UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045338 |
|---|---|
| Receipt number | R000051775 |
| Scientific Title | The study of heat stress with mask during exercise in hot environment |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/09/03 12:08:44 |
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Basic information
Public title
Thermal stress during exercise with mask in hot environment
Acronym
Heat stress during exercise with mask
Scientific Title
The study of heat stress with mask during exercise in hot environment
Scientific Title:Acronym
Effect of mask on heat stress during exercise
Region
| Japan |
Condition
Condition
Healthy adult men
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose is to clarify the risk of heat stroke wearing a no-woven mask during exercise in hot environments.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart Rate, Body Temperature, Blood Pressure, Sweat Rate, Blood Oxygen %, Objective Thermal Sensation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
with mask
Interventions/Control_2
without mask
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
| 24 | years-old | >= |
Gender
Male
Key inclusion criteria
Those who do not have respiratory or cardiovascular diseases in the health examination and have exercise habits on a daily basis
Key exclusion criteria
Those who cannot do jogging exercise for 30 minutes
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
1760004
Address
Hodogaya-ku Tokiwadai 79-1, Yokohama, Japan
TEL
045-339-3277
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
tanaka-hideto-ht@ynu.ac.jp
Sponsor or person
Institute
Yokohama National University
Institute
Department
Personal name
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 Tokiwadai79-1, Yokohama, Japan
Tel
045-339-3277
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
| 2021 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051775
