Systematic Aerobics and Intelligent Monitoring System in Executive Skill Training for School-aged Children With ADHD

NCT ID: NCT05668195

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-24
• Study Completion Date: 2024-12-31

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

aerobic exercise group

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.

Group Type: EXPERIMENTAL

systematic aerobic exercise and intelligent monitoring system in executive skill training

Intervention Type: PROCEDURE

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 training

Intervention Type: PROCEDURE

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.

executive skill training group

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.

Group Type: ACTIVE_COMPARATOR

executive skill training

Intervention Type: PROCEDURE

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.

Interventions

systematic aerobic exercise and intelligent monitoring system in executive skill training

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.

Intervention Type: PROCEDURE

executive skill training

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest University, China

UNKNOWN

Sponsor Role: collaborator

Chen Li

OTHER

Sponsor Role: lead

Responsible Party

Chen Li

Associate Professor, Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Li Chen, doctor

Role: STUDY_DIRECTOR

Children's Hospital of Chongqing Medical University

yu T Li, MS

Role: STUDY_CHAIR

Children's Hospital of Chongqing Medical University

Locations

Growth, Development and Mental health of Children and Adolescence Center

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Chen, doctor

Role: CONTACT

chenli2012@126.com

136 7762 0103 ext. +86

Facility Contacts

Li Chen, MD

Role: primary

chenli2012@126.com

(+86)136 7762 0103 ext. +86

References

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Reference Type: BACKGROUND

PMID: 31570648 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18803914 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 21852486 (View on PubMed)

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Reference Type: BACKGROUND

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Other Identifiers

AEIMS

Identifier Type: -

Identifier Source: org_study_id