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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040521
Receipt No. R000046255
Scientific Title Study of theremal stress with mask during exercise in summer.
Date of disclosure of the study information 2020/06/10
Last modified on 2020/05/26

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Basic information
Public title Study of theremal stress with mask during exercise in summer.
Acronym Study of theremal stress with mask during exercise in summer.
Scientific Title Study of theremal stress with mask during exercise in summer.
Scientific Title:Acronym Study of theremal stress with mask during exercise in summer.
Region
Japan

Condition
Condition normal Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Mask wear is emphasized as an infection prevention measure, but the heat exhaustion risk which can be put under the summer summer heat environment is uneasy, but I have for my object to do the stress value of the wear at the summer heat bottom because the thermal stress value with the mask wear isn't indicated.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The body exposued the acute heat stress environments for 1 hour. We estimate effects of the acute heat exposure. Heart rate, sweat volume, body temperature, thermal sensation, thermal confortable.
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 1hour
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
25 years-old >=
Gender Male
Key inclusion criteria healthy adult men
Key exclusion criteria Abnormality by a physical check-up
Target sample size 8

Research contact person
Name of lead principal investigator
1st name HIDETO
Middle name
Last name TANAKA
Organization Yokohama National University
Division name Faculty of Education
Zip code 240-8501
Address Hodogaya-ku, Tokiwadai 79-2, Yokohama, Japan
TEL 045-339-3277
Email tanaka-hideto-ht@ynu.ac.jp

Public contact
Name of contact person
1st name HIDETO
Middle name
Last name TANAKA
Organization Yokohama National University
Division name Faculty of Education
Zip code 240-8501
Address Hodogaya-ku Tokiwadai 79-1, Yokohama, Japan
TEL 045-339-3277
Homepage URL
Email tanaka-hideto-ht@ynu.ac.jp

Sponsor
Institute Yokohama National University
Research general affairs department
Institute
Department

Funding Source
Organization Yokohama National University
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 Yokohama National University
Address Hodogaya-ku Tokiwadai 79-2, Yokohama
Tel 045-339-3277
Email tanaka-hideto-ht@ynu.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
2020 Year 06 Month 10 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 05 Month 26 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 10 Day
Last follow-up date
2020 Year 12 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 05 Month 26 Day
Last modified on
2020 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046255

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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