UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021528 |
|---|---|
| Receipt number | R000024824 |
| Scientific Title | The effects of widespread changes of gravity on circulation |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2019/03/25 15:22:01 |
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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
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
iwasaki.kenichi@nihon-u.ac.jp
Public contact
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
ogawa.yojiro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024824
