UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059944 |
|---|---|
| Receipt number | R000068557 |
| Scientific Title | Comparative study of physiological responses during heat tolerance between postmenopausal and premenopausal women |
| Date of disclosure of the study information | 2025/12/02 |
| Last modified on | 2025/12/02 12:43:53 |
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Basic information
Public title
Study on body response of postmenopausal and premenopausal women during exercise in hot environment
Acronym
Female Heat Response Study
Scientific Title
Comparative study of physiological responses during heat tolerance between postmenopausal and premenopausal women
Scientific Title:Acronym
Menopause heat tolerance study
Region
| Japan |
Condition
Condition
heat illness
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare thermoregulatory function between postmenopausal and premenopausal women during heat stress.
Basic objectives2
Others
Basic objectives -Others
An exploratory study to clarify thermoregulatory characteristics of postmenopausal and premenopausal women during exercise in a hot environment
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in rectal temperature, changes in heart rate, changes in skin temperature and mean skin temperature, onset time and rate of local sweating, and whole-body sweat loss
Key secondary outcomes
Body composition (height, weight, body fat percentage), hydration status (fluid intake, whole-body sweat loss), serum hormone levels, maximal oxygen uptake, sweat gland count, thermal sensation, rating of perceived exertion, and test duration
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Postmenopausal group inclusion criteria
-Age: 50-65 years
-BMI: 18.5-30 kg/m2
-At least 12 months have passed since the final menstrual period
-No hormone replacement therapy within the past 6 months
Premenopausal group inclusion criteria
-Age: 20-35 years
-BMI: 18.5-30 kg/m2
-Regular menstrual cycles (25-35 days, with variation within plus or minus 3 days)
-No hormonal medications within the past 3 months
Key exclusion criteria
Exclusion criteria (common to both groups)
-No history of heat illness
-Regular use of medications that affect thermoregulation
-History of major cardiovascular, respiratory, or metabolic diseases, including hypertension with systolic blood pressure >140 mmHg
-Presence of skin disorders or sweating dysfunction.
-Inability to provide informed consent
Target sample size
20
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
0429476770
yurihosokawa@waseda.jp
Public contact
Name of contact person
| 1st name | Yichang |
| Middle name | |
| Last name | Wang |
Organization
Waseda University
Division name
Graduate School of Sport Science
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa Saitama
TEL
0429476770
Homepage URL
wangyichang910@akane.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
NTT Communication Science Laboratories
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
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 | 12 | Month | 02 | 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 | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Currently under IRB review
Management information
Registered date
| 2025 | Year | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068557
