UMIN-CTR Clinical Trial

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
Email	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
Email	chang.lili@fuji.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045061