UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060099 |
|---|---|
| Receipt number | R000068730 |
| Scientific Title | Verification of cold water immersion using a heatstroke relief bag for core body temperature rise caused by exercise in a hot environment |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/16 15:08:24 |
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Basic information
Public title
To investigate the effectiveness of cooling body temperature raised by exercise in a hot environment with cold water using a heatstroke relief bag
Acronym
The effect of cooling body temperature raised by exercise in a hot environment with cold water
Scientific Title
Verification of cold water immersion using a heatstroke relief bag for core body temperature rise caused by exercise in a hot environment
Scientific Title:Acronym
Verification of cold water immersion method for body temperature rise due to exercise in a hot environment
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to verify the effectiveness of a heatstroke relief bag, which is relatively easy to prepare and practical, and a 10-minute cold water immersion method using a small amount (5 or 80 L) of cold water (approximately 5 degree) or tap water (approximately 20 degree) on core body temperature that has risen due to exercise in a hot environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The core body temperature is measured using a capsule thermometer after immersion in cold water for 10 minutes, and the cooling temperature per minute (cooling rate) is calculated and evaluated.
Key secondary outcomes
Heart rate and skin temperature are measured during cold water immersion to evaluate the relationship with core body temperature.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The subjects entered an environmentally controlled room set at a temperature of 40 degree and humidity of 60%, sat in a chair and rested for five minutes, then walked for three minutes on a treadmill set at a speed of 5 km/h and a 2% incline as a warm-up.
They then ran for 30 minutes on a treadmill set at a speed of 8-9 km/h and a 2% incline. After finishing the run, the subjects lay supine in a heatstroke aid bag and were immersed in water cooled to approximately 5 degree, which was poured over them at a constant rate, for a total of 10 minutes.
Interventions/Control_2
The subjects entered an environmentally controlled room set at a temperature of 40 degree and humidity of 60%, sat in a chair and rested for five minutes, then walked for three minutes on a treadmill set at a speed of 5 km/h and a 2% incline as a warm-up.
They then ran for 30 minutes on a treadmill set at a speed of 8-9 km/h and a 2% incline. After finishing the run, the subjects lay supine in a heatstroke aid bag and were immersed in 80 liters of water cooled to approximately 20 degree, which was poured over them at a constant rate, for a total of 10 minutes.
Interventions/Control_3
Subjects entered an environmentally controlled room set at a temperature of 40 degree and humidity of 60%. They sat in a chair and rested for five minutes, then performed a three-minute warm-up walk on a treadmill set at a speed of 5 km/h and a 2% incline.
Subjects then ran for 30 minutes on a treadmill set at a speed of 8-9 km/h and a 2% incline. After completing the run, subjects sat in a chair and rested for 10 minutes.
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
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Male individuals aged 18-29.
2) Persons who can fully understand the purpose and sign the consent form.
3) Persons who can comply with the intervention.
Key exclusion criteria
1) Chronic health problems
2) A history of heatstroke this fiscal year
3) A history of cardiovascular, metabolic, or respiratory disease
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuwano |
Organization
Ninebird Co., Ltd.
Division name
Sales Management Division
Zip code
5420081
Address
Yusei Hukusi Shinsaibashi Building 8th floor, 3-11-18 Minamisenba, Chuo-ku, Osaka City,Osaka
TEL
0677771550
kuwano@n-bird.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuwano |
Organization
Osaka University of Health and Sport Sciences
Division name
School of Sport Sciences
Zip code
5900496
Address
1-1 Asashirodai, Kumatori-cho, Sennan-gun, Osaka
TEL
0724537022
Homepage URL
kuwano@n-bird.com
Sponsor or person
Institute
Osaka University of Health and Sport Sciences
Institute
Department
Personal name
Funding Source
Organization
Ninebird Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University of Health and Sport Sciences
Address
1-1 Asashirodai, Kumatori-cho, Sennan-gun, Osaka
Tel
0724537022
kuwano@n-bird.com
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 | 12 | Month | 22 | 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
| 2025 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 12 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068730
