UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044480 |
|---|---|
| Receipt number | R000050816 |
| Scientific Title | A prospective study for associations of physical fitness and health behaviors to cognitive function and academic performance in children and adolescents in Hokkaido, Japan. |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2025/05/20 12:58:29 |
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Basic information
Public title
A prospective study for associations of physical fitness and health behaviors to cognitive function and academic performance in children and adolescents in Hokkaido, Japan.
Acronym
Brain Up by Sports and Health Improvement for children in HokkaiDo 2 (BUSHIDO2)
Scientific Title
A prospective study for associations of physical fitness and health behaviors to cognitive function and academic performance in children and adolescents in Hokkaido, Japan.
Scientific Title:Acronym
Brain Up by Sports and Health Improvement for children in HokkaiDo 2 (BUSHIDO2)
Region
| Japan |
Condition
Condition
Cognitive function
Academic performance
Sociality
Physical fitness
Body weight status
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this prospective study is to determine the influences of physical fitness, weight status (obesity/underweight), social and daily behaviors on the cognitive function and academic performance in Japanese elementary school children.
Basic objectives2
Others
Basic objectives -Others
1. To determine growth trends of cognitive function in children of Hokkaido, Japan.
2. To investigate associations relationships of physical fitness, weight status, and social and daily behaviors to cognitive function and academic performance in children.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive function
Academic performance
Key secondary outcomes
Social behaviors
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/guardian consent
2. 3rd to 6th grades
3. Capable of performing exercise
4. Absence of neurodevelopmental disorders
Key exclusion criteria
1. Non-consent of parent/guardian
2. Above or below age range
3. Any physical disability that prohibits exercise
4. Neurodevelopmental disorders
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Noriteru |
| Middle name | |
| Last name | Morita |
Organization
Hokkaido University of Education
Division name
Dept. Art and Sport Cultural Studies
Zip code
068-8642
Address
2-34-1 Midorigaoka, Iwamizawa, Hokkaido
TEL
0126-32-0393
morita.noriteru@i.hokkyodai.ac.jp
Public contact
Name of contact person
| 1st name | Noriteru |
| Middle name | |
| Last name | Morita |
Organization
Hokkaido University of Education
Division name
Dept. Art and Sport Cultural Studies
Zip code
068-8642
Address
2-34-1 Midorigaoka, Iwamizawa, Hokkaido
TEL
0126-32-0393
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
Other related organizations
Co-sponsor
Chukyo University
Kobe University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University of Education
Address
5-3 Ainosato, Kita-ku, Sapporo, Hokkaido
Tel
011-778-0649
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
| 2021 | Year | 06 | Month | 21 | 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
| 2020 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this prospective study is to determine the influences of physical fitness, weight status (obesity/underweight), social and daily behaviors on cognitive function, and academic performance in Japanese elementary school children.
Main outcome: Cognitive function and Academic performance
Measurement variables: Physical fitness, body weight status, social behaviors, lifestyle behaviors.
These variables are measured once a school year.
Management information
Registered date
| 2021 | Year | 06 | Month | 09 | 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=R000050816
