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
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
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
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
