UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of high intensity short term heat acclimation protocol with fan cooling on physiological adaptation
Title of the study (Brief title)	The effect of heat acclimation protocol with fan cooling
Region	Japan

Condition
Condition	Healthful people don't adapt to heat stress on hot environment
Classification by specialty	Medicine in general Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study are to examine the effect of high-intensity and short-term heat acclimation on physiological adaptation and the effect of fan-cooling on a degree of adaptation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcome is variation of rectal temperature in a Heat Tolerance Test was developed by the Heller Institute of Medical Research.
Key secondary outcomes	Key secondary outcomes are variation of heart rate, skin blood flow, mean skin temperature, sweat rate, and subjective date in a Heat Tolerance Test.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The intervention period in six days include five training sessions and a rest day. The training sessions consists of 10minutes exercise at bike ergometer and 5minutes rest in hot environment (35degree, 30%RH). All subjects drink water and cool themselves with fan at rest.
Interventions/Control_2	The intervention period in six days include five training sessions and a rest day. The training sessions consists of 10minutes exercise at bike ergometer and 5minutes rest in hot environment (35degree, 30%RH). All subjects only drink water at rest.
Interventions/Control_3	The intervention period in six days include five training sessions and a rest day. The training sessions consists of 10minutes exercise at bike ergometer and 5minutes rest in normal environment (20degree, 50%RH). All subjects only drink water at rest.
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	29 years-old >=
Gender	Male
Key inclusion criteria	Healthful adult men
Key exclusion criteria	1. had a cardiovascular, liver, kidney, metabolic, or pulmonary disease 2. currently used any tobacco product 3. were heavy caffeine users, ie, .500 mg per day 4. were heat acclimatized during physical training within the past a month
Target sample size	30

Research contact person
Name of lead principal investigator	Hirose Norikazu
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	#75-2-208 Waseda university 2-7-5, Higashifushimi, Nishitokyo, Tokyo, Japan 202-0021
TEL	042-461-1322
Email	toitsu_hirose@waseda.jp

Public contact
Name of contact person	Masuda Yuta
Organization	Waseda University
Division name	Graduated School of Sport Sciences, Waseda University
Address	#75-2-208 Waseda university 2-7-5, Higashifushimi, Nishitokyo, Tokyo, Japan 202-0021
TEL	080-2593-2466
Homepage URL
Email	masuda-19@fuji.waseda.jp

Sponsor
Institute	Graduated School of Sport Sciences, Waseda University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2016 Year 10 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 25 Day
Last modified on	2016 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028267