UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062800 |
|---|---|
| Receipt number | R000071296 |
| Scientific Title | Development of Exercises to Raise Core Body Temperature for Heatstroke Prevention |
| Date of disclosure of the study information | 2026/09/04 |
| Last modified on | 2026/09/03 13:25:13 |
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Basic information
Public title
Development of Exercises to Raise Core Body Temperature for Heatstroke Prevention
Acronym
Development of Exercises to Raise Core Body Temperature
Scientific Title
Development of Exercises to Raise Core Body Temperature for Heatstroke Prevention
Scientific Title:Acronym
Development of Exercises to Raise Core Body Temperature
Region
| Japan |
Condition
Condition
Adult/ Heatstroke
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines whether an exercise program developed to prevent heatstroke effectively raises core body temperature.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core tempreture
Key secondary outcomes
Heart rate
Blood pressure
Evaporation rate from skin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Exercise group
Performed Koji Awareness corrective exercises and paper balloon exercises for 20 minutes.
Interventions/Control_2
20 minutes of walking or running on a treadmill at a comfortable pace.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged 18 to 60 years
Able to provide written informed consent
No orthopedic, neurological, or internal medicine disorders within the past 3 months
Key exclusion criteria
Metabolic disease
Pregnancy
Individuals deemed unsuitable by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Murofushi |
Organization
Science Tokyo
Division name
GENTEN Research Center
Zip code
113-8510
Address
Yushima 1-5-45 Bunkyo-ku, Tokyo
TEL
03-5803-4364
murofushi.k.30e5@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Ohmi |
Organization
Science Tokyo
Division name
GENTEN Research Center
Zip code
113-8510
Address
Yushima 1-5-45 Bunkyo-ku, Tokyo
TEL
03-5803-4364
Homepage URL
oomi.t.c456@m.isct.ac.jp
Sponsor or person
Institute
Science Tokyo
Institute
Department
Personal name
Koji Murofushi
Funding Source
Organization
TOKYO metropolitan
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo Medical Research Ethics Committee
Address
Yushima 1-5-45 Bunkyo-ku, Tokyo
Tel
03-5803-4547
rinri.adm@tmd.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
| 2026 | Year | 09 | Month | 04 | 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
| 2026 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071296
