UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040221 |
|---|---|
| Receipt number | R000042537 |
| Scientific Title | Effectiveness verification of soccer kids program for infants |
| Date of disclosure of the study information | 2020/04/24 |
| Last modified on | 2022/01/21 09:11:42 |
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Basic information
Public title
Effectiveness verification of soccer kids program for infants
Acronym
Effectiveness verification of soccer kids program for infants
Scientific Title
Effectiveness verification of soccer kids program for infants
Scientific Title:Acronym
Effectiveness verification of soccer kids program for infants
Region
| Japan |
Condition
Condition
Child
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to measure the effect of soccer kids program by measuring physical activity and steps.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of physical activity and steps for 3 days including soccer kids program
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
One time, soccer kids program of about 60 minutes
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
| 4 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have obtained parental consent and have not refused to attach the measuring device
Key exclusion criteria
Those who did not get parental consent and have refused to wear the measuring device
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hiroki |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-gakuendai, Inzai - shi, Chiba
TEL
0476-98-1001
hirokinwater@gmail.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hiroki |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
244-0816
Address
769-24 Kamikuratacho, Totsuka-ku, Yokohama, Kanagawa
TEL
045-864-4990
Homepage URL
hirokinwater@gmail.com
Sponsor or person
Institute
Juntendo University
Faculty of Health and Sports Science
Institute
Department
Personal name
Funding Source
Organization
None
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
Juntendo University
Address
1-1 Hiraka-gakuendai, Inzai - shi, Chiba
Tel
0476-98-1001
ko-suzuki@juntendo.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
| 2020 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
https://www.shobix.co.jp/jssf/tempfiles/journal/2021/211.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.shobix.co.jp/jssf/tempfiles/journal/2021/211.pdf
Number of participants that the trial has enrolled
100
Results
Our findings suggest that the soccer kids' program has an effect on increasing physical activity a day in nursery school children, and the program may also increase physical activity of those who are not active in the outdoor activity program.
Results date posted
| 2022 | Year | 01 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were 38 children in the 5-year-old class and 29 children in the 4-year-old class in nursery schools.
Participant flow
Physical activity (moderate-to-vigorous physical activity: MVPA and step counts) was measured by using a uniaxial accelerometer (Lifecorder EX; Suzuken Co. Ltd, Nagoya, Japan). The physical activity measurement was performed for 3 days (from 9am to 12pm) of regular activity program day, outdoor activity program day, and soccer program day.
Adverse events
The purpose of this study was to clarify physical activity characteristics of the soccer kids program (Japan Football Association recommended program) by comparing with typical
daily activities in nursery school children. In particular, we focused on the differences among individuals and nursery schools.
Outcome measures
The physical activity(MVPA(min) and Steps)
Calculated CV
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 23 | Day |
Last modified on
| 2022 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042537
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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