UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019915 |
|---|---|
| Receipt number | R000022944 |
| Scientific Title | Effect of normobaric hypoxic exercise on dynamic cerebral autoregulation. |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2018/10/18 17:39:58 |
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Basic information
Public title
Effect of normobaric hypoxic exercise on dynamic cerebral autoregulation.
Acronym
Effect of normobaric hypoxic exercise on dynamic cerebral autoregulation.
Scientific Title
Effect of normobaric hypoxic exercise on dynamic cerebral autoregulation.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Iwasaki/Ryo Yanagida |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
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 | |
| Middle name | |
| Last name | Ryo Yanagida |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
Address
30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
yanagida.ryo@nihon-u.ac.jp
Sponsor or person
Institute
Division of Hygiene, Department of Social Medicine, 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
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
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
| 2013 | Year | 06 | Month | 18 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022944
