UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The development of an instrument equiped with an alamm system for firemen to prevent heat illness
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hiroshi Nose
Organization	Shinshu University
Division name	Graduate School of Medicine
Address	3-1-1 Asahi, Matsumoto
TEL	0263-37-2681
Email	nosehir@shinshu-u.ac.jp

Public contact
Name of contact person	Hiroshi Nose
Organization	Shinshu University
Division name	Graduate School of Medicine
Address	3-1-1 Asahi, Matsumoto
TEL	0263-37-2681
Homepage URL
Email	nosehir@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025702