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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041114
Receipt No. R000046954
Scientific Title Study on body composition and function of working generation
Date of disclosure of the study information 2020/07/15
Last modified on 2020/07/15

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Basic information
Public title Study on body composition and function of working generation
Acronym Study on body composition and function of working generation
Scientific Title Study on body composition and function of working generation
Scientific Title:Acronym Study on body composition and function of working generation
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the characteristics of worker's behavioral strength and lifestyle habits
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body composition
grip strength
2-step test
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Body composition
grip strength
2-step test
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2)Working people
3)Adults over 20 years old
Key exclusion criteria 1)persons under 20
2) persons who did not get consent
3) persons who are judged to be inappropriate for inclusion in the study by the principal investigator / partner and the medical staff involved in the study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Kitagawa
Middle name
Last name Hitomi
Organization Kinki Health Administration Center (KKC)
Division name Medical practice management unit
Zip code 520-0812
Address 10-10 Kinoshita-cho, Ootsu, Shiga 520-0812, JAPAN
TEL 050-3530-4268
Email h_kitagawa@zai-kkc.or.jp

Public contact
Name of contact person
1st name Takariki
Middle name
Last name Yoko
Organization Kinki Health Administration Center (KKC)
Division name Corporate Planning Group
Zip code 520-0812
Address 10-10 Kinoshita-cho, Ootsu, Shiga 520-0812, JAPAN
TEL 077-525-5412
Homepage URL
Email y_takariki@zai-kkc.or.jp

Sponsor
Institute Kinki Health Administration Center
Institute
Department

Funding Source
Organization Kinki Health Administration Center
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 Central Research Ethic Committee, Kinki Health Administration Center
Address 10-10 Kinoshita-cho, Ootsu, Shiga 520-0812, JAPAN
Tel 077-525-5418
Email t_hachio@zai-kkc.or.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
2020 Year 07 Month 15 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
2020 Year 07 Month 14 Day
Date of IRB
2020 Year 07 Month 14 Day
Anticipated trial start date
2020 Year 07 Month 16 Day
Last follow-up date
2022 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
2020 Year 07 Month 15 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046954

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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