UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023215 |
|---|---|
| Receipt number | 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 16:13:45 |
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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
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
jpark@dau.ac.kr
Sponsor or person
Institute
Dong-A University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026761
