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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name