UMIN-CTR Clinical Trial

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 Saeko Middle name Last name Ikai
Organization	Minami-hanno Hospital
Division name	Medical office
Zip code	1510051
Address	415, yaoroshi, hannno-shi, Saitama, Japan
TEL	81-42-972-7111
Email	sako0609@gmail.com

Public contact
Name of contact person	1st name Saeko Middle name Last name Ikai
Organization	Minami-hanno Hospital
Division name	Medical office
Zip code	3570042
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	Minami-hanno Hospital
Address	415, yaoroshi, hannno-shi, Saitama, Japan
Tel	81-42-972-7111
Email	sako0609@yahoo.co.jp

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	https://pubmed.ncbi.nlm.nih.gov/33316106/
Publication of results	Unpublished

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/33316106/
Number of participants that the trial has enrolled	31
Results	31 patients participated in this study. Participants in the yoga group (n=11) and the Pilates group (n=10) demonstrated a significantly greater improvement in the range of trunk motion than those assigned to the group therapy (P<0.001). In addition to this, the yoga group showed a decreased level of SAA activity in comparison to the Pilates group (P=0.046). However, these improvements were not sustained at the follow-up.
Results date posted	2021 Year 02 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Design and participants: An open-label randomized controlled trial in which in/outpatients diagnosed with any psychiatric disorder according to the International Classification of Diseases, the 10th edition were randomly assigned to yoga, Pilates, or group therapy between August 2017 and June 2018. Setting: Minami-Hanno Hospital, Saitama, Japan.
Participant flow	Interventions: Participants in each group received a 30-minute session of Hatha yoga, floor-based Pilates, or group therapy focusing on healthy lifestyle with tips on fall prevention (1:1:1) in addition to their ongoing psychopharmacological treatments.
Adverse events	None
Outcome measures	Outcome measures: We measured postural stability using the clinical stabilometric platform and salivary alpha-amylase (SAA) activity before and after each session and at the one-week follow-up.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 26 Day
Date of IRB	2017 Year 07 Month 30 Day
Anticipated trial start date	2017 Year 08 Month 28 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 02 Month 29 Day
Date analysis concluded	2020 Year 02 Month 29 Day

Other
Other related information

Management information
Registered date	2017 Year 08 Month 25 Day
Last modified on	2021 Year 02 Month 26 Day

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