UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055945 |
|---|---|
| Receipt number | R000063935 |
| Scientific Title | Development of a new method for cooling the body during exercise in high-temperature environments |
| Date of disclosure of the study information | 2024/10/25 |
| Last modified on | 2025/10/09 10:36:58 |
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Basic information
Public title
Development of a new method for cooling the body during exercise in high-temperature environments
Acronym
Development of cooling methods for the body during exercise in high-temperature environments
Scientific Title
Development of a new method for cooling the body during exercise in high-temperature environments
Scientific Title:Acronym
Development of cooling methods for the body during exercise in high-temperature environments
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of exercise in a hot environment while holding ice on body temperature
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Deep body temperature, heart rate, exhaled gas, subjective fatigue, subjective thermal sensation, weight, salivary stress markers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Grab the ice
Interventions/Control_2
Don't hold the ice
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Healthy adults who are non-smokers and non-medication users
2. Individuals who have received a full explanation of the study, fully understood the explanation, and agreed to participate in the study in writing
Key exclusion criteria
1. People who smoke and take medication
2. People who have been advised by a doctor to stop exercising due to injury
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Kon |
Organization
Toyo University
Division name
Department of Health and Sports Sciences, Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11 Akabanedai, Kita-ku, Tokyo, Japan
TEL
03-5924-2865
kon@toyo.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Kon |
Organization
Toyo University
Division name
Department of Health and Sports Sciences, Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11 Akabanedai, Kita-ku, Tokyo, Japan
TEL
03-5924-2865
Homepage URL
kon@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Toyo 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
Human Ethics Committee of Toyo University
Address
2100, Kujirai, Kawagoe-shi, Saitama, Japan
Tel
049-239-1519
kon@toyo.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
| 2024 | Year | 10 | Month | 25 | 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
7
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 10 | 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
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063935
