds of exercise programs, i.e., an 8-week game-based HIIT (GameHIIT) program and an 8-week game-based structured aerobic exercise (GameSAE) program, on the executive function of children with ADHD. The hypothesis of the proposed study is that both GameHIIT and GameSAE programs will significantly improve the executive function of children with ADHD, compared with those in the control group. A secondary hypothesis is that the GameHIIT group may confer additional benefits when compared with the GameSAE group.
- Being tested
- Game-based High-Intensity Interval Training, GameSAE
- Keywords
- Special education need, Physical activity, fNIRS
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-based High-Intensity Interval TrainingOther
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.
GameSAEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: GameSAE |
| Control group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Secondary outcomes (40)
Body height
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.
Measured: The measurements are assessed at baseline (T0).
Body height
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.
Measured: The measurements are assessed after the 8-week intervention period (T1).
Body height
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.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Body weight
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.
Measured: The measurements are assessed at baseline (T0).
Body weight
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.
Measured: The measurements are assessed after the 8-week intervention period (T1).
Body weight
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.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Waist circumference
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).
Measured: The measurements are assessed at baseline (T0).
Waist circumference
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).
Measured: The measurements are assessed after the 8-week intervention period (T1).
Waist circumference
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).
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Hip circumference
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).
Measured: The measurements are assessed at baseline (T0).
Hip circumference
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).
Measured: The measurements are assessed after the 8-week intervention period (T1).
Hip circumference
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).
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Measured: The measurements are assessed at baseline (T0).
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Measured: The measurements are assessed after the 8-week intervention period (T1).
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Social Behavior
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.
Measured: The measurements are assessed at baseline (T0).
Social Behavior
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.
Measured: The measurements are assessed after the 8-week intervention period (T1).
Social Behavior
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.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Overall ADHD Symptoms
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'.
Measured: The measurements are assessed at baseline (T0).
Overall ADHD Symptoms
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'.
Measured: The measurements are assessed after the 8-week intervention period (T1).
Overall ADHD Symptoms
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'.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Moderate-to-Vigorous Physical Activity (MVPA)
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).
Measured: The measurements are assessed at baseline (T0).
Moderate-to-Vigorous Physical Activity (MVPA)
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).
Measured: The measurements are assessed after the 8-week intervention period (T1).
Moderate-to-Vigorous Physical Activity (MVPA)
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).
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Self-reported Physical Activity
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).
Measured: The measurements are assessed at baseline (T0).
Self-reported Physical Activity
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).
Measured: The measurements are assessed after the 8-week intervention period (T1).
Self-reported Physical Activity
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).
Measured: The measurements are assessed after the 8-week intervention period and another 8-week follow up (T2).
Enjoyment
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.
Measured: The measurements are assessed at baseline (T0).
Enjoyment
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.
Measured: The measurements are assessed after the 8-week intervention period (T1).
Enjoyment
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.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Adherence
Adherence to the intervention program will be evaluated by attendance frequency and dropout rate.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Physical Fitness (cardiovascular fitness)
The cardiovascular fitness will be assessed by the 20 m shuttle run test using the ALPHA fitness test battery.
Measured: The measurements are assessed at baseline (T0).
Physical Fitness (cardiovascular fitness)
The cardiovascular fitness will be assessed by the 20 m shuttle run test using the ALPHA fitness test battery.
Measured: The measurements are assessed after the 8-week intervention period (T1).
Physical Fitness (cardiovascular fitness)
The cardiovascular fitness will be assessed by the 20 m shuttle run test using the ALPHA fitness test battery.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Physical Fitness (muscular strength)
The muscular strength will be assessed by the handgrip strength test and standing long jump test using the ALPHA fitness test battery.
Measured: The measurements are assessed at baseline (T0).
Physical Fitness (muscular strength)
The muscular strength will be assessed by the handgrip strength test and standing long jump test using the ALPHA fitness test battery.
Measured: The measurements are assessed after the 8-week intervention period (T1).
Physical Fitness (muscular strength)
The muscular strength will be assessed by the handgrip strength test and standing long jump test using the ALPHA fitness test battery.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Physical Fitness (speed-agility)
The speed-agility will be assessed by the 4 × 10 m shuttle run test using the ALPHA fitness test battery.
Measured: The measurements are assessed at baseline (T0).
Physical Fitness (speed-agility)
The speed-agility will be assessed by the 4 × 10 m shuttle run test using the ALPHA fitness test battery.
Measured: The measurements are assessed after the 8-week intervention period (T1).
