UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057439 |
|---|---|
| Receipt number | R000065629 |
| Scientific Title | Practical Study on Heat Acclimatization Training Using Intermittent Heat Exposure in Japanese Firefighters |
| Date of disclosure of the study information | 2025/03/28 |
| Last modified on | 2025/09/27 09:09:31 |
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Basic information
Public title
Practical Study on Heat Acclimatization Training Using Intermittent Heat Exposure in Japanese Firefighters
Acronym
Heat Acclimatization Training in Fire Fighters
Scientific Title
Practical Study on Heat Acclimatization Training Using Intermittent Heat Exposure in Japanese Firefighters
Scientific Title:Acronym
Heat Acclimatization Training in Fire Fighters
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is well known that heat stress during firefighting activities is extremely high, and it is considered necessary to implement heat acclimatization training in Japanese fire services. Various heat acclimatization protocols have been developed and tested for their effectiveness in Japanese fire services. However, most existing protocols were carried out indoors, such as in controlled environment rooms, for consecutive days. This presents challenges for field implementation (e.g., inability to train every day, lack of access to laboratories). Therefore, the purpose of this study was to examine the effectiveness of intermittent heat acclimatization training for Japanese fire services in outdoor environments.
Additionally, we aim to examine the shift of sodium contents in participants' sweat, and explore its validity as a surrogate measure for heat acclimatization evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At pre- and post- four-week heat acclimatization training, we will examine the following variables: improvement in the 20m shuttle run test, decrease in sodium levels in sweat, presence or absence of a reduction in resting deep body temperature.
Key secondary outcomes
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Completion of heat acclimatization training while wearing firefighting suit
Interventions/Control_2
Completion of heat acclimatization training while wearing light clothes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
A healthy male who does not have orthopedic or internal medical conditions that would significantly interfere with exercise
Key exclusion criteria
Individuals with orthopedic or internal medical conditions significantly interfering with exercise, females, those deemed unable to undergo deep body temperature measurement using temperature sensor pills, and individuals with iodine allergies
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yuri |
| Middle name | |
| Last name | Hosokawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6770
yurihosokawa@waseda.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Hosokawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6770
Homepage URL
yurihosokawa@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Athletic Training Research Grant, Fund for Local Government Employees' Accident Compensation
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
Waseda University Office of Research Ethics
Address
1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
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
| 2025 | Year | 03 | Month | 28 | 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
12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Estimated core body temperature, heart rate, sweat volume and fluid intake during training, number of completed 20-m shuttle runs, and sweat sodium concentration measured only in the first and last trials
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2025 | Year | 03 | Month | 28 | Day |
Last modified on
| 2025 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065629
