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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047755
Receipt No. R000054443
Scientific Title Health Examination of Locomotive Organs in Katsuragi Town: A Prospective Study of the General Population
Date of disclosure of the study information 2022/05/16
Last modified on 2022/05/14

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Basic information
Public title Health Examination of Locomotive Organs in Katsuragi Town: A Prospective Study of the General Population
Acronym Katsuragi study
Scientific Title Health Examination of Locomotive Organs in Katsuragi Town: A Prospective Study of the General Population
Scientific Title:Acronym Katsuragi study
Region
Japan

Condition
Condition Health status of the locomotive organs
Classification by specialty
Orthopedics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Health promotion for local residents
Basic objectives2 Others
Basic objectives -Others Investigate the health status of locomotive organs of local residents and provide appropriate lifestyle guidance and medical consultation guidance as needed.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Locomo grade
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 YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 During the study period, a locomotor health examination will be conducted once a year. Two months after the checkup, the results will be returned to the participants, and individual guidance, including visits to medical institutions, will be provided.For those participants who agree, a health promotion program will be offered to provide exercise and nutritional guidance and to improve sleep quality.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adults residing in Katsuragi Town who have given consent to participate
Key exclusion criteria Unable to understand the contents of the medical questionnaire and unable to answer of their own volition
Target sample size 800

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 073-441-0645
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 073-441-0645
Homepage URL
Email hashizum@wakayama-med.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Wakayama Medical University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Japan Agency for Medical Research and Development
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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 City
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 05 Month 16 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 05 Month 01 Day
Date of IRB
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2027 Year 08 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 05 Month 14 Day
Last modified on
2022 Year 05 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054443

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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