- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04112758
Exercise Intervention on Conflict Monitoring in Children With Attention-deficit Hyperactivity Disorder (ADHD)
The Effect of Long-term High-intensity Interval Training on Conflict Monitoring in Children With ADHD: an ERP and sLORETA Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan
- National Taiwan Normal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- cannot follow the instruction
- cannot complete all the procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise group
The group will receive twice a week for 5 week
|
2 times weekly for 5 weeks Circuit training with 4 stations
|
|
No Intervention: Control group
The group will be maintained their normal after school activities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Day 0 and post-intervention at Week 5
|
|
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
|
Day 0 and post-intervention at Week 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
N2 & P3 components
Time Frame: Day 0 and post-intervention at Week 5
|
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. |
Day 0 and post-intervention at Week 5
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain activation
Time Frame: Day 0 and post-intervention at Week 5
|
To examine sources relating to amplitude in ERPs, source localization will be conducted using standardized low resolution brain electromagnetic tomography (sLORETA) The sLORETA analysis with the ERP data will be selected by four 100 ms bins covering the period from 0 to 200 ms after stimulus-onset (0-50, 50-100, 100-150, and 150-200 ms).
|
Day 0 and post-intervention at Week 5
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 201903HM013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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