Physical Fitness (speed-agility)
The speed-agility will be assessed by the 4 × 10 m shuttle run test using the ALPHA fitness test battery.
Measured: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Adhd Deficits in Attention Motor Control and PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fenghua Sun, Dotcor, Study director, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308758
- Sponsor's protocol ID
- EdUHK 18603120
- Status last verified
- May 2024
- First submitted
- 17 Feb 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janssen I, Leblanc AG. Systematic review of the health benefits of physical activity and fitness in school-aged children and youth. Int J Behav Nutr Phys Act. 2010 May 11;7:40. doi: 10.1186/1479-5868-7-40.
PubMed 20459784Parfitt G, Eston RG. The relationship between children's habitual activity level and psychological well-being. Acta Paediatr. 2005 Dec;94(12):1791-7. doi: 10.1111/j.1651-2227.2005.tb01855.x.
PubMed 16421041Hillman CH, Erickson KI, Kramer AF. Be smart, exercise your heart: exercise effects on brain and cognition. Nat Rev Neurosci. 2008 Jan;9(1):58-65. doi: 10.1038/nrn2298.
PubMed 18094706Alvarez JA, Emory E. Executive function and the frontal lobes: a meta-analytic review. Neuropsychol Rev. 2006 Mar;16(1):17-42. doi: 10.1007/s11065-006-9002-x.
PubMed 16794878Kramer AF, Humphrey DG, Larish JF, Logan GD, Strayer DL. Aging and inhibition: beyond a unitary view of inhibitory processing in attention. Psychol Aging. 1994 Dec;9(4):491-512.
PubMed 7893421Pennington BF, Ozonoff S. Executive functions and developmental psychopathology. J Child Psychol Psychiatry. 1996 Jan;37(1):51-87. doi: 10.1111/j.1469-7610.1996.tb01380.x.
PubMed 8655658Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
PubMed 23020641Moffitt TE, Arseneault L, Belsky D, Dickson N, Hancox RJ, Harrington H, Houts R, Poulton R, Roberts BW, Ross S, Sears MR, Thomson WM, Caspi A. A gradient of childhood self-control predicts health, wealth, and public safety. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):2693-8. doi: 10.1073/pnas.1010076108. Epub 2011 Jan 24.
PubMed 21262822Verburgh L, Konigs M, Scherder EJ, Oosterlaan J. Physical exercise and executive functions in preadolescent children, adolescents and young adults: a meta-analysis. Br J Sports Med. 2014 Jun;48(12):973-9. doi: 10.1136/bjsports-2012-091441. Epub 2013 Mar 6.
PubMed 23467962Alvarez-Bueno C, Pesce C, Cavero-Redondo I, Sanchez-Lopez M, Martinez-Hortelano JA, Martinez-Vizcaino V. The Effect of Physical Activity Interventions on Children's Cognition and Metacognition: A Systematic Review and Meta-Analysis. J Am Acad Child Adolesc Psychiatry. 2017 Sep;56(9):729-738. doi: 10.1016/j.jaac.2017.06.012. Epub 2017 Jul 6.
PubMed 28838577Huang WY, Wong SHS, Sit CHP, Wong MCS, Sum RKW, Wong SWS, Yu JJ. Results from the Hong Kong's 2018 report card on physical activity for children and youth. J Exerc Sci Fit. 2019 Jan;17(1):14-19. doi: 10.1016/j.jesf.2018.10.003. Epub 2018 Oct 8.
PubMed 30662509Mak KK, Day JR. Secular trends of sports participation, sedentary activity and physical self-perceptions in Hong Kong adolescents, 1995-2000. Acta Paediatr. 2010 Nov;99(11):1731-4. doi: 10.1111/j.1651-2227.2010.01928.x. Epub 2010 Jul 13.
PubMed 20586996Blakemore SJ, Choudhury S. Development of the adolescent brain: implications for executive function and social cognition. J Child Psychol Psychiatry. 2006 Mar-Apr;47(3-4):296-312. doi: 10.1111/j.1469-7610.2006.01611.x.
PubMed 16492261Zelazo PD, Craik FI, Booth L. Executive function across the life span. Acta Psychol (Amst). 2004 Feb-Mar;115(2-3):167-83. doi: 10.1016/j.actpsy.2003.12.005.
PubMed 14962399Best JR, Miller PH, Jones LL. Executive Functions after Age 5: Changes and Correlates. Dev Rev. 2009 Sep 1;29(3):180-200. doi: 10.1016/j.dr.2009.05.002.
