Exercise Intervention on Conflict Monitoring in Children With Attention-deficit Hyperactivity Disorder (ADHD)

January 14, 2023 updated by: Yu-Jung Tsai, National Taiwan Normal University

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan
        • National Taiwan Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age between 7 and 12 years
  2. diagnosed with ADHD by a pediatric psychiatrist, which is not required for TD
  3. no history of brain injury or neurological conditions, such as exhibited epileptic seizures, serious head injuries, and periods of unconsciousness.

Exclusion Criteria:

  1. cannot follow the instruction
  2. cannot complete all the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

January 23, 2022

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 14, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 201903HM013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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