UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022309 |
|---|---|
| Receipt number | R000025702 |
| Scientific Title | The development of an instrument equiped with an alamm system for firemen to prevent heat illness |
| Date of disclosure of the study information | 2016/05/14 |
| Last modified on | 2016/05/19 11:32:50 |
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Basic information
Public title
The development of an instrument equiped with an alamm system for firemen to prevent heat illness
Acronym
The development of a new suit for firemen
Scientific Title
The development of an instrument equiped with an alamm system for firemen to prevent heat illness
Scientific Title:Acronym
The development of a new suit for firemen
Region
| Japan |
Condition
Condition
Heat illness
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The development of an instrument equiped with an alarm system for firemen to prevent heat illness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between increases in exercise intensity and esophageal temperature during graded treadmill walking
Key secondary outcomes
The relationship between increases in exercise intensity, skin temperature, heart rate, arterial blood pressure, and oxygen consumption rate during graded treadmill walking
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The relationship between increases in exercise intensity and esophageal temperature is determined by having subjects walk on a treadmill while walking speed is increased every 3 minutes. The total time needed for the measurements is about 30 min. The experiment is conducted generally once for individual subjects.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male adults
Key exclusion criteria
Smokers and patients with life-style related diseases. Those who the investigators judge inappropriate as subjects for the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
Address
3-1-1 Asahi, Matsumoto
TEL
0263-37-2681
nosehir@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
Address
3-1-1 Asahi, Matsumoto
TEL
0263-37-2681
Homepage URL
nosehir@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Teijin Limited
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
Address
Tel
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
| 2016 | Year | 05 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 14 | Day |
Last modified on
| 2016 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025702
