UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048101 |
|---|---|
| Receipt number | R000054822 |
| Scientific Title | Physical Examinations of Elementary and Junior High School Students in Katsuragi Town |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/06/19 23:41:59 |
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Basic information
Public title
Physical Examinations of Elementary and Junior High School Students in Katsuragi Town
Acronym
Katsuragi Children's Locomo Study
Scientific Title
Physical Examinations of Elementary and Junior High School Students in Katsuragi Town
Scientific Title:Acronym
Katsuragi Children's Locomo Study
Region
| Japan |
Condition
Condition
Locomotive Syndrome in Children
Classification by specialty
| Orthopedics | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the actual condition of "children's locomo," presentation of preventive and remedial measures, and verification of their effectiveness.
Basic objectives2
Others
Basic objectives -Others
Improvement of vitamin D deficiency status
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Results of physical ability tests on "Children's locomo": standing on one leg, bending forward, squatting, and raising upper limbs are evaluated once a year during the school year
Key secondary outcomes
25-OH vitamin D blood levels, bone mineral density, and results of new fitness tests
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Exercise, nutrition, and lifestyle modifications
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
| 6 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those currently enrolled in elementary or junior high school in Katsuragi Town, Wakayama Prefecture
Key exclusion criteria
Those not attending school
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamada |
Organization
Wakayama Medical University
Division name
Department of Orthopaedic Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300
yamacha@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hashizume |
Organization
Wakayama Medical University
Division name
Department of Orthopaedic Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama City
TEL
073-447-2300
Homepage URL
hashizum@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
| 2022 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2022 | Year | 06 | Month | 19 | Day |
Last modified on
| 2022 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054822
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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