ADHDNCT06553430
Effects of an Aerobic Exercise Intervention on Core Symptoms, Executive Functioning, and Quality of Life in Children With Attention Deficit Hyperactivity Disorder
A study testing aerobics exercises in people with ADHD, run by Harbin Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- ADHD
- What is being tested?
- aerobics exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2023to Nov 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanshan Maternal and Child Health Hospital
Guangzhou, Shenzhen
Gang Zhao, 17382797561, zgang230@126.com
About this study
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- aerobics exercises
- 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.
aerobics exercisesBehavioural
Moderate-intensity aerobic exercise for 30-60 min 3 times per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Moderate-intensity aerobic exercise for 30-60 min 3 times per week for 12 weeks and daily physical activity Receives: Behavioral: aerobics exercises |
| Control group | No intervention | daily physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start28 Nov 2023
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingrong Xiao, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553430
- Sponsor's protocol ID
- LXiao
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Aerobic Exercise Intervention on Core Symptoms, Executive Functioning, and Quality of Life in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT06553430
- Acronym / sponsor ID
- LXiao
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 14 Aug 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: aerobics exercisesModerate-intensity aerobic exercise for 30-60 min 3 times per week for 12 weeks and daily physical activity |
| Control group | No intervention | –daily physical activity |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| aerobics exercisesModerate-intensity aerobic exercise for 30-60 min 3 times per week for 12 weeks | Behavioural | Intervention group |
Primary outcome
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.
3 secondary outcomes
executive function
Time frame: Immediately after the intervention
quality of life
Time frame: Immediately after the intervention
mental health
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobics exercises in people with ADHD, run by Harbin Medical University 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 7 inclusion and 6 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 14 Aug 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD core symptoms (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2024.