UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of an increase and a decrease in cardiac filling pressure on muscle and skin sympathetic nerve activity during passive warming in humans
Title of the study (Brief title)	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	Hiroshi Nose
Organization	Shinshu University Graduate School of Medicine
Division name	Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
Address	Asahi 3-1-1, matsumoto, Japan
TEL	0263-37-2681
Email	nosehir@shinshu-u.ac.jp

Public contact
Name of contact person	Yoshi-ichiro Kamijo
Organization	Shinshu University Graduate School of Medicine
Division name	Department of Sports Medical Sciences, Institute of Pathogenesis and Disease Prevention
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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