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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028835
Receipt No. R000032906
Scientific Title The instant effects of yoga therapy, pilates, and life guidance on frail in patients with psychiatric disorders: An open label comparison trial.
Date of disclosure of the study information 2017/08/25
Last modified on 2019/02/25

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Basic information
Public title The instant effects of yoga therapy, pilates, and life guidance on frail in patients with psychiatric disorders: An open label comparison trial.
Acronym Frail and Yoga therapy
Scientific Title The instant effects of yoga therapy, pilates, and life guidance on frail in patients with psychiatric disorders: An open label comparison trial.
Scientific Title:Acronym Frail and Yoga therapy
Region
Japan

Condition
Condition Psychiatric disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study aims to investigate the instant effects of yoga therapy, pilates, life guidance on frail in patients with psychiatric disorders.
Basic objectives2 Others
Basic objectives -Others The present study aims to evaluate the efficacy and safety of yoga therapy, pilates, life guidance inpatient with risks of frail.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Participants will be assessed these outcomes before and after the intervention, and 1 week later of the intervention.
Postural sway: Clinical Stabilometric Platform (CSP).
Flexibility: Anteflexion measurement device.
Muscle strength: Hand grip.
Key secondary outcomes Salivary Oxytocin: Salivary Oxytocin EIA Kit
Stress marker: Salivary Amylase
Happiness: Subjective Happiness Scale
Autoimmune system: Max & Pulse
Fatigue: Visual Analogue Scale
Psycho-pathology: Positive and Negative Syndrome Scale (PANSS) for schizophrenia spectrum disorders
Montgomery-Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) for mood disorders
Cognitive function: Mini Mental State Examination (MMSE) for dementia, Frontal Assessment Battery (FAB)
EPS: Drug Induced Extrapyramidal Symptoms Scale (DIEPSS)
Social functioning: Global Assessment of Functioning (GAF)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Yoga therapy : 20-30 minutes/day, Each session consisted of yoga stretches and simple movements in coordination with breathing (gentle movements of major muscle groups), and asana.
Interventions/Control_2 Pilates : 20-30 minutes/day, Each session consisted of simple pilates movements in coordination with breathing.
Interventions/Control_3 Life guidance : 20-30 minutes/day, educational sessions about exercise habits, eating habits, and prevention of falls.
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Diagnosed with psychiatric disorder (International Classification of Disease, 10th edition)
2 Inpatients or outpatients treated at the Minami Hanno Hospital
3 Capable of informed consent
4 Stable regime for 8 weeks
Key exclusion criteria Incapable of exercise
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Saeko Ikai
Organization Minami-hanno Hospital
Division name Medical office
Zip code
Address 415, yaoroshi, hannno-shi, Saitama, Japan
TEL 81-42-972-7111
Email sako0609@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Saeko Ikai
Organization Minami-hanno Hospital
Division name Medical office
Zip code
Address 415, yaoroshi, hannno-shi, Saitama, Japan
TEL 81-42-972-7111
Homepage URL
Email sako0609@gmail.com

Sponsor
Institute Minami-hanno Hospital
Institute
Department

Funding Source
Organization Minami-hanno Hospital
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
2017 Year 08 Month 25 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 28 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 08 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 25 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032906

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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