UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036071 |
|---|---|
| Receipt number | 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 | 2020/05/19 09:34:53 |
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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
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Watanabe |
Organization
Kagoshima City Hospital
Division name
Department of Rehabilitation
Zip code
890-8760
Address
37-1 Uearata-Cho,Kagoshima-City,Kagoshima 890-8760,Japan
TEL
099-230-7000
rptnabe3@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Watanabe |
Organization
Kagoshima City Hospital
Division name
Department of Rehabilitation
Zip code
890-8760
Address
37-1 Uearata-Cho,Kagoshima-City,Kagoshima 890-8760,Japan
TEL
099-230-7000
Homepage URL
rptnabe3@gmail.com
Sponsor or person
Institute
Kagoshima City Hospital
Institute
Department
Personal name
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
Kagoshima City Hospital
Address
37-1 Uearata-Cho,Kagoshima-City,Kagoshima 890-8760,Japan
Tel
099-230-7000
kch-kenkyu@kch.kagoshima.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
| 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
20
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 | 01 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
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
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041092
| Research Plan | |
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| Registered date | File name |
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