Effects of an Aerobic Exercise Intervention on Core Symptoms, Executive Functioning, and Quality of Life in Children With Attention Deficit Hyperactivity Disorder

August 11, 2024 updated by: Lingrong Xiao, Harbin Medical University
Selecting a maternal and child healthcare hospital in Shenzhen City, Guangdong Province, 50 cases of ADHD children as the study subjects, according to the inclusion and exclusion criteria to screen the eligible study subjects, introduction of the purpose and process of the study, informed consent to enrolment, the children were divided into the intervention group and the control group. The experimental group used aerobic exercise, while the control group was given daily physical activity, and general information questionnaires, Conners Parental Symptom Questionnaire, SNAP-IV scale, Stroop Colour Word Test, Rey Complex Graphics Test, Connection Test, Children's Depressive Disorder Self-assessment Scale, Children's Anxious Mood Disorder Screening Scale, Children's Quality of Life Universal Core Scale, and Children's Executive Functioning Questionnaire were assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purposive sampling method was used to select a maternal and child healthcare hospital in Shenzhen City, Guangdong Province, 50 cases of ADHD children as the study subjects, according to the inclusion and exclusion criteria to screen the eligible study subjects, introduction of the purpose and process of the study, informed consent to enrolment, the children were divided into age, gender, clinical typing, medication use, family proximity, Conners scores and SNAP-IV scores matching the intervention group and the control group. The experimental group used aerobic exercise, while the control group was given daily physical activity, and general information questionnaires, Conners Parental Symptom Questionnaire, SNAP-IV scale, Stroop Colour Word Test, Rey Complex Graphics Test, Connection Test, Children's Depressive Disorder Self-assessment Scale, Children's Anxious Mood Disorder Screening Scale, Children's Quality of Life Universal Core Scale, and Children's Executive Functioning Questionnaire were assessed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shenzhen
      • Guangzhou, Shenzhen, China
        • Recruiting
        • Nanshan Maternal and Child Health Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children clinically diagnosed with ADHD;
  • 7-14 years old;
  • Combined Raven's Test ≥ 80;
  • Not participating in any treatment other than drug therapy;
  • The body can participate in sports training;
  • The type of family intimacy is intimate or above;
  • Voluntarily participate and sign an informed consent form

Exclusion Criteria:

  • Children with a history of epileptic seizures;
  • Children with other mental or motor disorders;
  • Children with visual impairments;
  • Using other psychotropic drugs;
  • Have other comorbidities;
  • Merge other serious chronic diseases (such as severe heart, brain, kidney, lung, etc.), tumors, etc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Moderate-intensity aerobic exercise for 30-60 min 3 times per week for 12 weeks and daily physical activity
Behavioral: aerobics exercises
Moderate-intensity aerobic exercise for 30-60 min 3 times per week for 12 weeks
No Intervention: Control group
daily physical activity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ADHD core symptoms
Time Frame: Immediately after the intervention
The Conners Parental Symptom Questionnaire for core symptoms. There are a total of 48 items, including six factors. They are scored on a scale of 0-3, with 0 indicating no problem; 1, occasionally or slightly; 2, frequent or severe; 3, always or very serious. The factor score is the average score of the items within the factor, and the higher the score, the more severe the symptom. The SNAP-IV for ADHD children's inattention and hyperactivity/impulsivity. This scale consists of 26 items and consists of three subscales. Each item is rated on a four point scale from 0 to 3: 0, "never or rarely"; 1, "sometimes"; 2, "often"; 3, 'very common'. The average score of each subscale is the ratio of the total score of the obtained items to the number of items included. Scores from 0-1 are considered normal, 1.1-1.5 are critical, 1.6-2 are moderate, and>2 are severe. The higher the total score and subscale score, the more severe the damage to the core symptoms of ADHD.
Immediately after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
executive function
Time Frame: Immediately after the intervention
Stroop color-word test for Inhibitory control, Rey-Osterrieth Complex Figure for working memory, Trail Making Test for cognitive flexibility and Questionnaire of Executive Functioning Scale for total executive function. The Questionnaire of Executive Functioning Scale consists of 36 items and 8 factors including attention concentration, working memory, self-regulation, theory of mind, flexible switching, impulse suppression, plan initiation, and emotion regulation. All items are rated on a 4-point scale from 1 (never) to 4 (always). The higher the score, the worse the performance of the execution function.
Immediately after the intervention
quality of life
Time Frame: Immediately after the intervention
The Pediatric Quality of Life Inventory Version 4.0 Generic CoreScales to measure ADHD children's quality of life. The scale has 23 items, including four dimensions: physiological function, emotional function, social function, and role function. Each item is scored on a Likert 5-point scale, and the total score of the scale is equal to the sum of the scores of each item. The higher the score, the better the quality of life.
Immediately after the intervention
mental health
Time Frame: Immediately after the intervention
Depression Self-Rating Scale for Children to measure depression. There are a total of 18 items, rated on a 0-2 scale, with 0 indicating no symptoms, 1 indicating occasional symptoms, and 2 indicating frequent symptoms. The sum of each item is the total score, with higher scores indicating more severe depression, and a total score greater than 14 indicating possible depression. Screen for Child Anxiety Related Emotional Disorders to measure anxiety. There are a total of 41 items consisting of 5 factors, namely somatic symptoms/panic, generalized anxiety, dissociative anxiety, social phobia, and school phobia. Each item is rated on a scale of 0-2, where 0 indicates no such symptoms, 1 indicates partial presence, and 2 indicates frequent presence. The higher the score, the more severe the anxiety level. A total score of more than 23 on the scale may indicate a significant state of anxiety
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LXiao

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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