PubMed 20161467
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05308758
- Acronym / sponsor ID
- EdUHK 18603120
- Keywords
- Special education need, Physical activity, fNIRS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Detailed description
There is strong evidence that regular physical activity (PA) is associated with a range of physical health benefits for school-age youth, including improvements in body composition, physical capacity, and overall health-related indicators (e.g., blood pressure, insulin resistance, lipid profile). Emerging evidence also suggests that PA and physical fitness have a positive effect on mental health, cognitive function, and academic performance. Executive functions are generally defined as "high-level cognitive processes" that manage other basic cognitive functions. They consist of functions such as planning, self-regulation, initiation and inhibition, and cognitive flexibility. These functions are believed to be important prerequisites for successful learning in preadolescent children, predict better health and wealth, and have been associated with a reduced likelihood of being convicted of a criminal offense. Several recent meta-analyses have suggested that PA may positively affect cognition and executive function in children. Despite the known benefits of an active lifestyle, more than half of Hong Kong's children and young people fail to follow the current physical activity recommendations, and trends show a decline in health-related physical fitness. Executive functions develop from early childhood and through adolescence into adulthood, with large developmental changes occurring during the elementary school years. Accordingly, effective interventions implemented early in life when the higher cortex is still developing, have the potential to elicit significant long-term improvements. Therefore, it is important to find effective strategies to promote the PA of children, so as to improve their executive function during their childhood.
Attention-deficit/hyperactivity disorder (ADHD) is a commonly diagnosed developmental disorder, with a 5.3% worldwide prevalence in children and adolescents. The most common symptoms include inattention, impulsivity, impaired inhibition, and hyperactivity. Also, young people with ADHD are often characterized by dysfunction in high-level cognitive functions such as executive function. This executive dysfunction may play an important role in the commonly observed behavioral problems in children with ADHD. There are a number of ways to treat ADHD, e.g., medication, psychotherapy, psychoeducation, neuro-feedback, behavior management, etc. Of these treatments, PA and exercise have emerged as effective strategies to manage ADHD given that neither are associated with negative side effects (see recent reviews. To summarize, although not always consistently, PA, especially moderate- to high-intensity aerobic exercise, may improve the emotion/mood, behavior, executive function, and some physical measures of children with ADHD. Acute aerobic exercise may have a positive effect on a variety of measures with a large effect size up to 1.26 in children with ADHD. Two studies have reported medium-to-large effects of acute exercise on executive function. Long-term exercise interventions have also been shown to benefit children with ADHD, with improvements in some measures showing a large effect size up to 0.96. However, these benefits have been mainly described as an improvement of behavioral and emotional problems. Several studies have reported that long-term 'mixed exercise programs' may have moderate to significant effects on several aspects of executive function (e.g., inhibition) and attention in children and adolescents with ADHD, but other studies did not report the same findings. Therefore, so far evidence-based suggestions regarding the optimal exercise for children with ADHD remain somewhat inconsistent.
Research into the relationship between PA and ADHD has generally involved mixed exercise programs at a low- to moderate-intensity; running and stationary cycling have been the most common exercise modes. Whether structured PA is effective for young people is yet to be examined. Children's habitual PA patterns are characterized by participation in games or "unpredictable" sports activities (e.g., football, basketball). Given that children's intrinsic motivation, or level of enjoyment, is also a strong predictor of PA participation, any intervention program should be designed to optimize their enjoyment of PA and thus enhance the likelihood of long-term adherence. When compared to structured exercises such as running or cycling, games-based PA arguably provides a more attractive, acceptable, sustainable, and enjoyable exercise model for young children. To date, only a few studies have examined the effect of an acute bout of team game-based activity on cognitive function in healthy children and adolescents. Research has found that different aspects of cognitive function, such as free recall memory, attention, executive function, and working memory are improved following an acute bout of game-based team exercise (e.g., basketball, tennis). For children with ADHD, mixed exercise protocols have generally been used in intervention programs, and only a few studies have used team sport-based games as part of their exercise intervention. However, given the design of these studies, it is not possible to distinguish the sole effect of game-based PA from those of the mixed exercise protocols in these studies. A recent study has reported that a 12-week table tennis exercise has positive effects on the gross motor skills and some of the executive function performances (mainly inhibition) in the ADHD training group, compared with the ADHD non-training group and a control group. It should be noted that the game-based PA in these aforementioned studies was generally 'aerobic' in nature and completed at low- to moderate intensities.
