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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030196
Receipt No. R000034493
Scientific Title Effect of increase in body temperature during exercise on respiratory chemosensitivity
Date of disclosure of the study information 2017/12/01
Last modified on 2018/05/31

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Basic information
Public title Effect of increase in body temperature during exercise on respiratory chemosensitivity
Acronym Effect of increase in body temperature during exercise on respiratory chemosensitivity
Scientific Title Effect of increase in body temperature during exercise on respiratory chemosensitivity
Scientific Title:Acronym Effect of increase in body temperature during exercise on respiratory chemosensitivity
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clear the effect of increase in body temperature during exercise on respiratory chemosensitivity
Basic objectives2 Others
Basic objectives -Others Comparison between respiratory chemosensitivity during exercise before body temperature increases and that after body temperature increases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes body temperature
minute ventilation
end-tidal CO2 pressure
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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Cool or heat to change body temperature during exercise. Body temperature is increased up to 1 degree Celsius.
Evaluate respiratory chemosensitivity to rebreath.
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

Not applicable
Gender Male
Key inclusion criteria Written informed consent.
Key exclusion criteria Not have serious underlying disease
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiji Hayashi
Organization University of Shizuoka
Division name Junior College
Zip code
Address 2-2-1 Oshika, Suruga-ku, Shizuoka, 422-8021, JAPAN
TEL +81-54-202-2639
Email khayashi@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiji Hayashi
Organization University of Shizuoka
Division name Junior College
Zip code
Address 2-2-1 Oshika, Suruga-ku, Shizuoka, 422-8021, JAPAN
TEL +81-54-202-2639
Homepage URL
Email khayashi@u-shizuoka-ken.ac.jp

Sponsor
Institute Junior College, University of Shizuoka
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Shizuoka University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 16-14
Org. issuing International ID_1 Shizuoka University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 12 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
2017 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2018 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
2017 Year 11 Month 30 Day
Last modified on
2018 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034493

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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