Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001075673
Ethics application status
Approved
Date submitted
22/09/2014
Date registered
7/10/2014
Date last updated
7/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psycho-physiological outcomes of seated and supine yoga practices in yoga practitioners, non-yoga practitioners, and individuals with metabolic syndrome
Scientific title
An explorative study of metabolic responses to stress and yoga in yoga practitioners, non-yoga practitioners, and individuals with metabolic syndrome
Secondary ID [1] 285381 0
NIL
Universal Trial Number (UTN)
U1111-1162-0626
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 293115 0
Condition category
Condition code
Metabolic and Endocrine 293419 293419 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. All study participants (3 groups) underwent the similar single session experimental protocol which was of 60 minutes duration.
2. Experimental session involved nine equal duration phases ( 4 active and 5 resting) each of 5 minutes with one minute pause, to instruct the participants for next phase.
3. The active phases involved mental arithmetic stress test, alternate nostril yoga breathing, Kapalbhati Yoga breathing and yogic meditation and these phases were interspersed with the phases of quiet rest.
4. During the intervention period continuous oxygen consumption and Heart rate variability along with respiratory rate were continuously measured (for 60 minutes) using indirect calorimetery, electrocardiogram and respiratory belt.
5. As all the yoga interventions were the basic practices, hence the participants had the study explained on attending the laboratory. Each time a single participant was invited to attend the laboratory session.
6. All the experiential sessions were administered as well as explained and demonstrated to the participants prior to experimental session by the experimenter who was a yoga teacher also.
7. As the yoga practitioners were well versed with yoga interventions, hence the non-yoga practitioners and people with metabolic syndrome were given time to practice and get acquainted with the interventions till they performed them accurately.
8. All the experimental data were collected after participants provided their consent and signed the consent form.
Intervention code [1] 290323 0
Prevention
Intervention code [2] 290362 0
Lifestyle
Intervention code [3] 290363 0
Behaviour
Comparator / control treatment
This study involved three groups with same interventions as follows:
1. Regular Yoga practitioners
2. Non-yoga practitioners
3. People with metabolic syndrome
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293218 0
Oxygen consumption measured with canopy hood metabolic cart
Timepoint [1] 293218 0
60 minutes continuous
Primary outcome [2] 293244 0
Heart Rate variability measured through 3 lead electorcardiogarm
Timepoint [2] 293244 0
60 minutes continuous
Primary outcome [3] 293245 0
Respiratory rate measured through respiratory belt
Timepoint [3] 293245 0
60 minutes continuous
Secondary outcome [1] 310609 0
Psychological Measure
1.Profile of mood states: 5 theorised mood on 5 point scale ranging from 'not at all' to 'extremely'
Timepoint [1] 310609 0
Pre and immediate post intervention
Secondary outcome [2] 310785 0
Psychological Measure
2. Flow State: the measure of optimal psychological experience measured through 'Flow state scale' and 'Dispositional Flow State'; each scale including nine dimensions of Flow on 5 point scale ranging from 'never to always'
Timepoint [2] 310785 0
Pre and immediate post intervention

Eligibility
Key inclusion criteria
Group 1: Regular experienced yoga practitioners with minimum 6 months experience practicing yoga regularly for 90 minutes daily;
Group 2: Non-yoga practitioners (People who never practiced yoga previously but maintained active life);
Group 3: Metabolic syndrome patients as defined by 'International Diabetic Federation' and diagnosed by their general practitioners and treated with medication or prescribed lifestyle modification and have never practiced yoga
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnant woman and woman in their menstrual period were excluded to avoid the cyclic decrease in basal metabolic rate prior to ovulation;
2.People with any serious condition or condition requiring analgesic medication
3. People who were not able to perform the yogic interventions correctly

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not Applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/11/2011
Date of last participant enrolment
Anticipated
Actual
9/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6372 0
India
State/province [1] 6372 0
Uttrakhand

Funding & Sponsors
Funding source category [1] 289991 0
Self funded/Unfunded
Name [1] 289991 0
Country [1] 289991 0
Primary sponsor type
University
Name
RMIT University,
Address
RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia
Country
Australia
Secondary sponsor category [1] 288676 0
Charities/Societies/Foundations
Name [1] 288676 0
Patanjali Yoga Research Foundation
Address [1] 288676 0
Bahadrabad Road, Haridwar, Uttrakhand, India 249405
Country [1] 288676 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291699 0
RMIT ethics Committe
Ethics committee address [1] 291699 0
RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia
Ethics committee country [1] 291699 0
Australia
Date submitted for ethics approval [1] 291699 0
Approval date [1] 291699 0
11/07/2011
Ethics approval number [1] 291699 0
HREC 21/10
Ethics committee name [2] 291700 0
Patanjali Research Ethic Committe
Ethics committee address [2] 291700 0
Patanjali Yoga Research Foundation, Bahadarabad, Haridwar, Uttrakhand India 249405
Ethics committee country [2] 291700 0
India
Date submitted for ethics approval [2] 291700 0
Approval date [2] 291700 0
14/02/2014
Ethics approval number [2] 291700 0

Summary
Brief summary
To investigate the metabolic and cardio-autonomic changes during mental stress and yoga practices in regular yoga pratictioners, non-yoga pratcitioners and metabolic syndrome patients
Trial website
Trial related presentations / publications
Not Applicatble
Public notes
According to the policy and procedures of the Patanjali Research Foundation, the ethics approval from RMIT was sufficient to use the laboratory and collect data in India. Thus no separate approval was sought from Indian ethics committee. However the journal (BIOMED) in which this study has already been peer reviewed and now waiting for publication notified that the Indian Ethics approval is mandatory. Hence the ethic approval from Patanjlai Research Foundation was taken retrospectively.
Attachments [1] 199 199 0 0
/AnzctrAttachments/367136-Email from the editor of the Journal.docx

Contacts
Principal investigator
Name 51602 0
Mrs Anupama Tyagi
Address 51602 0
RMIT University, Plenty Road, Bundoora Campus, Bundoora, Victoria, Australia 3083
Country 51602 0
Australia
Phone 51602 0
+61 (0)400045690
Fax 51602 0
Email 51602 0
anupama.tyagi16@gmail.com
Contact person for public queries
Name 51603 0
Prof Marc Cohen
Address 51603 0
RMIT University, Plenty Road, Bundoora Campus, Bundoora, Victoria, Australia 3083
Country 51603 0
Australia
Phone 51603 0
+61 3 99257440
Fax 51603 0
+61 3 99257178
Email 51603 0
marc.cohen@rmit.edu.au
Contact person for scientific queries
Name 51604 0
Mrs Anupama Tyagi
Address 51604 0
RMIT University, Plenty Road, Bundoora Campus, Bundoora, Victoria, Australia 3083
Country 51604 0
Australia
Phone 51604 0
+61 (0)400045690
Fax 51604 0
Email 51604 0
anupama.tyagi16@gmail.com

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn explorative study of metabolic responses to mental stress and yoga practices in yoga practitioners, non-yoga practitioners and individuals with metabolic syndrome.2014https://dx.doi.org/10.1186/1472-6882-14-445
N.B. These documents automatically identified may not have been verified by the study sponsor.