UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024560
Receipt number R000028267
Scientific Title The effect of high intensity short term heat acclimation protocol with fan cooling on physiological adaptation
Date of disclosure of the study information 2016/10/25
Last modified on 2016/10/25 15:11:44

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Basic information

Public title

The effect of high intensity short term heat acclimation protocol with fan cooling on physiological adaptation

Acronym

The effect of heat acclimation protocol with fan cooling

Scientific Title

The effect of high intensity short term heat acclimation protocol with fan cooling on physiological adaptation

Scientific Title:Acronym

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

1st name
Middle name
Last name Hirose Norikazu

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


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

1st name
Middle name
Last name Masuda Yuta

Organization

Waseda University

Division name

Graduated School of Sport Sciences, Waseda University

Zip code


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 or person

Institute

Graduated School of Sport Sciences, Waseda University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


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

Open public recruiting

Date of protocol fixation

2016 Year 08 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028267


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name