ADHDNCT05668195
Systematic Aerobics and Intelligent Monitoring System in Executive Skill Training for School-aged Children With ADHD
A study testing systematic aerobic exercise and intelligent monitoring system in executive skill training and executive skill training in people with ADHD, run by Chen Li at 1 site in China.
Trial summary
Around 7.2% of children around the world are suffering from Attention Deficit Hyperactivity Disorder (ADHD). Systematic executive skill training for children is currently recognized as one of the main programs for psychosocial behavioral interventions in ADHD, but the theoretical basis for the 1 hour "play class"… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- systematic aerobic exercise and intelligent monitoring system in executive skill training and executive skill training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2022to 31 Dec 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnose of ADHD according to DSM-5
- Aged 6-12 years
- Children receiving methylphenidate are required to be titrated to a stable dose before training, and those who did not change medication, stop medication, or adjust dose during training are included in the analysis
Who cannot join
- IQ≤80
- Inconsistent or changing dose of methylphenidate during the participation period
- Suffering from organic lesions of nervous system now or in the past
- Suffering from epilepsy, autism spectrum disorder and other severe neurodevelopmental behavioral disorders now or in the past
- Not suitable for medium to high intensity aerobic training
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Growth, Development and Mental health of Children and Adolescence Center
Chongqing, Chongqing Municipality, 400014
Li Chen, MD, (+86)136 7762 0103 ext. +86, chenli2012@126.com
About this study
Official title: Research and Promotion of Systematic Aerobic Exercise and Intelligent Monitoring System in Executive Skill Training for School-aged Children With Attention Deficit Hyperactivity Disorder
Around 7.2% of children around the world are suffering from Attention Deficit Hyperactivity Disorder (ADHD). Systematic executive skill training for children is currently recognized as one of the main programs for psychosocial behavioral interventions in ADHD, but the theoretical basis for the 1 hour "play class" component of the 3 hours per week children's classroom is insufficient. We have developed a closed-loop moderate-intensity aerobic training system, which is combined with an intelligent monitoring system, to further standardize and improve the treatment and management of ADHD intervention. The intelligent monitoring system in this study includes physiological intelligent monitoring (heart rate data) and psychological and behavioral intelligent monitoring (based on the computerized "adaptive" executive function testing procedures and clinical questionnaire scale). 200 subjects aged 6-12 years with a diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria are randomly assigned into two groups to receive executive skill training and systematic aerobic exercise and intelligent monitoring system, or systematic executive skill training for 13 weeks. Symptoms severity is assessed by Vanderbilt Assessment Scales at weeks 0, 6, and 13. Subjects' executive function is assessed using executive function tests before and after training, parental depression/anxiety assessment, family environment assessment, and monitoring of heart rate during exercise are also included. All the other sociodemographic data are assessed. This study will investigate the effects of systematic aerobic exercise and intelligent monitoring system in executive skill training on the promotion of cold executive functions such as responsiveness, flexibility, and inhibition and hot executive functions such as reward mechanisms in children, and their effects on children with ADHD and their families.
Read the detailed description
- Procedures. The children in the group are randomly divided into a test group and a control group, and further divided into 4 groups according to whether they were also treated with medication (methylphenidate) or not. Children receiving methylphenidate are required to be titrated to a stable dose before training, and those who did not change medication, stop medication, or adjust dose during training are included in the analysis. The children will be trained for 13 weeks, and the children with ADHD will be evaluated for symptoms and functions, parenting stress, and family environment at training weeks 0, 6, and 13, respectively; the children will be tested for executive function at training weeks 0 and 13; and the children with ADHD will be monitored for basic vital indicators.
- Demographic questionnaire and clinical data. The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, blood pressure, heart rate. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis, disease classification, current treatment, and comorbid conditions.
