UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of increase in body temperature during exercise on respiratory chemosensitivity
Title of the study (Brief title)	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	Keiji Hayashi
Organization	University of Shizuoka
Division name	Junior College
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	Keiji Hayashi
Organization	University of Shizuoka
Division name	Junior College
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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