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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040670
Receipt No. 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

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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
Email 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
Email kfujim1@kaiyodai.ac.jp

Sponsor
Institute Tokyo University of Marine Science and Technology
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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