UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044281 |
|---|---|
| Receipt number | R000050383 |
| Scientific Title | Effects of Yoga Exercise on Psychological Stress and Autonomic Nervous System Function |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/05/21 14:58:21 |
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Basic information
Public title
Effects of Yoga Exercise on Psychological Stress and Autonomic Nervous System Function
Acronym
Effects of Yoga Exercise on Psychological Stress and Autonomic Nervous System Function
Scientific Title
Effects of Yoga Exercise on Psychological Stress and Autonomic Nervous System Function
Scientific Title:Acronym
Effects of Yoga Exercise on Psychological Stress and Autonomic Nervous System Function
Region
| Japan |
Condition
Condition
No(Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of yoga on the autonomic nervous system and psychological stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the autonomic function index (ccvHF) before and after exercise.
Key secondary outcomes
Changes in autonomic function indices (heart rate, CVRR, ccVL/H) before and after exercise.
Changes in the psychological stress response scale (SRS-18) before and after exercise.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Yoga exercise
Interventions/Control_2
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy university students who have not had regular visits to hospital or treatment
Key exclusion criteria
Unsuitable for exercise training.
Based on the Anderson-Doi criteria and the criteria for discontinuation of exercise training in the Guidelines for the Diagnosis and Treatment of Cardiovascular Disease (2011 Joint Study Group Report).
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ookura |
Organization
Tokushima University Hospital
Division name
Department of General Medicine and Primary Care
Zip code
7708503
Address
50 Kuramoto-cho 2, Tokushima, Japan
TEL
088-633-9656
ookura.yoshi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ookura |
Organization
Tokushima University Hospital
Division name
Department of General Medicine and Primary Care
Zip code
7708503
Address
50 Kuramoto-cho 2, Tokushima, Japan
TEL
088-633-9656
Homepage URL
ookura.yoshi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima 770-8503, Japan
Tel
088-633-9294
awachiken@tokushima-u.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
| 2021 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2021 | Year | 05 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050383
