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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031813
Receipt No. R000036318
Scientific Title Research on evaluation of developed new-functionality underclothes using new material
Date of disclosure of the study information 2018/04/01
Last modified on 2019/09/24

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Basic information
Public title Research on evaluation of developed new-functionality underclothes using new material
Acronym Research on evaluation of developed new-functionality underclothes using new material
Scientific Title Research on evaluation of developed new-functionality underclothes using new material
Scientific Title:Acronym Research on evaluation of developed new-functionality underclothes using new material
Region
Japan

Condition
Condition Healthy adult males
Classification by specialty
Cardiovascular surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate windbreak performance, hold warmth, and moisture vapor permeability of new-functionality underclothes compared with ready-made materials.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Inner temperature and humidity, surface temperature and heat flux, and thermogorapgh of new-functionality underclothes and intermediate clothes
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 Wearing new-functionality underclothes.
Sitting at rest (3-10m/s of wind velosity) + walking (3m/s of fixed wind velosity, 40-120m/min of walking speed) at 10 degrees C for 30 minutes, respectively.
Interventions/Control_2 Wearing ready-made underclothes.
Sitting at rest (3-10m/s of wind velosity) + walking (3m/s of fixed wind velosity, 40-120m/min of walking speed) at 10 degrees C for 30 minutes, respectively.
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
40 years-old >
Gender Male
Key inclusion criteria 1)Age <= 20yaers old to > 40years old at the time if informed consent
2)Volunteers who are fully informed of and understand the objectives, procedures, and possible risks of the study and provide the written voluntary consent to participate in the study.
Key exclusion criteria 1)Diseases which need physical work restriction
2)Cardiovascular diseases, arrhhythmia
3)Hypertension (resting blood presure, SBP > or = 140 mmHg, DBP > or = 90mmHg)
4)Metabolic and endcrine disease
5)Smokers
6)Obesity (BMI <= 30kg/m2)
7)Ineligible by a medical interview
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Daiki
Middle name
Last name Imai
Organization Osaka City University Graduate School of Medicine
Division name Environmental Physiology for Exercise
Zip code 5588585
Address 3-3-138, Sugimoto, Sumiyoshi, Osaka
TEL 06-6605-2946
Email dimai@sports.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Imai
Middle name
Last name Daiki
Organization Osaka City University Graduate School of Medicine
Division name Environmental Physiology for Exercise
Zip code 5588585
Address 3-3-138, Sugimoto, Sumiyoshi, Osaka
TEL 06-6605-2946
Homepage URL
Email dimai@sports.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization AS corporation
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 The Ethics Committee of Osaka City University Graduate School of Medicine
Address 1-2-7,Asahi-machi,Abeno-ku,Osaka
Tel 06-6645-3435
Email ethics@med.osaka-cu.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
2018 Year 04 Month 01 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
2018 Year 02 Month 22 Day
Date of IRB
2018 Year 02 Month 27 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2021 Year 03 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
2018 Year 03 Month 20 Day
Last modified on
2019 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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