UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030196 |
|---|---|
| Receipt number | 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 16:32:14 |
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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
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
khayashi@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Junior College, University of Shizuoka
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034493
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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