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

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: Recruiting
• Conditions: ADHD
• Intervention / Treatment: Behavioral: aerobics exercises

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: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shenzhen
    • Guangzhou, Shenzhen, China
      • Recruiting
      • Nanshan Maternal and Child Health Hospital
      • Contact: Gang Zhao; Phone Number: 17382797561; Email: zgang230@126.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
ADHD core symptoms	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

Outcome Measure	Measure Description	Time Frame
executive function	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	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	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

• Sponsor: Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID 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