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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003887
Receipt No. R000004679
Scientific Title Effects of an increase and a decrease in cardiac filling pressure on muscle and skin sympathetic nerve activity during passive warming in humans
Date of disclosure of the study information 2014/07/08
Last modified on 2018/06/21

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Basic information
Public title Effects of an increase and a decrease in cardiac filling pressure on muscle and skin sympathetic nerve activity during passive warming in humans
Acronym Muscle and skin sympathetic nerve activity during Valsalva's maneuver or continuous negative-pressure breathing
Scientific Title Effects of an increase and a decrease in cardiac filling pressure on muscle and skin sympathetic nerve activity during passive warming in humans
Scientific Title:Acronym Muscle and skin sympathetic nerve activity during Valsalva's maneuver or continuous negative-pressure breathing
Region
Japan

Condition
Condition Heat stroke
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is well-known that an incarese or decrease in venous return to the heart due to an increase or decease in blood volume enhances or reduces cutaneous vasodilation in hyperthermic humans. The purpose of our study is to identify an efferent pathway for controlling skin blood flow.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin sympathetic nerve activity and skin blood flow during Valsalva's maneuver and continuos negative-pressure breathing.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Passive heating
Valsalva's maneuver
Continuos negative-pressure breathing
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
20 years-old <=
Age-upper limit
35 years-old >=
Gender Male
Key inclusion criteria Male subjects who desire to participate by voluntary agreement.
Key exclusion criteria #1. History of hepatic, thyroid, renal, metabolic, cardiovascular, or pulmonary diseases.
#2. To take any medicines regularly.
#3. History of smoking within a year.
#4. Abnormal ECG
#5. Sytolic or diastolic blood pressures over 130 mmHg or 85 mmHg
#6. Persons who should be excluded from the present study by doctor's judgement.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nose
Organization Shinshu University Graduate School of Medicine
Division name Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address Asahi 3-1-1, matsumoto, Japan
TEL 0263-37-2681
Email nosehir@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshi-ichiro Kamijo
Organization Shinshu University Graduate School of Medicine
Division name Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-2682
Homepage URL
Email yoshikmj@shinshu-u.ac.jp

Sponsor
Institute Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention, Shinshu University Graduate School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding 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
2014 Year 07 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2010 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 05 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
2010 Year 07 Month 08 Day
Last modified on
2018 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004679

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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