NCT04112758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

September 27, 2019

Last Update Submit

January 14, 2023

Conditions

Exercise Intervention

Keywords

HIITexecutive functionADHDchronic exercise

Outcome Measures

Primary Outcomes (2)

  • Behavioral performance

    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

    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 Outcomes (1)

  • N2 & P3 components

    Day 0 and post-intervention at Week 5

Other Outcomes (1)

  • Brain activation

    Day 0 and post-intervention at Week 5

Study Arms (2)

Exercise group

EXPERIMENTAL

The group will receive twice a week for 5 week

Other: High-intensity interval training

Control group

NO INTERVENTION

The group will be maintained their normal after school activities

Interventions

High-intensity interval trainingOTHER

2 times weekly for 5 weeks Circuit training with 4 stations

Exercise group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • cannot follow the instruction
  • cannot complete all the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral student

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 2, 2019

Study Start

June 1, 2020

Primary Completion

April 30, 2021

Study Completion

January 23, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)