UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028835
Receipt number 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 2021/02/26 09:48:53

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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 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 or person

Institute

Minami-hanno Hospital

Institute

Department

Personal name



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

Value
https://center6.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