Recently high-intensity interval training (HIIT) has emerged as a feasible and efficacious strategy for improving the physical health of young people. The HIIT can be completed in a short period of time while resulting in equivalent physiological adaptations to longer sessions of traditional aerobic training. Recent research has suggested that traditional HIIT intervention programs, including running and cycling, may improve executive function in healthy children and adolescents. It has been suggested that a very brief HIIT intervention over two weeks reduced off-task behavior and enhanced selective attention in primary school children. For children with ADHD, to the best of our knowledge, only one recent study was conducted to investigate the effect of a traditional HIIT program on physical fitness, motor skills, social behavior, and quality of life. In this randomized controlled trial, 28 boys with ADHD were assigned to either a traditional HIIT group or a standard multimodal therapy (TRAD) group. After the three-week intervention, the authors reported that HIIT was more effective in improving motor skills, self-esteem, relations with friends, competence, and subjective ratings of attention, compared with TRAD. However, despite this encouraging preliminary evidence, it remains unclear whether HIIT can be adapted to treat children with ADHD to improve their executive function, a key aspect in many facets of life.
While the limited findings regarding the effects of HIIT on executive function are encouraging, and HIIT has emerged as an enjoyable and effective exercise for children, previous studies have tended to prescribe HIIT interventions with a focus on running and jumping. The effect of game-based HIIT interventions on the executive function of children has yet to be investigated. Research of this nature is needed, particularly to determine whether game-based HIIT can improve outcomes (e.g., executive function, social behavior, sports skills, etc.) for children with ADHD. Therefore, the aim of the proposed study is to investigate the effect of two different kinds of exercise programs, i.e., an 8-week game-based HIIT (GameHIIT) program and an 8-week game-based structured aerobic exercise (GameSAE) program, on the executive function of children with ADHD. The hypothesis of the proposed study is that both GameHIIT and GameSAE programs will significantly improve the executive function of children with ADHD, compared with those in the control group. A secondary hypothesis is that the GameHIIT group may confer additional benefits when compared with the GameSAE group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GameHIIT intervention group | Experimental | Other: Game-based High-Intensity Interval TrainingIn the GameHIIT group, a specially designed game-based training program with HIIT in nature will be delivered to the participants for 8 weeks. |
| GameSE intervention group | Active comparator | Other: GameSAEIn 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. |
| Control group | No intervention | –No intervention. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of ADHD
- Must be able to participate in physical activity
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game-based High-Intensity Interval TrainingThere 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. | Other | GameHIIT intervention group |
| GameSAESimilar 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. | Other | GameSE intervention group |
Primary outcome
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.
40 secondary outcomes
Body height
Time frame: The measurements are assessed at baseline (T0).
Body height
Time frame: The measurements are assessed after the 8-week intervention period (T1).
Body height
Time frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Body weight
Time frame: The measurements are assessed at baseline (T0).
Body weight
Time frame: The measurements are assessed after the 8-week intervention period (T1).
Body weight
Time frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Waist circumference
Time frame: The measurements are assessed at baseline (T0).
Waist circumference
Time frame: The measurements are assessed after the 8-week intervention period (T1).
Waist circumference
Time frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Hip circumference
Time frame: The measurements are assessed at baseline (T0).
Hip circumference
Time frame: The measurements are assessed after the 8-week intervention period (T1).
Hip circumference
Time frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Body mass index (BMI)
Time frame: The measurements are assessed at baseline (T0).
Body mass index (BMI)
Time frame: The measurements are assessed after the 8-week intervention period (T1).
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).
Social Behavior
Time frame: The measurements are assessed at baseline (T0).
Social Behavior
Time frame: The measurements are assessed after the 8-week intervention period (T1).
Social Behavior
Time frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Overall ADHD Symptoms
Time frame: The measurements are assessed at baseline (T0).
Overall ADHD Symptoms
Time frame: The measurements are assessed after the 8-week intervention period (T1).
Overall ADHD Symptoms
Time frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: The measurements are assessed at baseline (T0).
Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: The measurements are assessed after the 8-week intervention period (T1).
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).
Self-reported Physical Activity
Time frame: The measurements are assessed at baseline (T0).
Self-reported Physical Activity
Time frame: The measurements are assessed after the 8-week intervention period (T1).
Self-reported Physical Activity
Time frame: The measurements are assessed after the 8-week intervention period and another 8-week follow up (T2).
Enjoyment
Time frame: The measurements are assessed at baseline (T0).
Enjoyment
Time frame: The measurements are assessed after the 8-week intervention period (T1).
