UMIN-CTR Clinical Trial

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	90
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	Completed
Date of protocol fixation	2016 Year 03 Month 31 Day
Date of IRB	2016 Year 03 Month 31 Day
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	2021 Year 01 Month 07 Day

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