- Sample size. This study is a randomized controlled trial. Intervention group receives executive skill training and systematic aerobic exercise and intelligent monitoring system, control group receives systematic executive skill training. The primary outcome index is changes in ADHD symptoms evaluated by Vanderbilt Assessment Scales and changes in executive functions evaluated by executive function tests such as Stop-Signal task, GO/NO-GO task reflecting response control, Simon task reflecting conflict control, Dimensional Change Card Sorting (DCCS) task reflecting cognitive flexibility, and N-Back task reflecting working memory. Self-rating depression scale, self-rating anxiety scale are used to assess parental emotions, family environment scale-Chinese version is used to assess family environment. The child wears a heart rate band to monitor heart rate changes during exercise and the data is collected and analyzed in the background. Since this study is pioneering, the investigators artificially set the sample size at 200.
- Statistical analysis. All the data are analyzed using SPSS 25.0. The normality of variables are assessed by Kolmogorov Smirnov test. Comparison of parametric and nonparametric variables between groups are examined by F test and Kruskal-Wallis test, respectively. Paired t-test and Wilcoxon signed-rank test are used to investigate within-group differences. Confounding factors are adjusted by the analysis of covariance.
- Ethical matters and data protection. The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
- Conditions
- ADHD
- Being tested
- systematic aerobic exercise and intelligent monitoring system in executive skill training, executive skill training
- Keywords
- ADHD, Executive Skill Training, Aerobic Exercise
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic aerobic exercise and intelligent monitoring system in executive skill trainingProcedure or surgery
This is a closed-loop training initially developed by the research team in conjunction with other teams, adding a systematic aerobic exercise and intelligent monitoring system to the typical executive skill training, and is being further explored in training.
executive skill trainingProcedure or surgery
The training program, based on Dawson and Guare's (2010) training of executive skills for children, aimed to improve the everyday performance of executive skills among children with ADHD. Qian Y and her team added some culturally adapted information, following the theory of cognitive behavioral therapy, to ensure that the concepts were acceptable to Chinese children.
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise group | Experimental | The patients aged 6-12 with a diagnose of ADHD of this group receive systematic aerobic exercise and intelligent monitoring system in executive skill training for 13 weeks, including those taking methylphenidate or not. Receives: Procedure: systematic aerobic exercise and intelligent monitoring system in executive skill training; Procedure: executive skill training |
| executive skill training group | Active comparator | The patients aged 6-12 with a diagnose of ADHD of this group receive executive skill training for 13 weeks, including those taking methylphenidate or not. Receives: Procedure: executive skill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in ADHD clinical symptoms-Estimated by Chinese version of Vanderbilt parent/teacher diagnostic scale
The Vanderbilt parent/teacher diagnostic scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56/36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.
The scoring standard: Must score a 2 or 3 on 6 out of 9 items on questions 1-9(Predominantly Inattentive subtype)/10-18(Predominantly Hyperactive/Impulsive subtype)/both 1-9 and 10-18(ADHD Combined Inattention/Hyperactivity) AND Score a 4 or 5 on any of the Performance questions 49-56(parent)/36-43(teacher). The higher scores mean a worse outcome.
Measured: at weeks 0 for the children with first diagnosis of ADHD
The changes in ADHD clinical symptoms-Estimated by Chinese version of Vanderbilt parent/teacher follow-up scale
The Vanderbilt parent/teacher follow-up scale is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).
The scoring standard: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
Measured: at weeks 0, 6 and 13
False alarms of GO/NO-GO task
GO/NO-GO task reflects response inhibition. Subjects are required to press a button when a certain stimulus appeared on the screen (e.g., a circle) and not when some other stimulus appeared (e.g., a triangle), with the majority of stimuli requiring a button (≥75%) and a small percentage of stimuli not requiring a button (≤25%). The false alarms are the numbers of stimuli to which subjects responded incorrectly that did not require a response.
Measured: at weeks 0 and 13
The correct rate of GO/NO-GO task
GO/NO-GO task reflects response inhibition. Subjects are required to press a button when a certain stimulus appeared on the screen (e.g., a circle) and not when some other stimulus appeared (e.g., a triangle), with the majority of stimuli requiring a button (≥75%) and a small percentage of stimuli not requiring a button (≤25%). We will calculate the correct rate.
