UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011070
Receipt number R000012958
Scientific Title EFFECTS OF THE COMPREHENSIVE ART OF LIVING YOGIC BREATHING PROGRAMME ON THE PHYSIOLOGICAL AND PSYCHOLOGICAL WELL-BEING
Date of disclosure of the study information 2013/06/28
Last modified on 2013/06/28 22:15:42

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Basic information

Public title

EFFECTS OF THE COMPREHENSIVE ART OF LIVING YOGIC BREATHING PROGRAMME ON THE PHYSIOLOGICAL AND PSYCHOLOGICAL WELL-BEING

Acronym

EFFECTS OF THE COMPREHENSIVE ART OF LIVING YOGIC BREATHING PROGRAMME

Scientific Title

EFFECTS OF THE COMPREHENSIVE ART OF LIVING YOGIC BREATHING PROGRAMME ON THE PHYSIOLOGICAL AND PSYCHOLOGICAL WELL-BEING

Scientific Title:Acronym

EFFECTS OF THE COMPREHENSIVE ART OF LIVING YOGIC BREATHING PROGRAMME

Region

Europe


Condition

Condition

Health care

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

investigate effects of the breathing techniques on the well-being of healthy volonteers

Basic objectives2

Others

Basic objectives -Others

change in psychological parametersž
change in physiological parameters

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

significant influence of the AOL program on psychological wellness of the treated subjects

Key secondary outcomes

Physiological parameters show smaller changes that are additionally shielded by the large deviations for the most biomedical parameters.


Base

Study type


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

comprehensive 6-day program consisting of asanas (postures), pranayama (breathing exercise), Sudarshan Kriya (rhythmic breathing exercise), relaxation techniques, stress management, group processes and team work

Interventions/Control_2

no intervention

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

55 years-old >=

Gender

Male and Female

Key inclusion criteria

age from 20 to 55 years, BMI (body mass index) from 20-30, interest in yoga and relaxation exercise and willingness to participate in this three month study.

Key exclusion criteria

chronic diseases, serious health problems, drug and alcohol addiction, pregnancy and psychiatric disorders. practicing other other relaxation technique and/or intense physical activity during research study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name dr. sci. Sanja Kostrun

Organization

Art of Living Croatia

Division name

Research

Zip code


Address

Praunspergerova 7a, 10430 Samobor, Croatia

TEL

+385915648652

Email



Public contact

Name of contact person

1st name
Middle name
Last name dr. sci. Sanja Kostrun

Organization

Art of Living Croatia

Division name

Research

Zip code


Address

Vranovina 18, 10 000 Zagreb, Croatia

TEL

+385915648652

Homepage URL

http://www.artofliving.org

Email

sanja.kostrun@gmail.com


Sponsor or person

Institute

The Art of Living Croatia

Institute

Department

Personal name



Funding Source

Organization

BIAL Foundation

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Portugal


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

The Art of Living Croatia; MEDIRAD Policlinics; Department of Psychology, School of Medicine, School of Public Health,”Andrija Stampar", University of Zagreb; Department of Molecular Biosciences, University of Oslo


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 28 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 of research show significant influence of the SK&P program on psychological wellness of the treated subjects especially immediately after the course. Significant changes are measured in next psychological parameters: anxiety as a state, sealf-esteam, positive affect and negative affect, immediately after the course also in comparison within the control group. Three months after, only statistically significant change compared with the control group is for the negative affect. Changes in psychological parameters decrease with time and show need for regular practice of the SK&P program after ending workshop to keep positive changes initiated during the workshop.
Physiological parameters show smaller changes that are additionally shielded by the large deviations for the most biomedical parameters. They also change slower with time showing larger changes three months after the course.Only statistical changes in comparison between interventional and control group after three months of regular SK&P program are measured for the spirometric parameters (FEF50 and PEF)pointing to improved lung function.

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

2007 Year 06 Month 04 Day

Date of IRB


Anticipated trial start date

2008 Year 01 Month 10 Day

Last follow-up date

2008 Year 05 Month 23 Day

Date of closure to data entry

2008 Year 05 Month 30 Day

Date trial data considered complete

2008 Year 05 Month 31 Day

Date analysis concluded

2010 Year 12 Month 13 Day


Other

Other related information



Management information

Registered date

2013 Year 06 Month 28 Day

Last modified on

2013 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012958


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name