UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031256 |
|---|---|
| Receipt number | R000035688 |
| Scientific Title | Influence of exercise performance with combination of exercise training and hot water bath in temperature condition. |
| Date of disclosure of the study information | 2018/02/13 |
| Last modified on | 2022/08/24 21:44:23 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035688
