UMIN-CTR Clinical Trial

Basic information
Public title	The effects of widespread changes of gravity on circulation
Acronym	Gravity and circulation
Scientific Title	The effects of widespread changes of gravity on circulation
Scientific Title:Acronym	Gravity and circulation
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the effects of wide changes in gravity on circulation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cerebral autoregulation and baroreflex function during each level of gravity.
Key secondary outcomes	cerebral blood flow, arterial blood pressure, heart rate, stroke volume, respiratory condition, cerebral blood volume, cerebral metabolism, intracranial pressure.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Healthy seated men are exposed to widespread changes in gravity, by using a tilt chair and a short-arm human centrifuge. In the tilt chair protocol, subjects are exposed to 0, 0.5, and 1.0 Gz by adjusting the degree of tilt of the chair. The subject is seated in the tilt chair. The degree of tilt of the chair is adjusted to the horizontal (0 Gz), 30-degree head-up (0.5 Gz), and 90-degree head-up (1.0 Gz) positions. Data collection at each level of hypogravity (0, 0.5, and 1.0 Gz) is performed for 6 min from 15 min after initiation of exposure to each degree of tilt (15-21 min of 0, 0.5, or 1.0 Gz). In the centrifugation protocol, we maintains centrifugation at 24 rpm (1.5 Gz at the heart level of the subject) or 30 rpm (2.0 Gz at the heart level of the subject) for 21 min. Baseline 1.0 Gz data are collected for 6 min after 15 min of quiet rest in the centrifuge chair, following which the centrifugation is begun. Data collection at each level of hypergravity is performed for 6 min from 15 min after exposure to 1.5 or 2.0 Gz centrifugation (15-21 min of 1.5 and 2.0 Gz hypergravity).
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy human consented to participate in this study.
Key exclusion criteria	Not satisfy selection criteria noted above.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Ken-ichi Middle name Last name Iwasaki
Organization	Nihon University School of Medicine
Division name	Division of Hygiene, Department of Social Medicine
Zip code	179-8610
Address	30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	iwasaki.kenichi@nihon-u.ac.jp

Public contact
1st name of contact person	1st name Yojiro Middle name Last name Ogawa
Organization	Nihon University School of Medicine
Division name	Division of Hygiene, Department of Social Medicine
Zip code	173-8610
Address	30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Homepage URL
Email	ogawa.yojiro@nihon-u.ac.jp

Sponsor
Institute	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)

IRB Contact (For public release)
Organization	The institutional review board of Nihon University School of Medicine
Address	30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
Tel	03-3972-8111
Email	med.kenjim@nihon-u.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	2016 Year 03 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	13
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	2015 Year 06 Month 29 Day
Date of IRB	2017 Year 06 Month 20 Day
Anticipated trial start date	2017 Year 06 Month 21 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The part of the result in this study was published in Aerospace Medicine and Human Performance, 89; 787-791, 2018.

Management information
Registered date	2016 Year 03 Month 18 Day
Last modified on	2019 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024824