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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023215
Receipt No. R000026761
Scientific Title Effects of combination exercises on electroencephalography and frontal lobe executive function measures in children with ADHD
Date of disclosure of the study information 2016/07/18
Last modified on 2016/07/18

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Basic information
Public title Effects of combination exercises on electroencephalography and frontal lobe executive function measures in children with ADHD
Acronym Exercise and children with ADHD
Scientific Title Effects of combination exercises on electroencephalography and frontal lobe executive function measures in children with ADHD
Scientific Title:Acronym Exercise and children with ADHD
Region
Asia(except Japan)

Condition
Condition Attention-deficit hyperactivity disorder
Classification by specialty
Neurology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study was to investigate the effects of exercise on neuropsychological variables of executive function and physiological variables with electroencephalography in children with attention-deficit hyperactivity disorder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes neuropsychological variables of executive function and physiological variables with electroencephalography
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The program consisted of 60 min of exercise (10-min warm-up, 40-min main exercise, and 10-min cool down), and it was performed three times a week for 12 weeks.
Interventions/Control_2 control group - free-living activity
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
8 years-old <=
Age-upper limit
13 years-old >
Gender Male
Key inclusion criteria 1) Children who obtained the approval of the tending physicians and parents for participation in the exercise program;
2) Children who met the diagnostic criteria for ADHD in the Diagnostic and Statistical Manual of Mental Disorders, version IV
Key exclusion criteria 1) Children who had participated in regular exercise for the previous 6 months.
2) Children with current or previous history of medication or other therapies for ADHD and who were free of other psychological disorders
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jong-Hwan Park
Organization Dong-A University
Division name Institute of Covergence Bio-Health
Zip code
Address 32, Daeshingongwon-Ro, Seo-Gu, Busan, 602-715 Rep. of Korea
TEL +82-52-240-2763
Email jpark@dau.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Jong-Hwan Park
Organization Dong-A University
Division name Institute of Covergence Bio-Health
Zip code
Address 32, Daeshingongwon-Ro, Seo-Gu, Busan, 602-715 Rep. of Korea
TEL +82-52-240-2763
Homepage URL
Email jpark@dau.ac.kr

Sponsor
Institute Dong-A University
Institute
Department

Funding Source
Organization Dong-A University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 18 Day
Last modified on
2016 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026761

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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