UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015711 |
|---|---|
| Receipt number | R000018167 |
| Scientific Title | The effect of yoga therapy on physical fitness in inpatients with psychiatric disorders: A single-blind randomized control trial. |
| Date of disclosure of the study information | 2014/11/17 |
| Last modified on | 2017/07/27 22:31:25 |
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Basic information
Public title
The effect of yoga therapy on physical fitness in inpatients with psychiatric disorders: A single-blind randomized control trial.
Acronym
The effect of yoga therapy on physical fitness in psychiatric disorders
Scientific Title
The effect of yoga therapy on physical fitness in inpatients with psychiatric disorders: A single-blind randomized control trial.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Saeko Ikai |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
+81.3.3353.1211
sako0609@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saeko Ikai |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
+81.3.3353.1211
Homepage URL
sako0609@gmail.com
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department
Personal name
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)
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
| 2014 | Year | 11 | Month | 17 | 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
| 2014 | Year | 10 | Month | 30 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018167
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