UMIN-CTR Clinical Trial

Basic information
Public title	Influence of exercise performance with combination of exercise training and hot water bath in temperature condition.
Acronym	Influence of exercise performance with combination of exercise training and hot water bath in temperature condition.
Scientific Title	Influence of exercise performance with combination of exercise training and hot water bath in temperature condition.
Scientific Title:Acronym	Influence of exercise performance with combination of exercise training and hot water bath in temperature condition.
Region	Japan

Condition
Condition	Healty adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is to examine whether daily hot water bath for 20 minutes after exercise in temp-erate conditions induces heat acclimation. Andalthough, to study the effect difference of 20 minutes and 40 minutes hot water bath.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	This study is to verify that daily hot water bath for 20 minutes after exercise in temperateconditions influences rectal temperature.
Key secondary outcomes	This study, the effect of exercise training under temperate conditions and the combination of hot water bath for 20 minutes conducted immediately thereafter influence other physiological indicators and subjective indicators etc.

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	6 days of consecutive training combined with hot water bath for 40 minutes immediately after the training.
Interventions/Control_2	6 days of consecutive training combined with hot water bath for 20 minutes immediately after the training.
Interventions/Control_3	6 days of consecutive training combined with setting on the chair for 20 minutes immediate-ly after the training.
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	30 years-old >
Gender	Male
Key inclusion criteria	Healthy male student aged 20+ enrolled in Waseda University
Key exclusion criteria	1. Have an visceral disease 2. Have a smoking habit 3. Had experienced onset of heat stroke 4. Having heat-acclimatized (3 days / week *100 minutes of heat exposure repeated in past month) 5.Being prohibited from movement by the physician 6. Have a orthopedic disease 7.Simultaneously participate in other inter-vention studies during the research period
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Isao Middle name Last name Muraoka
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code	3591192
Address	2-579-15 Mikajima, Tokorozawa,Saitama,359-1192
TEL	+08-4-2947-6725
Email	imuraoka@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	3591192
Address	2-579-15 Mikajima, Tokorozawa,Saitama,359-1192
TEL	+08-4-2947-7128
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	Japan

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	早稲田大学/Waseda University

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 13 Day

Related information
URL releasing protocol	https://mp.medicalonline.jp/products/article_list.php?magazine_code=dt4adexp&year=2020&volume=26&num
Publication of results	Published

Result
URL related to results and publications	https://mp.medicalonline.jp/products/article_list.php?magazine_code=dt4adexp&year=2020&volume=26&num
Number of participants that the trial has enrolled	16
Results	Heat acclimation was not induced by exercising under ambient temperature and a post-exercise 20mins hot water bath.  In addition to 40mins of exercising under ambient temperature, it was suggested that a hot water bath for 40mins or more is necessary to cause heat acclimation
Results date posted	2022 Year 08 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The participants were 16 healthy adult males aged 18 to 35 years with a regular schedule of exercising. The participants were non-smokers,with no known diseases, and were not taking any medication. Those with visceral and orthopedic diseases were excluded because they were at high risks as potential participants of the experiment. Besides, in order to avoid bias in the results of the experiment, therecruitment criteria also excluded those involved in other intervention studies during the study period, and those repeatedly exposed to heat for a duration of more than 100 minutes three times a week in the month before our study began.
Participant flow	The designed study was a combination of exercising in ambient temperature for 6 days and a hot water bath, with heat load tests being performed before and after the intervention. The subjects were divided into three groups: (i) Exercise only (EX + Rest20 group), (ii) Exercise followed by hot water bath for 20 minutes (EX + HWI20 group), and (iii) Exercise followed by hot water bath for 40 minutes (EX + HWI40 group).
Adverse events	no
Outcome measures	height body weight medical history and symptoms heart rate Rate of perceived exertion (RPE) thermal sensation sweat volume rectal temperature exercises times
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 13 Day
Date of IRB	2018 Year 02 Month 13 Day
Anticipated trial start date	2018 Year 02 Month 13 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	2018 Year 02 Month 12 Day
Last modified on	2022 Year 08 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035688