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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036071
Receipt No. R000041092
Scientific Title Effect of yoga on the autonomic nervous system in a healthy person.
Date of disclosure of the study information 2019/03/04
Last modified on 2019/03/04

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Basic information
Public title Effect of yoga on the autonomic nervous system in a healthy person.
Acronym Effect of yoga on the autonomic nervous system in a healthy person.
Scientific Title Effect of yoga on the autonomic nervous system in a healthy person.
Scientific Title:Acronym Effect of yoga on the autonomic nervous system in a healthy person.
Region
Japan

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

Objectives
Narrative objectives1 Examine whether enhance parasympathetic activity by suppressing acceleration of sympathetic nerve activity by carrying out yoga which can be carried out by sitting on a chair against a healthy person.
Automatic nerve measuring device
Inspection item:CVRR,HF,LF/HF,ccvHF,ccvL/H etc
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Autonomic function
Key secondary outcomes Heart rate
Blood pressure

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Sitting on a chair,three kinds of yoga of asana,pranayama and meditation on were carried out of a total of about 20 minutes.
Analysis of electrocardiogram at resting position,standing upright,standing position and sitting before and after yoga practice.
Measure electrocardiogram for 6 minutes before and after yoga.
Coefficient of Variation on R-R interval(CVRR)is analyzed by RR spectrum and the parasympathetic activity index(HF) and the sympathetic activity index(LF/HF),which are autonomic indexes, are measured.
Interventions/Control_2 Sitting on a chair,watch DVD about 20 minutes.
Analysis of electrocardiogram at resting position,standing upright,standing position and sitting before and after watch DVD.
Measure electrocardiogram for 6 minutes before and after yoga.
Coefficient of Variation on R-R interval(CVRR)is analyzed by RR spectrum and the parasympathetic activity index(HF) and the sympathetic activity index(LF/HF),which are autonomic indexes, are measured.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Healthy person.
There is not medical history of life-style diseases or heart diseases.
Key exclusion criteria Regularly take medication.
Regularly visit.
History of heart disease.
Lifestyle diseases (Hypertension, hyperlipidemia, diabetes).
Those who can not obtain written consent from study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Watanabe
Organization Kagoshima City Hospital
Division name Department of Rehabilitation
Zip code
Address 37-1 Uearata-Cho,Kagoshima-City,Kagoshima 890-8760,Japan
TEL 099-230-7000
Email rptnabe3@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Watanabe
Organization Kagoshima City Hospital
Division name Department of Rehabilitation
Zip code
Address 37-1 Uearata-Cho,Kagoshima-City,Kagoshima 890-8760,Japan
TEL 099-230-7000
Homepage URL
Email rptnabe3@gmail.com

Sponsor
Institute Kagoshima City Hospital
Institute
Department

Funding Source
Organization Kagoshima University
Graduate school of Medical and Dental Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 03 Month 04 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
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 No longer recruiting
Date of protocol fixation
2019 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 04 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041092

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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