Attention Deficit Hyperactivity DisorderNCT03678844
Taekwondo Practice in Adolescents With Attention Deficit Hyperactivity Disorder
A study testing Taekwondo practice in people with Attention Deficit Hyperactivity Disorder, run by University of Genova.
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neuro-developmental/behavioral disorders among adolescents. Sport and physical activity seem to play a major role in the development of cognition, memory, selective attention and motor reaction time, especially among adolescents with ADHD. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Taekwondo practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 17 Jan 2017
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents with Attention Deficit Hyperactivity Disorder
Who cannot join
- Participants with good attentional performance
About this study
Official title: Effect of Taekwondo Practice on Cognitive Function in Adolescents With Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neuro-developmental/behavioral disorders among adolescents. Sport and physical activity seem to play a major role in the development of cognition, memory, selective attention and motor reaction time, especially among adolescents with ADHD. In this context, the objective of this study was to investigate the effects of a one and a half year long Taekwondo (TKD) intervention on cognitive function in adolescents with ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Taekwondo practice, CONTROL
- 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.
Taekwondo practiceBehavioural
The Taekwondo intervention program consisted of the technical skill development aspect (e.g., blocking, punching and kicking) of the sport and poomse (forms) for 30-min.
CONTROLOther
The participants of the control group engaged in physical activities, including athletics, handball and gymnastic, during two sessions of physical education per week at school.
| Study group | Role | What they receive |
|---|---|---|
| Taekwondo practice | Experimental | Not described Receives: Behavioral: Taekwondo practice; Other: CONTROL |
| CONTROL | Placebo comparator | Not described Receives: Behavioral: Taekwondo practice; Other: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop
Participants are presented with a page consisting of five columns, each with 20 items for a total of 100 items per page.
Measured: 45 seconds
Secondary outcomes (1)
Ruff 2 and 7
This test consists of a series of 20 blocks (10 blocks of digits only and 10 blocks of both digits and letters).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Sep 2015
- Primary completion1 Jan 2017
- Study completion17 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maamer Slimani, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678844
- Sponsor's protocol ID
- TKD0012
- Status last verified
- Oct 2018
- First submitted
- 18 Sep 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall data
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Taekwondo Practice on Cognitive Function in Adolescents With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03678844
- Acronym / sponsor ID
- TKD0012
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 20 Sep 2018 (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 one of the most common neuro-developmental/behavioral disorders among adolescents. Sport and physical activity seem to play a major role in the development of cognition, memory, selective attention and motor reaction time, especially among adolescents with ADHD. In this context, the objective of this study was to investigate the effects of a one and a half year long Taekwondo (TKD) intervention on cognitive function in adolescents with ADHD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taekwondo practice | Experimental | Behavioral: Taekwondo practice, Other: CONTROL |
| CONTROL | Placebo comparator | Behavioral: Taekwondo practice, Other: CONTROL |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents with Attention Deficit Hyperactivity Disorder
Key exclusion criteria (1 listed)
- Participants with good attentional performance
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 |
|---|---|---|
| Taekwondo practiceThe Taekwondo intervention program consisted of the technical skill development aspect (e.g., blocking, punching and kicking) of the sport and poomse (forms) for 30-min. | Behavioural | CONTROL, Taekwondo practice |
| CONTROLThe participants of the control group engaged in physical activities, including athletics, handball and gymnastic, during two sessions of physical education per week at school. | Other | CONTROL, Taekwondo practice |
Primary outcome
Stroop
Time frame: 45 seconds
Participants are presented with a page consisting of five columns, each with 20 items for a total of 100 items per page.
1 secondary outcome
Ruff 2 and 7
Time frame: 5 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 23 Oct 2018.
- Individual participant dataSharing planned: No. Overall data
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Taekwondo practice in people with Attention Deficit Hyperactivity Disorder, run by University of Genova.
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 1 inclusion and 1 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Stroop (time frame: 45 seconds). 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 23 Oct 2018.