UMIN-CTR Clinical Trial

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
Email	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
Email	ookura.yoshi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050383