UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040670 |
|---|---|
| Receipt number | R000046415 |
| Scientific Title | Effects of differences in autonomic nervous system activity on diving reflex |
| Date of disclosure of the study information | 2020/06/08 |
| Last modified on | 2020/06/06 06:38:26 |
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Basic information
Public title
Effects of differences in autonomic nervous system activity on diving reflex
Acronym
Effects of differences in autonomic nervous system activity on diving reflex
Scientific Title
Effects of differences in autonomic nervous system activity on diving reflex
Scientific Title:Acronym
Effects of differences in autonomic nervous system activity on diving reflex
Region
| Japan |
Condition
Condition
diving reflex
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of autonomic nervous activity changed by low to moderate intensity exercise on the appearance of diving reflex
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate before and during face cooling
Key secondary outcomes
Blood pressure and Pulse wave velocity before and during face cooling
Autonomic nerve system activity before face cooling
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
low intensity exercise (applox.5min, once) and face cooling (1min, twice)
Interventions/Control_2
moderate intensity exercise (applox.15min, once) and face cooling (1min, twice)
Interventions/Control_3
no exercise and face cooling (1min, twice)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Student of Tokyo University of marine science and technology and age of over 20 years of adult
2.Participants is fully informed about the study and has singed the informed consent form
3.Participant who can carry out study and manage their own physical condition in the schedule presented by researcher
4.Participant who sign up for Personal Accident Insurance for Students Pursuing Education and Research or equivalent insurance
5.Resting heart rate is 50 to 100bpm immediately before measurement
6.Resting blood pressure is less than 140/80 immediately before measurement
7.Participant has enough sleep the day before measurement
8.At least 2 hours have passed from eating
9.With no drinking
10.With no taking caffeine or at least 2 hours has passed from taking
Key exclusion criteria
1.Person who satisfy the inclusion criteria above
2.Person who is given class credits by the research supervisor during reserch period
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | FUJIMOTO |
Organization
Tokyo University of Marine Science and Technology
Division name
Department of Marine Policy and Culture
Zip code
108-8477
Address
4-5-7, Kownan, Minato-ku
TEL
03-5463-0638
kfujim1@kaiyodai.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | FUJIMOTO |
Organization
Tokyo University of Marine Science and Technology
Division name
Department of Marine Policy and Culture
Zip code
108-8477
Address
4-5-7, Kownan, Minato-ku
TEL
03-5463-0638
Homepage URL
kfujim1@kaiyodai.ac.jp
Sponsor or person
Institute
Tokyo University of Marine Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Tokyo University of Marine Science and Technology Research Ethics Committee
Address
4-5-7, Kownan, Minato-ku
Tel
03-5463-4197
ke-ken@o.kaiyodai.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
| 2020 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
| 2019 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 06 | Day |
Last modified on
| 2020 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046415
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
