UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032614 |
|---|---|
| Receipt number | R000037188 |
| Scientific Title | Prospective study for associations between cognitive development, physical fitness, and health behaviors in children and adolescents in Hokkaido, Japan. |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2025/05/20 12:58:51 |
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Basic information
Public title
Prospective study for associations between cognitive development, physical fitness, and health behaviors in children and adolescents in Hokkaido, Japan.
Acronym
Brain Up by Sports and Health Improvement for children in HokkaiDo (BUSHI-DO)
Scientific Title
Prospective study for associations between cognitive development, physical fitness, and health behaviors in children and adolescents in Hokkaido, Japan.
Scientific Title:Acronym
Brain Up by Sports and Health Improvement for children in HokkaiDo (BUSHI-DO)
Region
| Japan |
Condition
Condition
Executive function
Physical fitness
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this prospective study was to determine the influences of physical fitness, weight status (obesity/underweight), and exercise habits on the developmental growth of cognitive function of Japanese elementary and junior high school students and to elucidate the implications of fitness/exercise habits in the developmental growth of cognitive function during childhood.
Basic objectives2
Others
Basic objectives -Others
1) Growth trends of cognitive function
2) Relationships of cognitive function with physical fitness, weight status, and exercise habits in children
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Higher order cognitive function (executive function): inhibitory control and working memory
Key secondary outcomes
Physical fitness
Weight status (obesity and underweight)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Parental consent
2) Third to 6th grade elementary school and junior high school children
3) Capable of performing exercises
4) Absence of school-identified learning disability and ADHD
Key exclusion criteria
1) Non-consent of guardian
2) Above or below the age range
3) Any physical disability that prohibits exercise
4) School-identified learning disability and ADHD
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Morita |
| Middle name | |
| Last name | Noriteru |
Organization
Hokkaido University of Education, Iwamizawa
Division name
Dept. Art and Sport Cultural Studies
Zip code
068-8642
Address
2-34-1 Midorigaoka, Iwamizawa, Hokkaido, Japan
TEL
0126-32-0250
morita.noriteru@i.hokkyodai.ac.jp
Public contact
Name of contact person
| 1st name | Morita |
| Middle name | |
| Last name | Noriteru |
Organization
Hokkaido University of Education
Division name
Dept. Art and Sport Cultural Studies
Zip code
0688642
Address
2-34-1 Midorigaoka, Iwamizawa, Hokkaido
TEL
0126-32-0250
Homepage URL
morita.noriteru@i.hokkyodai.ac.jp
Sponsor or person
Institute
Hokkaido University of Education
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University of Education
Address
1-3 Ainosato 5-3, Kita-ku, Sapporo, Japan
Tel
011-778-0206
s-kenkyu@j.hokkyodai.ac.jp
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
| 2018 | Year | 06 | Month | 01 | 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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This longitudinal study evaluates associations of growth trends of physical fitness and weight status with the developmental growth of executive function of Japanese elementary and junior high school students. This study is ongoing and will be completed in March 2021.
Management information
Registered date
| 2018 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037188