Measured: at weeks 0 and 13
The correct rate of Stop-signal task
Similar to GO/NO-GO task, Stop-signal task also reflects response inhibition. The "GO" signal presents every time, but in a few instances the "GO" signal is followed by a "Stop" signal, when the subject was asked not to press the button. The majority of stimuli (≥75%) require to press a button, while the "GO" signal followed by a "Stop" signal is ≤25%. We will calculate the correct rate.
Measured: at weeks 0 and 13
The correct rate of Simon task
Simon task reflects interference control. When subjects see stimulus A, press the left button (L); when they see stimulus B, press the right button (R). Stimuli A and B may appear in different directions. We will calculate the correct rate.
Measured: at weeks 0 and 13
The number of correct switches of DCCS task
DCCS task reflects cognitive flexibility. Subjects are presented with a set of stimulus pictures with different dimensions (such as shape, number and color) and test pictures that can be matched with different stimulus pictures in different dimensions. Subjects need to classify the current stimulus according to different rules. When the rules change, they need to adjust their reactions as soon as possible and change the classification way. The number of correct switches refers to the number of times the subject continuously makes the correct response when the classification rule is changed.
Measured: at weeks 0 and 13
The correct rate of DCCS task
DCCS task reflects cognitive flexibility. Subjects are presented with a set of stimulus pictures with different dimensions (such as shape, number and color) and test pictures that can be matched with different stimulus pictures in different dimensions. Subjects need to classify the current stimulus according to different rules. When the rules change, they need to adjust their reactions as soon as possible and change the classification way. We will calculate the correct rate.
Measured: at weeks 0 and 13
The hit rate and the false alarm rate of N-back task
N-back task reflects working memory. The subjects are presented with a series of stimuli and asked to compare the current stimulus with the Nth stimulus backwards. If the two stimuli are the same, it is the target; if they are different, it is the non-target. The hit rate means that the subject responds correctly to the target, and the false alarm rate means that the subject responds incorrectly to the non-target.
Measured: at weeks 0 and 13
Secondary outcomes (4)
The changes of parental mood-Estimated by Self-rating depression scale (SDS)
The Self-Rating Depression Scale (SDS) consists of 20 items with a Likert type scale after each item. The scores for each item range from 1 to 4 and the SDS ranges from a raw score of 20 to a raw score of 80. Some items are reverse scored (i.e., they go from 4 down to 1). SDS scores are classified as normal (<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (>70). The raw score can be converted to an SDS Index score by multiplying the raw score times 1.25.
Measured: at weeks 0, 6 and 13
The changes of parental mood-Estimated by Self-rating anxiety scale (SAS)
The SAS groups anxiety manifestations into cognitive, autonomic, motor, and central nervous system symptoms. Each of the 20 items is answered on a four-point Likert scale ranging from 1 to 4:1 - A little of the time, 2 - Some of the time, 3 - A good part of the time, 4 - Most of the time. A person's score is calculated by adding up all the values selected. Higher scores indicate greater levels of anxiety. According to Zung, the total raw scores are converted to an anxiety index number using a conversion chart. The anxiety index numbers are interpreted as follows: Less than 45: Normal range, 45-59: Mild to moderate anxiety levels, 60-74: Marked to severe anxiety levels, 75-80: Extreme anxiety levels.
Measured: at weeks 0, 6 and 13
The changes of family environment-Estimated by Family environment scale-Chinese version (FES-CV)
The Family Environment Scale is a 90 item measure that evaluates the social environment of the family unit. Three forms are available: the Real Form (Form R), which measures the family environment as it is; the Ideal Form (Form I) which measures the family environment as it would be in a perfect situation; and the Expected Form (Form E), which measures the family environment as it will probably be in new situations. The FES is composed of ten subscales that measure the underlying dimensions of Family Relationship, Personal Growth and System Maintenance and Change.
Measured: at weeks 0, 6 and 13
The changes in heart rate
Heart rate (or pulse rate) is the frequency of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm). When the children are doing aerobic exercise, we monitor the changes of heart rate and analysis.
