ADHD: Exercise Intervention on Inhibition in Children With Attention-deficit Hyperactivity Disorder

• Sponsor: National Taiwan Normal University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04112758
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.5
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

The study mainly investigates the effect of high-intensity interval training on inhibitory control in children with ADHD by using event-related potential and sLORETA techniques.

Condition or Disease	Intervention/Treatment	Phase
Exercise Intervention	Other: High-intensity interval training	N/A

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 inhibitory task with non-emotional and emotional stimulus 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 inhibitory task while recording their brain waves.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Effect of Long-term High-intensity Interval Training on Inhibitory Control in Children With ADHD: an ERP and sLORETA Study
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Aug 30, 2021
• Anticipated Study Completion Date: Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise group The group will receive twice a week for 5 week	Other: High-intensity interval training; 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

Outcome Measures

Primary Outcome Measures

1. Behavioral performance [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 [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 Outcome Measures

1. Error related negativity (ERN) [Day 0 and post-intervention at Week 5]

   Electroencephalographic (EEG) activity will be measured at 64 sites. The amplitude of the ERN is defined as the mean amplitude within a 100-ms interval surrounding the maximal positive peak within a 50- to 100-ms latency window.

Other Outcome Measures

1. Brain activation [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan Normal University	Taipei		Taiwan

Sponsors and Collaborators

• National Taiwan Normal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yu-Jung Tsai, Doctoral student, National Taiwan Normal University
• ClinicalTrials.gov Identifier: NCT04112758
• Other Study ID Numbers: 201903HM013
• First Posted: Oct 2, 2019
• Last Update Posted: Nov 9, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yu-Jung Tsai, Doctoral student, National Taiwan Normal University: HIIT; executive function; ADHD; chronic exercise

Study Results

No Results Posted as of Nov 9, 2020