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Completed

NCT Number: NCT04112758

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

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.

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Key information

Conditions

Exercise Intervention Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan Normal University

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity interval training

Other

2 times weekly for 5 weeks Circuit training with 4 stations

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

National Taiwan Normal University

Other

Registry information

Official study title

The Effect of Long-term High-intensity Interval Training on Conflict Monitoring in Children With ADHD: an ERP and sLORETA Study

Acronym: ADHD

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 2, 2019
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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