Measured: during the class of aerobic exercise, about 40min per class, once a week, 13weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start24 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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
- Model description
- The children in the group are randomly divided into a test group and a control group, and further divided into 4 groups according to whether they were also treated with medication (methylphenidate) or not. Children receiving methylphenidate are required to be titrated to a stable dose before training, and those who did not change medication, stop medication, or adjust dose during training are included in the analysis. The test group receive systematic aerobic exercise and intelligent monitoring system in executive skill training, the control group receive systematic executive skill training, for 13 weeks. The research team, together with other teams, has initially developed a set of closed-loop training and is further exploring it in training.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Li
- Sponsor type
- University, hospital or other
- Collaborators
- Southwest University, China
- Responsible party
- Sponsor-investigator, Chen Li, Children's Hospital of Chongqing Medical University
- Investigators
- Li Chen, doctor, Study director, Children's Hospital of Chongqing Medical Universityyu T Li, MS, Study chair, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668195
- Sponsor's protocol ID
- AEIMS
- Status last verified
- Feb 2023
- First submitted
- 9 Dec 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is confidential during the study.
Publications
Wolraich ML, Hagan JF Jr, Allan C, Chan E, Davison D, Earls M, Evans SW, Flinn SK, Froehlich T, Frost J, Holbrook JR, Lehmann CU, Lessin HR, Okechukwu K, Pierce KL, Winner JD, Zurhellen W; SUBCOMMITTEE ON CHILDREN AND ADOLESCENTS WITH ATTENTION-DEFICIT/HYPERACTIVE DISORDER. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019 Oct;144(4):e20192528. doi: 10.1542/peds.2019-2528.
PubMed 31570648Brown TE. ADD/ADHD and Impaired Executive Function in Clinical Practice. Curr Psychiatry Rep. 2008 Oct;10(5):407-11. doi: 10.1007/s11920-008-0065-7.
PubMed 18803914Brown TE, Holdnack J, Saylor K, Adler L, Spencer T, Williams DW, Padival AK, Schuh K, Trzepacz PT, Kelsey D. Effect of atomoxetine on executive function impairments in adults with ADHD. J Atten Disord. 2011 Feb;15(2):130-8. doi: 10.1177/1087054709356165. Epub 2009 Dec 21.
PubMed 20026871Qian Y, Chen M, Shuai L, Cao QJ, Yang L, Wang YF. Effect of an Ecological Executive Skill Training Program for School-aged Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Clinical Trial. Chin Med J (Engl). 2017 Jul 5;130(13):1513-1520. doi: 10.4103/0366-6999.208236.
PubMed 28639564Diamond A, Lee K. Interventions shown to aid executive function development in children 4 to 12 years old. Science. 2011 Aug 19;333(6045):959-64. doi: 10.1126/science.1204529.
PubMed 21852486Liang X, Li R, Wong SHS, Sum RKW, Sit CHP. The impact of exercise interventions concerning executive functions of children and adolescents with attention-deficit/hyperactive disorder: a systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2021 May 22;18(1):68. doi: 10.1186/s12966-021-01135-6.
PubMed 34022908
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Promotion of Systematic Aerobic Exercise and Intelligent Monitoring System in Executive Skill Training for School-aged Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT05668195
- Acronym / sponsor ID
- AEIMS
- Conditions
- ADHD
- Keywords
- ADHD, Executive Skill Training, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chen LiUniversity, hospital or other
- Collaborators
- Southwest University, China
- Study start
- 24 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Dec 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.
