ADHDNCT04279652
Exercise in Children Attention Deficit Hyperactivity Disorder
A study testing Combined exercise in people with ADHD and Exercise, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) is a heterogeneous neurodevelopmental disorder characterized by carelessness, hyperactivity and impulsivity, in which genetic, social and physical factors play an important role. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Combined exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2019to 10 Nov 2022
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having been diagnosed with ADHD according to DSM-V (The Diagnostic and Statistical Manual of Mental Disorders-V) diagnostic criteria,
- Being between the ages of 7-12,
- Right hand being dominant according to Edinburgh Hand Preference Questionnaire,
- After the purpose of the study and the procedures to be explained, both the child and his family agree to participate in the study,
- An appropriate drug treatment program has been organized by the psychiatrist,
- The absence of a contraindicated condition to exercise in physical and medical examination.
Who cannot join
- A major psychiatric and / or neurodevelopmental problem accompanying,
- A history of head injury or chronic neurological disease,
- Having additional medical diseases that require medication,
- Any changes made in the psychiatric drug treatment by the attending physician for the last 1 month,
- Have participated in a regular exercise program or sporting activity for the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Combined Exercise Program in Children Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder (ADHD) is a heterogeneous neurodevelopmental disorder characterized by carelessness, hyperactivity and impulsivity, in which genetic, social and physical factors play an important role. Few studies have revealed the physical activity levels and importance of children with ADHD, but there is no consensus on the components of the physical activity program such as intensity, frequency, and severity. The aim of the present study is to investigate the effect of combined exercise training on motor proficiency, physical fitness and cognitive status in children with ADHD.
Read the detailed description
The aim of present study is to investigate the effect of combined exercise training on motor proficiency, physical fitness and cognitive status in children with ADHD. Children will be randomly divided into 3 groups, for 8 weeks the first group will undergo a combined exercise training under the supervision of a physiotherapist, while the second group will receive a home exercise program. children included in the third group will form the control group.
The following assessments will be applied at the beginning and end of treatment.
- Revised Conners Parent Rating Scale Short Turkish Form
- Powers and Challenges Survey
- Edinburgh Hand Preference Survey
- Two-minute walking test
- Ten meter walking test
- Munich Fitness Test
- Bruininks-Oseretsky Motor Proficiency Test-2
- Muscle strength evaluation
- Dynamic Occupational Therapy Cognitive Assessment
- Open-ended questions
- Being tested
- Combined exercise
- Keywords
- ADHD, Exercise, motor proficiency
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exerciseOther
Combined exercise program consists of 5 min warm-up exercises, 20 min aerobic exercise, 20 min balance-coordination exercises, 10 min strengthening exercises and 5 min cooling exercises.
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise group | Experimental | The treatment program was determined as 3 sessions per week for 8 weeks and 60 minutes per session. The treatment program consists of 5 min warm-up exercises, 20 min aerobic exercise, 20 min balance-coordination exercises, 10 min strengthening exercises and 5 min cooling exercises. Receives: Other: Combined exercise |
| Home exercise group | Active comparator | The exercise program, which is prepared for the individual, will be applied to the home exercise group with 60 minutes of 3 times a week. Receives: Other: Combined exercise |
| Control group | No intervention | Children will not be included in any treatment program. The assessments will be done again 8 weeks later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Proficiency
Motor proficiency will be evaluated The Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT™-2). t contains subtests and challenging game-like tasks and is very easy to administer. the score of this test ranges from 0 to 322. Higher score indicates better motor proficiency
Measured: 45 minutes
Cognitive assessment
Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch) battery for children allows to evaluate cognitive skills in 5 main topics: orientation, spatial perception, praxis, visual-motor organization and thinking processes.
Measured: 90 minutes
Physical Fitness
Munich Fitness Test
Measured: 15 minutes
Secondary outcomes (7)
Behavior Disorders
Conners Parent Rating Scale consists of 27 items in total. In this scale, questions are answered on a 4-point Likert scale. "Never", "rarely", "often" and "always" options are; It is scored as "0", "1", "2" and "3". High scores from the scale show the intensity of symptoms specific to destructive disorders
Measured: 5 minutes
Behaviour characteristics
Strength and Difficulties Questionnaire - (SDQ) "contains 25 questions, some of which question positive and some negative behavior characteristics. Each sub-title can be evaluated within itself and a separate score can be obtained for each, as well as the sum of the first four titles and the" Total Strength Score ".
Measured: 5 minutes
Hand dominance
Edinburgh Hand Preference Questionnaire was developed to determine the hand preferences of the persons.The sum of the right and left hand scores gives "Cumulative Total (TC)" and subtracting the left hand score from the right hand score gives "Difference score (F)". The result score is obtained by dividing the difference score by the cumulative total score and multiplying it by the face. Result score; It can be interpreted that if the person is less than 40, the person is left dominant, and between -40 and 40, each bilateral dominant, and if greater than 40, the person is right dominant.
