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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009305
Receipt No. R000010928
Scientific Title Effects of Yoga Therapy on Resielence,Biological marker in Schizophrenia: A Single-Blind Randomized Controlled Trial
Date of disclosure of the study information 2012/11/11
Last modified on 2014/11/04

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Basic information
Public title Effects of Yoga Therapy on Resielence,Biological marker in Schizophrenia: A Single-Blind Randomized Controlled Trial
Acronym Effects of Yoga Therapy on Resistant in Schizophrenia
Scientific Title Effects of Yoga Therapy on Resielence,Biological marker in Schizophrenia: A Single-Blind Randomized Controlled Trial
Scientific Title:Acronym Effects of Yoga Therapy on Resistant in Schizophrenia
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Single-blind randomized study to verify the effect of yoga therapy to resielence among out-patients with schizophrenia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Resilience Scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 Individuals assigned to yoga therapy received eight sessions of 60 minutes, once a week.
Interventions/Control_2 Control.
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
18 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Our criteria were (1) outpatient with schizophrenia confirmed with the ICD-10 (_) over 18 years of age, (2) patients of the regular day-care programs in Yamanashi Prefectural Kita Hospital, (3) enable to informed consent.
Key exclusion criteria None
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikai Saeko
Organization Yamanashi Prefectural Kita Hospital
Division name Medical office
Zip code
Address 13-14, kamijyouminamiwari, asahimati, nirasakisi, yamanashi
TEL 0551221621
Email sako0609@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name SAEKO IKAI
Organization Yamanashi Prefectural Kita Hospital
Division name Medical office
Zip code
Address 13-14, kamijyouminamiwari, asahimati, nirasakisi, yamanashi
TEL 0551221621
Homepage URL
Email sako0609@gmail.com

Sponsor
Institute Yamanashi Prefectural Kita Hospital
Institute
Department

Funding Source
Organization None
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
2012 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 19 Day
Last follow-up date
2013 Year 04 Month 30 Day
Date of closure to data entry
2013 Year 08 Month 30 Day
Date trial data considered complete
2013 Year 09 Month 30 Day
Date analysis concluded
2014 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 10 Day
Last modified on
2014 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010928

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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