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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033103
Receipt No. R000037745
Scientific Title Occupational Safety and Health Study on Elucidation of Karoshi and Prevention Measures
Date of disclosure of the study information 2018/06/22
Last modified on 2019/06/24

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Basic information
Public title Occupational Safety and Health Study on Elucidation of Karoshi and Prevention Measures
Acronym Mechanism of cardiovascular burden caused by long working hour
Scientific Title Occupational Safety and Health Study on Elucidation of Karoshi and Prevention Measures
Scientific Title:Acronym Mechanism of cardiovascular burden caused by long working hour
Region
Japan

Condition
Condition Healthy and grade 1 hypertension adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effects of long working hours on cardiovascular response and reduction of cardiovascular burden.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Cardiovascular responses and subjective evaluation.
Key secondary outcomes blood pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, subjective stress, fatigue and sleepiness.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
30 years-old <=
Age-upper limit
65 years-old >
Gender Male
Key inclusion criteria normotensive and grade 1 hypertension male adults.
Key exclusion criteria Heart disease, diabetes, asthma, stroke, chronic kidney disease
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Xinxin
Middle name
Last name Liu
Organization National Institute of Occupational Safety and Health, Japan.
Division name Occupational Epidemiology Research Group
Zip code 214-8585
Address Nagao 6-21-1, Tama-ku, Kawasaki, Kanagawa 214-8585, Japan.
TEL 81448656111
Email liu@h.jniosh.johas.go.jp

Public contact
Name of contact person
1st name Xinxin
Middle name
Last name Liu
Organization National Institute of Occupational Safety and Health, Japan.
Division name Occupational Epidemiology Research Group
Zip code 214-8585
Address Nagao 6-21-1, Tama-ku, Kawasaki, Kanagawa 214-8585, Japan.
TEL 81448656111
Homepage URL
Email liu@h.jniosh.johas.go.jp

Sponsor
Institute National Institute of Occupational Safety and Health, Japan.
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare, Japan.
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 National Institute of Occupational Safety and Health, Japan.
Address Nagao 6-21-1, Tama-ku, Kawasaki, Kanagawa 214-8585, Japan.
Tel 044-865-6111
Email liu@h.jniosh.johas.go.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 独立行政法人 労働者健康安全機構 労働安全衛生総合研究所

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information Measured cardiovascular responses and subjective evaluation.

Management information
Registered date
2018 Year 06 Month 22 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037745

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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