UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047755
Receipt number 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 14:57:59

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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 or person

Institute

Department of Orthopaedic Surgery, Wakayama Medical University

Institute

Department

Personal name



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

Value
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