UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033103
Receipt number 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 2021/01/07 11:05:21

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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 or person

Institute

National Institute of Occupational Safety and Health, Japan.

Institute

Department

Personal name



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

Value
https://center6.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