Exercise InterventionADHDNCT04112758
Exercise Intervention on Conflict Monitoring in Children With Attention-deficit Hyperactivity Disorder
A study testing High-intensity interval training in people with Exercise Intervention, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
The study mainly investigates the effect of high-intensity interval training on conflict monitoring in children with ADHD by using event-related potential and sLORETA techniques. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Intervention
- What is being tested?
- High-intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2020to 23 Jan 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
- age between 7 and 12 years
- diagnosed with ADHD by a pediatric psychiatrist, which is not required for TD
- no history of brain injury or neurological conditions, such as exhibited epileptic seizures, serious head injuries, and periods of unconsciousness.
Who cannot join
- cannot follow the instruction
- cannot complete all the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Long-term High-intensity Interval Training on Conflict Monitoring in Children With ADHD: an ERP and sLORETA Study
The study mainly investigates the effect of high-intensity interval training on conflict monitoring in children with ADHD by using event-related potential and sLORETA techniques.
Read the detailed description
The present study will have two experiments, one is a cross-section study and the other is intervention study.
As for cross-section study, typical developmental children and children with ADHD will perform the stroop task while recording their brain waves.
The intervention is twice a week for 5 weeks and before and after the intervention, children with ADHD will randomly assign to either an exercise group or control group. They will perform the stroop task while recording their brain waves.
- Conditions
- Exercise Intervention
- Being tested
- High-intensity interval training
- Keywords
- HIIT, executive function, ADHD, chronic exercise
- 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.
High-intensity interval trainingOther
2 times weekly for 5 weeks Circuit training with 4 stations
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The group will receive twice a week for 5 week Receives: Other: High-intensity interval training |
| Control group | No intervention | The group will be maintained their normal after school activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral performance
reaction time (ms) is generated by computerized task defined as correct responses within the range from 200-1500 ms
Measured: Day 0 and post-intervention at Week 5
Behavioral performance
response accuracy (percentage) is generated by computerized task defined as percentage of trials that successfully responded to target stimulus
Measured: Day 0 and post-intervention at Week 5
Secondary outcomes (1)
N2 & P3 components
Electroencephalographic (EEG) activity will be measured at 64 sites. The amplitude of the N2 is defined as the mean amplitude within a 50-ms interval surrounding the maximal negative peak within a 200- to 400-ms latency window.
The amplitude of the P3 is defined as the mean amplitude within a 50-ms interval surrounding the maximal positive peak within a 300- to 800-ms latency window.
Measured: Day 0 and post-intervention at Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Jun 2020
- Primary completion30 Apr 2021
- Study completion23 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise InterventionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Jung Tsai, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112758
- Sponsor's protocol ID
- 201903HM013
- Acronym
- ADHD
- Status last verified
- Jan 2023
- First submitted
- 27 Sep 2019
- Last updated
- 18 Jan 2023
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long-term High-intensity Interval Training on Conflict Monitoring in Children With ADHD: an ERP and sLORETA Study
- ClinicalTrials.gov ID
- NCT04112758
- Acronym / sponsor ID
- ADHD / 201903HM013
- Conditions
- Exercise Intervention
- Keywords
- HIIT, executive function, ADHD, chronic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 23 Jan 2022 (actual)
- First posted
- 2 Oct 2019 (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.
The study mainly investigates the effect of high-intensity interval training on conflict monitoring in children with ADHD by using event-related potential and sLORETA techniques.
Detailed description
The present study will have two experiments, one is a cross-section study and the other is intervention study.
As for cross-section study, typical developmental children and children with ADHD will perform the stroop task while recording their brain waves.
The intervention is twice a week for 5 weeks and before and after the intervention, children with ADHD will randomly assign to either an exercise group or control group. They will perform the stroop task while recording their brain waves.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: High-intensity interval trainingThe group will receive twice a week for 5 week |
| Control group | No intervention | –The group will be maintained their normal after school activities |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between 7 and 12 years
- diagnosed with ADHD by a pediatric psychiatrist, which is not required for TD
- no history of brain injury or neurological conditions, such as exhibited epileptic seizures, serious head injuries, and periods of unconsciousness.
Key exclusion criteria (2 listed)
- cannot follow the instruction
- cannot complete all the procedure
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 |
|---|---|---|
| High-intensity interval training2 times weekly for 5 weeks Circuit training with 4 stations | Other | Exercise group |
Primary outcome
Behavioral performance
Time frame: Day 0 and post-intervention at Week 5
reaction time (ms) is generated by computerized task defined as correct responses within the range from 200-1500 ms
Behavioral performance
Time frame: Day 0 and post-intervention at Week 5
response accuracy (percentage) is generated by computerized task defined as percentage of trials that successfully responded to target stimulus
1 secondary outcome
N2 & P3 components
Time frame: Day 0 and post-intervention at Week 5
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 18 Jan 2023.
- 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 High-intensity interval training in people with Exercise Intervention, run by National Taiwan Normal University at 1 site in Taiwan.
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 3 inclusion and 2 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 18 Jan 2023. 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 Taiwan. 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?
Behavioral performance (time frame: Day 0 and post-intervention at Week 5). The study lists 2 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 18 Jan 2023.