UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007868 |
|---|---|
| Receipt number | R000009270 |
| Scientific Title | Change of Stress Susceptibility and the Stress-related Biomarker by Yoga Training |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2012/05/01 11:38:57 |
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Basic information
Public title
Change of Stress Susceptibility
and the Stress-related Biomarker by Yoga Training
Acronym
Effect of 12-weeks of Yoga Training on Psychosomatic Symptoms and the Stress-related Biomarker
Scientific Title
Change of Stress Susceptibility
and the Stress-related Biomarker by Yoga Training
Scientific Title:Acronym
Effect of 12-weeks of Yoga Training on Psychosomatic Symptoms and the Stress-related Biomarker
Region
| Japan |
Condition
Condition
Healthy females
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examin the beneficial effects of 12-weeks of yoga training on somatization, psychological symptoms, and stress-related biomarkers simultaneously
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Somatization and psychological symptoms after 12-weeks of yoga training (score of the Profile of Mood State (POMS) and the Symptom Checklist-90-Revised (SCL-90-R))
Urinary stress-related biomarkers after 12-weeks of yoga training (8-hydroxydeoxyguanosine (8-OHdG), biopyrrin, and cortisol levels)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Yoga classes are conducted one day a week for about one hour each session for 12 weeks. The participants are required to attend at least 10 of the 12 weekly yoga sessions and to practice at home at least twice a week for over 30 minutes each session.
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy females who had no experience with yoga
Key exclusion criteria
1) Taking medication including supplements in the month prior to the experiment
2) Having an illness
3) Having a past history of significant physical or mental illness
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazufumi Yoshihara |
Organization
National Institute for Physiological Sciences
Division name
Division of Cerebral Integration
Zip code
Address
38 Myodaiji-Nishigonaka, Okazaki, Aichi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute for Physiological Sciences
Division name
Division of Cerebral Integration
Zip code
Address
38 Myodaiji-Nishigonaka, Okazaki, Aichi, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Psychosomatic Medicine, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Life Foundation of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Yoga Therapy Society
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 05 | 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
Completed
Date of protocol fixation
| 2007 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | 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
| 2012 | Year | 05 | Month | 01 | Day |
Last modified on
| 2012 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009270