Around 7.2% of children around the world are suffering from Attention Deficit Hyperactivity Disorder (ADHD). Systematic executive skill training for children is currently recognized as one of the main programs for psychosocial behavioral interventions in ADHD, but the theoretical basis for the 1 hour "play class" component of the 3 hours per week children's classroom is insufficient. We have developed a closed-loop moderate-intensity aerobic training system, which is combined with an intelligent monitoring system, to further standardize and improve the treatment and management of ADHD intervention. The intelligent monitoring system in this study includes physiological intelligent monitoring (heart rate data) and psychological and behavioral intelligent monitoring (based on the computerized "adaptive" executive function testing procedures and clinical questionnaire scale). 200 subjects aged 6-12 years with a diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria are randomly assigned into two groups to receive executive skill training and systematic aerobic exercise and intelligent monitoring system, or systematic executive skill training for 13 weeks. Symptoms severity is assessed by Vanderbilt Assessment Scales at weeks 0, 6, and 13. Subjects' executive function is assessed using executive function tests before and after training, parental depression/anxiety assessment, family environment assessment, and monitoring of heart rate during exercise are also included. All the other sociodemographic data are assessed. This study will investigate the effects of systematic aerobic exercise and intelligent monitoring system in executive skill training on the promotion of cold executive functions such as responsiveness, flexibility, and inhibition and hot executive functions such as reward mechanisms in children, and their effects on children with ADHD and their families.
Detailed description
- Procedures. The children in the group are randomly divided into a test group and a control group, and further divided into 4 groups according to whether they were also treated with medication (methylphenidate) or not. Children receiving methylphenidate are required to be titrated to a stable dose before training, and those who did not change medication, stop medication, or adjust dose during training are included in the analysis. The children will be trained for 13 weeks, and the children with ADHD will be evaluated for symptoms and functions, parenting stress, and family environment at training weeks 0, 6, and 13, respectively; the children will be tested for executive function at training weeks 0 and 13; and the children with ADHD will be monitored for basic vital indicators.
- Demographic questionnaire and clinical data. The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, blood pressure, heart rate. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis, disease classification, current treatment, and comorbid conditions.
- Sample size. This study is a randomized controlled trial. Intervention group receives executive skill training and systematic aerobic exercise and intelligent monitoring system, control group receives systematic executive skill training. The primary outcome index is changes in ADHD symptoms evaluated by Vanderbilt Assessment Scales and changes in executive functions evaluated by executive function tests such as Stop-Signal task, GO/NO-GO task reflecting response control, Simon task reflecting conflict control, Dimensional Change Card Sorting (DCCS) task reflecting cognitive flexibility, and N-Back task reflecting working memory. Self-rating depression scale, self-rating anxiety scale are used to assess parental emotions, family environment scale-Chinese version is used to assess family environment. The child wears a heart rate band to monitor heart rate changes during exercise and the data is collected and analyzed in the background. Since this study is pioneering, the investigators artificially set the sample size at 200.
- Statistical analysis. All the data are analyzed using SPSS 25.0. The normality of variables are assessed by Kolmogorov Smirnov test. Comparison of parametric and nonparametric variables between groups are examined by F test and Kruskal-Wallis test, respectively. Paired t-test and Wilcoxon signed-rank test are used to investigate within-group differences. Confounding factors are adjusted by the analysis of covariance.
- Ethical matters and data protection. The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The children in the group are randomly divided into a test group and a control group, and further divided into 4 groups according to whether they were also treated with medication (methylphenidate) or not. Children receiving methylphenidate are required to be titrated to a stable dose before training, and those who did not change medication, stop medication, or adjust dose during training are included in the analysis. The test group receive systematic aerobic exercise and intelligent monitoring system in executive skill training, the control group receive systematic executive skill training, for 13 weeks. The research team, together with other teams, has initially developed a set of closed-loop training and is further exploring it in training.
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise group | Experimental | Procedure: systematic aerobic exercise and intelligent monitoring system in executive skill training, Procedure: executive skill trainingThe patients aged 6-12 with a diagnose of ADHD of this group receive systematic aerobic exercise and intelligent monitoring system in executive skill training for 13 weeks, including those taking methylphenidate or not. |
| executive skill training group | Active comparator | Procedure: executive skill trainingThe patients aged 6-12 with a diagnose of ADHD of this group receive executive skill training for 13 weeks, including those taking methylphenidate or not. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnose of ADHD according to DSM-5
- Aged 6-12 years
- Children receiving methylphenidate are required to be titrated to a stable dose before training, and those who did not change medication, stop medication, or adjust dose during training are included in the analysis
Key exclusion criteria (5 listed)
- IQ≤80
- Inconsistent or changing dose of methylphenidate during the participation period
- Suffering from organic lesions of nervous system now or in the past
- Suffering from epilepsy, autism spectrum disorder and other severe neurodevelopmental behavioral disorders now or in the past
- Not suitable for medium to high intensity aerobic training
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 |
|---|---|---|
| systematic aerobic exercise and intelligent monitoring system in executive skill trainingThis is a closed-loop training initially developed by the research team in conjunction with other teams, adding a systematic aerobic exercise and intelligent monitoring system to the typical executive skill training, and is being further explored in training. | Procedure or surgery | aerobic exercise group |
| executive skill trainingThe training program, based on Dawson and Guare's (2010) training of executive skills for children, aimed to improve the everyday performance of executive skills among children with ADHD. Qian Y and her team added some culturally adapted information, following the theory of cognitive behavioral therapy, to ensure that the concepts were acceptable to Chinese children. | Procedure or surgery | aerobic exercise group, executive skill training group |
Primary outcome
The changes in ADHD clinical symptoms-Estimated by Chinese version of Vanderbilt parent/teacher diagnostic scale
Time frame: at weeks 0 for the children with first diagnosis of ADHD
The Vanderbilt parent/teacher diagnostic scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56/36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard: Must score a 2 or 3 on 6 out of 9 items on questions 1-9(Predominantly Inattentive subtype)/10-18(Predominantly Hyperactive/Impulsive subtype)/both 1-9 and 10-18(ADHD Combined Inattention/Hyperactivity) AND Score a 4 or 5 on any of the Performance questions 49-56(parent)/36-43(teacher). The higher scores mean a worse outcome.
The changes in ADHD clinical symptoms-Estimated by Chinese version of Vanderbilt parent/teacher follow-up scale
Time frame: at weeks 0, 6 and 13
The Vanderbilt parent/teacher follow-up scale is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.
False alarms of GO/NO-GO task
Time frame: at weeks 0 and 13
GO/NO-GO task reflects response inhibition. Subjects are required to press a button when a certain stimulus appeared on the screen (e.g., a circle) and not when some other stimulus appeared (e.g., a triangle), with the majority of stimuli requiring a button (≥75%) and a small percentage of stimuli not requiring a button (≤25%). The false alarms are the numbers of stimuli to which subjects responded incorrectly that did not require a response.
The correct rate of GO/NO-GO task
Time frame: at weeks 0 and 13
GO/NO-GO task reflects response inhibition. Subjects are required to press a button when a certain stimulus appeared on the screen (e.g., a circle) and not when some other stimulus appeared (e.g., a triangle), with the majority of stimuli requiring a button (≥75%) and a small percentage of stimuli not requiring a button (≤25%). We will calculate the correct rate.
The correct rate of Stop-signal task
Time frame: at weeks 0 and 13
Similar to GO/NO-GO task, Stop-signal task also reflects response inhibition. The "GO" signal presents every time, but in a few instances the "GO" signal is followed by a "Stop" signal, when the subject was asked not to press the button. The majority of stimuli (≥75%) require to press a button, while the "GO" signal followed by a "Stop" signal is ≤25%. We will calculate the correct rate.
The correct rate of Simon task
Time frame: at weeks 0 and 13
Simon task reflects interference control. When subjects see stimulus A, press the left button (L); when they see stimulus B, press the right button (R). Stimuli A and B may appear in different directions. We will calculate the correct rate.
The number of correct switches of DCCS task
Time frame: at weeks 0 and 13
DCCS task reflects cognitive flexibility. Subjects are presented with a set of stimulus pictures with different dimensions (such as shape, number and color) and test pictures that can be matched with different stimulus pictures in different dimensions. Subjects need to classify the current stimulus according to different rules. When the rules change, they need to adjust their reactions as soon as possible and change the classification way. The number of correct switches refers to the number of times the subject continuously makes the correct response when the classification rule is changed.
