UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039513 |
|---|---|
| Receipt number | R000045061 |
| Scientific Title | The effect of a hot water immersion at normal ambient temperature on thermoregulatory function |
| Date of disclosure of the study information | 2020/02/17 |
| Last modified on | 2020/02/17 15:52:32 |
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Basic information
Public title
The effect of a hot water immersion at normal ambient temperature on thermoregulatory function
Acronym
The effect of a hot water immersion at normal ambient temperature on thermoregulatory function
Scientific Title
The effect of a hot water immersion at normal ambient temperature on thermoregulatory function
Scientific Title:Acronym
The effect of a hot water immersion at normal ambient temperature on thermoregulatory function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of hot water immersion alone on heat acclimation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Height
2.Weight
3.Body fat percentage
4.Rectal temperature
5.Skin temperature
6.Sublingual temperature
7.Tympanic temperature
8.Heart rate
9.Blood pressure
10.Cardiac output
11.Sweating volume
12.Sweat composition
13.Rating of perceived exertion
14.Thermal sensation
15.Maximum oxygen uptake
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
6 days of continuous hot water immersion
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Healthy 18-35 year old man
2.Those who have no change in their lifestyle
3.Person who has exercise habit
Key exclusion criteria
1.Have a smoking habit
2.Participate in other intervention studies during the research period
3.Having experienced onset of heat stroke
4.Person who are prohibited from movement by the physician
5. Having orthopedic disease
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Kanosue |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
Tokorozawa,Saitama,2-579-15
TEL
04-2947-6751
kanosue@waseda.jp
Public contact
Name of contact person
| 1st name | Lili |
| Middle name | |
| Last name | Chang |
Organization
Waseda University
Division name
Graduate School of Sport Sciences
Zip code
359-1192
Address
Tokorozawa,Saitama,2-579-15
TEL
04-2947-6751
Homepage URL
chang.lili@fuji.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Procedures concerning Research with Human Subjects
Address
1-104,Totsukamachi, Shinjuku-ku, Tokyo
Tel
03-3203-4141
rinri@list.waseda.jp
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
| 2020 | Year | 02 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 02 | Month | 17 | Day |
Last modified on
| 2020 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045061
