UMIN-CTR Clinical Trial

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
Email	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
Email	hashizum@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054822