Clinical trial NCT05668195: Systematic Aerobics and Intelligent Monitoring System in Executive Skill Training for School-aged Children With ADHD
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Keywords: ADHD, Executive Skill Training, Aerobic Exercise
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Southwest University, China
First posted: 2022-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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" 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: 1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The changes in ADHD clinical symptoms-Estimated by Chinese version of Vanderbilt parent/teacher diagnostic scale
timeFrame: at weeks 0 for the children with first diagnosis of ADHD
measure: The changes in ADHD clinical symptoms-Estimated by Chinese version of Vanderbilt parent/teacher follow-up scale
timeFrame: at weeks 0, 6 and 13
measure: False alarms of GO/NO-GO task
timeFrame: at weeks 0 and 13
measure: The correct rate of GO/NO-GO task
timeFrame: at weeks 0 and 13
measure: The correct rate of Stop-signal task
timeFrame: at weeks 0 and 13
measure: The correct rate of Simon task
timeFrame: at weeks 0 and 13
measure: The number of correct switches of DCCS task
timeFrame: at weeks 0 and 13
measure: The correct rate of DCCS task
timeFrame: at weeks 0 and 13
measure: The hit rate and the false alarm rate of N-back task
timeFrame: at weeks 0 and 13
Secondary outcomes:
measure: The changes of parental mood-Estimated by Self-rating depression scale (SDS)
timeFrame: at weeks 0, 6 and 13
measure: The changes of parental mood-Estimated by Self-rating anxiety scale (SAS)
timeFrame: at weeks 0, 6 and 13
measure: The changes of family environment-Estimated by Family environment scale-Chinese version (FES-CV)
timeFrame: at weeks 0, 6 and 13
measure: The changes in heart rate
timeFrame: during the class of aerobic exercise, about 40min per class, once a week, 13weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Growth, Development and Mental health of Children and Adolescence Center
state: Chongqing
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Li Chen, doctor
role: STUDY_DIRECTOR
affiliation: Children's Hospital of Chongqing Medical University
name: yu T Li, MS
role: STUDY_CHAIR
References:
citation: 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.
citation: Brown 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.
citation: Brown 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.
citation: Qian 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.
citation: Diamond 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.
citation: Liang 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.