Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT04112758
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2019-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Intervention on Conflict Monitoring in Children With Attention-deficit Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-14', 'studyFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2019-09-30', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Brain activation', 'timeFrame': 'Day 0 and post-intervention at Week 5', 'description': '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).'}], 'primaryOutcomes': [{'measure': 'Behavioral performance', 'timeFrame': 'Day 0 and post-intervention at Week 5', 'description': 'reaction time (ms) is generated by computerized task defined as correct responses within the range from 200-1500 ms'}, {'measure': 'Behavioral performance', 'timeFrame': 'Day 0 and post-intervention at Week 5', 'description': 'response accuracy (percentage) is generated by computerized task defined as percentage of trials that successfully responded to target stimulus'}], 'secondaryOutcomes': [{'measure': 'N2 & P3 components', 'timeFrame': 'Day 0 and post-intervention at Week 5', 'description': '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.\n\nThe 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIIT', 'executive function', 'ADHD', 'chronic exercise'], 'conditions': ['Exercise Intervention']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The present study will have two experiments, one is a cross-section study and the other is intervention study.\n\nAs for cross-section study, typical developmental children and children with ADHD will perform the stroop task while recording their brain waves.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age between 7 and 12 years\n2. diagnosed with ADHD by a pediatric psychiatrist, which is not required for TD\n3. no history of brain injury or neurological conditions, such as exhibited epileptic seizures, serious head injuries, and periods of unconsciousness.\n\nExclusion Criteria:\n\n1. cannot follow the instruction\n2. cannot complete all the procedure'}, 'identificationModule': {'nctId': 'NCT04112758', 'acronym': 'ADHD', 'briefTitle': 'Exercise Intervention on Conflict Monitoring in Children With Attention-deficit Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan Normal University'}, 'officialTitle': 'The Effect of Long-term High-intensity Interval Training on Conflict Monitoring in Children With ADHD: an ERP and sLORETA Study', 'orgStudyIdInfo': {'id': '201903HM013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'The group will receive twice a week for 5 week', 'interventionNames': ['Other: High-intensity interval training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The group will be maintained their normal after school activities'}], 'interventions': [{'name': 'High-intensity interval training', 'type': 'OTHER', 'description': '2 times weekly for 5 weeks Circuit training with 4 stations', 'armGroupLabels': ['Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan Normal University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral student', 'investigatorFullName': 'Yu-Jung Tsai', 'investigatorAffiliation': 'National Taiwan Normal University'}}}}