UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of normobaric hypoxic exercise on dynamic cerebral autoregulation.
Title of the study (Brief title)	Effect of normobaric hypoxic exercise on dynamic cerebral autoregulation.
Region	Japan

Condition
Condition	Acute mountain sickness
Classification by specialty	Medicine in general Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The present study was designed to evaluate the effect of normobaric hypoxic exercise on dynamic cerebral autoregulation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Heart rate, blood pressure, stroke volume, SpO2, cerebral circulatory regulation, respiratory condition, and autonomic circulatory regulation are measured after supine rest more than 15 minutes as pre data of 6 minutes. Subjects exercise by bicycle ergometer for 30 minutes. Post data of 6 minutes are measured after 15 minutes supine rest.
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	Device,equipment
Interventions/Control_1	Subjects exercise by bicycle ergometer for 30 minutes inhaling 15% normobaric hypoxic oxygen.It is over more than one week,subjects exercise by bicycle ergometer for 30 minutes inhaling 21% normobaric oxygen.
Interventions/Control_2	Subjects exercise by bicycle ergometer for 30 minutes inhaling 21% normobaric oxygen.It is over more than one week,subjects exercise by bicycle ergometer for 30 minutes inhaling 15% normobaric hypoxic oxygen.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Healty adult consented to participate in this study.
Key exclusion criteria	Volunteers having medical problems and/or drugs.
Target sample size	20

Research contact person
Name of lead principal investigator	Ken-ichi Iwasaki/Ryo Yanagida
Organization	Nihon University School of Medicine
Division name	Division of Hygiene, Department of Social Medicine
Address	30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	iwasaki.kenichi@nihon-u.ac.jp

Public contact
Name of contact person	Ryo Yanagida
Organization	Nihon University School of Medicine
Division name	Division of Hygiene, Department of Social Medicine
Address	30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Homepage URL
Email	yanagida.ryo@nihon-u.ac.jp

Sponsor
Institute	Division of Hygiene, Department of Social Medicine, Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2015 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 18 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2018 Year 10 Month 18 Day
Date of closure to data entry	2018 Year 10 Month 18 Day
Date trial data considered complete	2018 Year 10 Month 18 Day
Date analysis concluded	2018 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 24 Day
Last modified on	2018 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022944