UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056866 |
|---|---|
| Receipt number | R000064931 |
| Scientific Title | Verification of the improving effects of cooling wear on body temperature regulation during exercise in a warm environment |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/01/24 17:36:03 |
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Basic information
Public title
Verification of the suppressing effect of cooling wear on body temperature rise
Acronym
Verification of the effect of cooling wear
Scientific Title
Verification of the improving effects of cooling wear on body temperature regulation during exercise in a warm environment
Scientific Title:Acronym
Improving effects of cooling wear on body temperature regulation
Region
| Japan |
Condition
Condition
heat illness
Classification by specialty
| Medicine in general | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the suppressing effects of cooling wear on body temperature rise during exercise in a warm environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
esophageal temperature, skin temperature, subjective tempearture sensation
Key secondary outcomes
heart rate, skin blood flow, sweat rate, subjective exercise intensity senation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
cooling wear
Interventions/Control_2
normal wear
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Persons aged from 20 to 50 years old.
2) Persons who can exercise by bicycle
3) Persons whose written informed consent to participate in the study based on their free will has been obtained
Key exclusion criteria
1) Persons who do not clear the inclusion criteria
2) Persons who who show allergic reaction to cooling wear
3) Persons who are judged not appropriate for partipating the study by a primary investigator
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University Graduate School of Medicine
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2682
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano
TEL
0263-37-2682
Homepage URL
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Others
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
Shinshu University Graduate School of Medicine
Address
3-1-1 Asahi Matsumoto Nagano
Tel
0263-37-2527
mdrinri@shinshu-u.ac.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 | 02 | Month | 01 | 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 | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 01 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064931
