UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of yoga therapy on physical fitness in inpatients with psychiatric disorders: A single-blind randomized control trial.
Title of the study (Brief title)	The effect of yoga therapy on physical fitness in psychiatric disorders
Region	Japan

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

Objectives
Narrative objectives1	The present study investigates the effect of yoga therapy on components of physical fitness in inpatients with psychiatric disorders.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Postural instability: Clinical Stabilometric Platform (CSP) Anteflexion in sitting: Anteflexion measurement device Muscle strength: Strength testing with a portable dynamometer, Upper limb muscle endurance, lower limb muscle endurance
Key secondary outcomes	Positive and Negative Syndrome Scale for schizophrenia, Montgomery-Asberg Depression Rating Scale, and Young Mania Rating Scale for mood disorders, Mini Mental State Examination for dementia, Drug Induced Extrapyramidal Symptoms Scale, Global Assessment of Functioning for all disorders, Functional Assessment Staging for dementia, Targeted Inventory on Problems in Schizophrenia for schizophrenia, Modified Falls Efficacy Scales, International Physical Activity Questionnaire, EuroQol-5 dimensions classification system

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	The subjects were randomly assigned to either of the following two groups: yoga therapy group and treated-as-usual group. Subjects who were assigned to the yoga group received a weekly twenty or thirty -minutes yoga therapy in the hospital for a total of twenty-four sessions. Those sessions were provided as an adjunctive to routine ambulatory treatment. Each session consisted of gentle yoga stretches and simple movements in coordination with breathing (gentle movements of major muscle groups), asana (twisting poses and standing poses), deep relaxation, and breathing exercises.
Interventions/Control_2	In the control group, the subjects received a weekly regular day-care program (e.g. social skills and walking) for three-months.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(a) Diagnosed with psychiatric disorder (International Classification of Diseases, 10th edition) (b) In-patients treated at the Minamihanno Hospital (c) Ages 20 years or older (d) Able to communicate in Japanese
Key exclusion criteria	(a) Incapable of exercises
Target sample size	60

Research contact person
Name of lead principal investigator	Saeko Ikai
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	+81.3.3353.1211
Email	sako0609@gmail.com

Public contact
Name of contact person	Saeko Ikai
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	+81.3.3353.1211
Homepage URL
Email	sako0609@gmail.com

Sponsor
Institute	Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Inokashira Hospital Grants for Psychiatry Research
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 11 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 30 Day
Anticipated trial start date	2014 Year 11 Month 24 Day
Last follow-up date	2015 Year 12 Month 30 Day
Date of closure to data entry	2016 Year 04 Month 28 Day
Date trial data considered complete	2016 Year 12 Month 29 Day
Date analysis concluded	2017 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 17 Day
Last modified on	2017 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018167