Enjoyment
Time frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Adherence
Time frame: The measurements are assessed after the 8-week intervention period, as well as another 8-week follow up (T2).
Physical Fitness (cardiovascular fitness)
Time frame: The measurements are assessed at baseline (T0).
Physical Fitness (cardiovascular fitness)
Time frame: The measurements are assessed after the 8-week intervention period (T1).
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).
Physical Fitness (muscular strength)
Time frame: The measurements are assessed at baseline (T0).
Physical Fitness (muscular strength)
Time frame: The measurements are assessed after the 8-week intervention period (T1).
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).
Physical Fitness (speed-agility)
Time frame: The measurements are assessed at baseline (T0).
Physical Fitness (speed-agility)
Time frame: The measurements are assessed after the 8-week intervention period (T1).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 20459784Janssen I, Leblanc AG. Systematic review of the health benefits of physical activity and fitness in school-aged children and youth. Int J Behav Nutr Phys Act. 2010 May 11;7:40. doi: 10.1186/1479-5868-7-40.
- Background: PubMed 16421041Parfitt G, Eston RG. The relationship between children's habitual activity level and psychological well-being. Acta Paediatr. 2005 Dec;94(12):1791-7. doi: 10.1111/j.1651-2227.2005.tb01855.x.
- Background: PubMed 18094706Hillman CH, Erickson KI, Kramer AF. Be smart, exercise your heart: exercise effects on brain and cognition. Nat Rev Neurosci. 2008 Jan;9(1):58-65. doi: 10.1038/nrn2298.
- Background: PubMed 16794878Alvarez JA, Emory E. Executive function and the frontal lobes: a meta-analytic review. Neuropsychol Rev. 2006 Mar;16(1):17-42. doi: 10.1007/s11065-006-9002-x.
- Background: PubMed 7893421Kramer AF, Humphrey DG, Larish JF, Logan GD, Strayer DL. Aging and inhibition: beyond a unitary view of inhibitory processing in attention. Psychol Aging. 1994 Dec;9(4):491-512.
- Background: PubMed 8655658Pennington BF, Ozonoff S. Executive functions and developmental psychopathology. J Child Psychol Psychiatry. 1996 Jan;37(1):51-87. doi: 10.1111/j.1469-7610.1996.tb01380.x.
- Background: PubMed 23020641Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- Background: PubMed 21262822Moffitt TE, Arseneault L, Belsky D, Dickson N, Hancox RJ, Harrington H, Houts R, Poulton R, Roberts BW, Ross S, Sears MR, Thomson WM, Caspi A. A gradient of childhood self-control predicts health, wealth, and public safety. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):2693-8. doi: 10.1073/pnas.1010076108. Epub 2011 Jan 24.
- Background: PubMed 23467962Verburgh L, Konigs M, Scherder EJ, Oosterlaan J. Physical exercise and executive functions in preadolescent children, adolescents and young adults: a meta-analysis. Br J Sports Med. 2014 Jun;48(12):973-9. doi: 10.1136/bjsports-2012-091441. Epub 2013 Mar 6.
- Background: PubMed 28838577Alvarez-Bueno C, Pesce C, Cavero-Redondo I, Sanchez-Lopez M, Martinez-Hortelano JA, Martinez-Vizcaino V. The Effect of Physical Activity Interventions on Children's Cognition and Metacognition: A Systematic Review and Meta-Analysis. J Am Acad Child Adolesc Psychiatry. 2017 Sep;56(9):729-738. doi: 10.1016/j.jaac.2017.06.012. Epub 2017 Jul 6.
- Background: PubMed 30662509Huang WY, Wong SHS, Sit CHP, Wong MCS, Sum RKW, Wong SWS, Yu JJ. Results from the Hong Kong's 2018 report card on physical activity for children and youth. J Exerc Sci Fit. 2019 Jan;17(1):14-19. doi: 10.1016/j.jesf.2018.10.003. Epub 2018 Oct 8.
- Background: PubMed 20586996Mak KK, Day JR. Secular trends of sports participation, sedentary activity and physical self-perceptions in Hong Kong adolescents, 1995-2000. Acta Paediatr. 2010 Nov;99(11):1731-4. doi: 10.1111/j.1651-2227.2010.01928.x. Epub 2010 Jul 13.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fenghua Sun, Dotcor study director
The Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game-based High-Intensity Interval Training and GameSAE in people with Adhd Deficits in Attention Motor Control and Perception, run by Education University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colour-Word Stroop Test (CWST) (time frame: The measurements are assessed at baseline (T0).). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05308758, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.