UMIN-CTR Clinical Trial

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