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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