Measured: 5 minutes
gait endurance
2-minute walking test will be used to determine walking endurance. In this test, a distance of 50 feet (15.2 meters) in length is determined first. The evaluator marks each 10 foot long distance with markers, leaving a cone at the beginning and end of the total distance.
Measured: 4 minutes
muscle strength
Isometric muscle strength will be evaluated by hand dynamometer. Care is taken to repeat 3 times at short intervals during measurements. The highest value will be used for analysis. 4 muscle groups, including shoulder abductors, grip strength, hip flexors and ankle dorsi flexors, will be evaluated bilaterally.
Measured: 10 minutes
10 meter walking test
Walking speed
Measured: 2 minutes
Open ended questions
these questions for social cooperation and behaviour
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start10 Oct 2019
- Primary completion10 Aug 2022
- Study completion10 Nov 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Demircioğlu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279652
- Sponsor's protocol ID
- KA-19032
- Status last verified
- Dec 2025
- First submitted
- 19 Feb 2020
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Exercise Program in Children Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT04279652
- Acronym / sponsor ID
- KA-19032
- Keywords
- ADHD, Exercise, motor proficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 21 Feb 2020 (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.
Attention Deficit Hyperactivity Disorder (ADHD) is a heterogeneous neurodevelopmental disorder characterized by carelessness, hyperactivity and impulsivity, in which genetic, social and physical factors play an important role. Few studies have revealed the physical activity levels and importance of children with ADHD, but there is no consensus on the components of the physical activity program such as intensity, frequency, and severity. The aim of the present study is to investigate the effect of combined exercise training on motor proficiency, physical fitness and cognitive status in children with ADHD.
Detailed description
The aim of present study is to investigate the effect of combined exercise training on motor proficiency, physical fitness and cognitive status in children with ADHD. Children will be randomly divided into 3 groups, for 8 weeks the first group will undergo a combined exercise training under the supervision of a physiotherapist, while the second group will receive a home exercise program. children included in the third group will form the control group.
The following assessments will be applied at the beginning and end of treatment.
- Revised Conners Parent Rating Scale Short Turkish Form
- Powers and Challenges Survey
- Edinburgh Hand Preference Survey
- Two-minute walking test
- Ten meter walking test
- Munich Fitness Test
- Bruininks-Oseretsky Motor Proficiency Test-2
- Muscle strength evaluation
- Dynamic Occupational Therapy Cognitive Assessment
- Open-ended questions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise group | Experimental | Other: Combined exerciseThe treatment program was determined as 3 sessions per week for 8 weeks and 60 minutes per session. The treatment program consists of 5 min warm-up exercises, 20 min aerobic exercise, 20 min balance-coordination exercises, 10 min strengthening exercises and 5 min cooling exercises. |
| Home exercise group | Active comparator | Other: Combined exerciseThe exercise program, which is prepared for the individual, will be applied to the home exercise group with 60 minutes of 3 times a week. |
| Control group | No intervention | –Children will not be included in any treatment program. The assessments will be done again 8 weeks later. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Having been diagnosed with ADHD according to DSM-V (The Diagnostic and Statistical Manual of Mental Disorders-V) diagnostic criteria,
- Being between the ages of 7-12,
- Right hand being dominant according to Edinburgh Hand Preference Questionnaire,
- After the purpose of the study and the procedures to be explained, both the child and his family agree to participate in the study,
- An appropriate drug treatment program has been organized by the psychiatrist,
Key exclusion criteria (5 listed)
- A major psychiatric and / or neurodevelopmental problem accompanying,
- A history of head injury or chronic neurological disease,
- Having additional medical diseases that require medication,
- Any changes made in the psychiatric drug treatment by the attending physician for the last 1 month,
- Have participated in a regular exercise program or sporting activity for the past 6 months.
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 |
|---|---|---|
| Combined exerciseCombined exercise program consists of 5 min warm-up exercises, 20 min aerobic exercise, 20 min balance-coordination exercises, 10 min strengthening exercises and 5 min cooling exercises. | Other | Home exercise group, Supervised exercise group |
Primary outcome
Motor Proficiency
Time frame: 45 minutes
Motor proficiency will be evaluated The Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT™-2). t contains subtests and challenging game-like tasks and is very easy to administer. the score of this test ranges from 0 to 322. Higher score indicates better motor proficiency
Cognitive assessment
Time frame: 90 minutes
Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch) battery for children allows to evaluate cognitive skills in 5 main topics: orientation, spatial perception, praxis, visual-motor organization and thinking processes.
Physical Fitness
Time frame: 15 minutes
Munich Fitness Test
7 secondary outcomes
Behavior Disorders
Time frame: 5 minutes
Behaviour characteristics
Time frame: 5 minutes
Hand dominance
Time frame: 5 minutes
gait endurance
Time frame: 4 minutes
muscle strength
Time frame: 10 minutes
10 meter walking test
Time frame: 2 minutes
Open ended questions
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise in people with ADHD and Exercise, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 29 Dec 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Proficiency (time frame: 45 minutes). The study lists 3 primary outcomes in all. 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 29 Dec 2025.