The correct rate of DCCS task
Time frame: at weeks 0 and 13
DCCS task reflects cognitive flexibility. Subjects are presented with a set of stimulus pictures with different dimensions (such as shape, number and color) and test pictures that can be matched with different stimulus pictures in different dimensions. Subjects need to classify the current stimulus according to different rules. When the rules change, they need to adjust their reactions as soon as possible and change the classification way. We will calculate the correct rate.
The hit rate and the false alarm rate of N-back task
Time frame: at weeks 0 and 13
N-back task reflects working memory. The subjects are presented with a series of stimuli and asked to compare the current stimulus with the Nth stimulus backwards. If the two stimuli are the same, it is the target; if they are different, it is the non-target. The hit rate means that the subject responds correctly to the target, and the false alarm rate means that the subject responds incorrectly to the non-target.
4 secondary outcomes
The changes of parental mood-Estimated by Self-rating depression scale (SDS)
Time frame: at weeks 0, 6 and 13
The changes of parental mood-Estimated by Self-rating anxiety scale (SAS)
Time frame: at weeks 0, 6 and 13
The changes of family environment-Estimated by Family environment scale-Chinese version (FES-CV)
Time frame: at weeks 0, 6 and 13
The changes in heart rate
Time frame: during the class of aerobic exercise, about 40min per class, once a week, 13weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Background: PubMed 31570648Wolraich ML, Hagan JF Jr, Allan C, Chan E, Davison D, Earls M, Evans SW, Flinn SK, Froehlich T, Frost J, Holbrook JR, Lehmann CU, Lessin HR, Okechukwu K, Pierce KL, Winner JD, Zurhellen W; SUBCOMMITTEE ON CHILDREN AND ADOLESCENTS WITH ATTENTION-DEFICIT/HYPERACTIVE DISORDER. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019 Oct;144(4):e20192528. doi: 10.1542/peds.2019-2528.
- Background: PubMed 18803914Brown TE. ADD/ADHD and Impaired Executive Function in Clinical Practice. Curr Psychiatry Rep. 2008 Oct;10(5):407-11. doi: 10.1007/s11920-008-0065-7.
- Background: PubMed 20026871Brown TE, Holdnack J, Saylor K, Adler L, Spencer T, Williams DW, Padival AK, Schuh K, Trzepacz PT, Kelsey D. Effect of atomoxetine on executive function impairments in adults with ADHD. J Atten Disord. 2011 Feb;15(2):130-8. doi: 10.1177/1087054709356165. Epub 2009 Dec 21.
- Background: PubMed 28639564Qian Y, Chen M, Shuai L, Cao QJ, Yang L, Wang YF. Effect of an Ecological Executive Skill Training Program for School-aged Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Clinical Trial. Chin Med J (Engl). 2017 Jul 5;130(13):1513-1520. doi: 10.4103/0366-6999.208236.
- Background: PubMed 21852486Diamond A, Lee K. Interventions shown to aid executive function development in children 4 to 12 years old. Science. 2011 Aug 19;333(6045):959-64. doi: 10.1126/science.1204529.
- Background: PubMed 34022908Liang X, Li R, Wong SHS, Sum RKW, Sit CHP. The impact of exercise interventions concerning executive functions of children and adolescents with attention-deficit/hyperactive disorder: a systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2021 May 22;18(1):68. doi: 10.1186/s12966-021-01135-6.
- Individual participant dataSharing planned: No. Data is confidential during the study.
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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.
Li Chen, doctor study director
Children's Hospital of Chongqing Medical University
yu T Li, MS study chair
Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systematic aerobic exercise and intelligent monitoring system in executive skill training and executive skill training in people with ADHD, run by Chen Li at 1 site in China.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Feb 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Chen, doctor (136 7762 0103 ext. +86, chenli2012@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in ADHD clinical symptoms-Estimated by Chinese version of Vanderbilt parent/teacher diagnostic scale (time frame: at weeks 0 for the children with first diagnosis of ADHD). The study lists 9 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 NCT05668195, which also lists 6 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 10 Feb 2023.