ANZCTR - Registration

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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]

NIL

Universal Trial Number (UTN)

U1111-1162-0626

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Metabolic syndrome

Condition category

Condition code

Metabolic and Endocrine

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Oxygen consumption measured with canopy hood metabolic cart

Timepoint [1]

60 minutes continuous

Primary outcome [2]

Heart Rate variability measured through 3 lead electorcardiogarm

Timepoint [2]

60 minutes continuous

Primary outcome [3]

Respiratory rate measured through respiratory belt

Timepoint [3]

60 minutes continuous

Secondary outcome [1]

Psychological Measure
1.Profile of mood states: 5 theorised mood on 5 point scale ranging from 'not at all' to 'extremely'

Timepoint [1]

Pre and immediate post intervention

Secondary outcome [2]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

India

State/province [1]

Uttrakhand

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

RMIT University,

Address

RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Patanjali Yoga Research Foundation

Address [1]

Bahadrabad Road, Haridwar, Uttrakhand, India 249405

Country [1]

India

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RMIT ethics Committe

Ethics committee address [1]

RMIT University, PO Box 71, Bundoora, Victoria 3083, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/07/2011

Ethics approval number [1]

HREC 21/10

Ethics committee name [2]

Patanjali Research Ethic Committe

Ethics committee address [2]

Patanjali Yoga Research Foundation, Bahadarabad, Haridwar, Uttrakhand India 249405

Ethics committee country [2]

India

Date submitted for ethics approval [2]

Approval date [2]

14/02/2014

Ethics approval number [2]

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]

/AnzctrAttachments/367136-Email from the editor of the Journal.docx

Contacts

Principal investigator

Name

Mrs Anupama Tyagi

Address

RMIT University, Plenty Road, Bundoora Campus, Bundoora, Victoria, Australia 3083

Country

Australia

Phone

+61 (0)400045690

Fax

[email protected]

Contact person for public queries

Name

Marc Cohen

Address

RMIT University, Plenty Road, Bundoora Campus, Bundoora, Victoria, Australia 3083

Country

Australia

Phone

+61 3 99257440

Fax

+61 3 99257178

[email protected]

Contact person for scientific queries

Name

Anupama Tyagi

Address

RMIT University, Plenty Road, Bundoora Campus, Bundoora, Victoria, Australia 3083

Country

Australia

Phone

+61 (0)400045690

Fax

[email protected]

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	An explorative study of metabolic responses to mental stress and yoga practices in yoga practitioners, non-yoga practitioners and individuals with metabolic syndrome.	2014	https://dx.doi.org/10.1186/1472-6882-14-445

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically