Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000358842
Ethics application status
Approved
Date submitted
27/03/2012
Date registered
28/03/2012
Date last updated
28/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a 12 week yoga program on negative moods in post- cardiac rehabilitation patients
Scientific title
Evaluation of a 12 week Yoga Intervention on Negative Affective States, Cardiovascular and Cognitive Function in Post-Cardiac Rehabilitation Patients
Secondary ID [1] 279896 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 285795 0
Anxiety 285796 0
Stress 285797 0
Cardiovascular disease 285798 0
Condition category
Condition code
Mental Health 285973 285973 0 0
Depression
Mental Health 285974 285974 0 0
Anxiety
Cardiovascular 285975 285975 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will be a 12 week standardised yoga program consisting of 2 instructor lead class sessions and 1 self practice home session every week.

This yoga program will be a customised hatha yoga program incorporating postures (balance, stretching and core strenght), meditation and breathing exercises.

Each instructor lead session will be approximately 1 hour in duration and participants will be asked to practice for 1 hour at home once a week.
Intervention code [1] 284217 0
Lifestyle
Intervention code [2] 284567 0
Prevention
Intervention code [3] 284574 0
Rehabilitation
Comparator / control treatment
No intervention control group
Control group
Active

Outcomes
Primary outcome [1] 286473 0
Relative difference in all subscales and overall score of the Depression Anxiety Stress Scale (DASS)
Timepoint [1] 286473 0
Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
Secondary outcome [1] 295949 0
Relative difference in carotid intima media thickness values assessed using high resolution B-mode carotid sonography.
Timepoint [1] 295949 0
Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
Secondary outcome [2] 295950 0
Relative difference in heart rate variability assessed with an ECG linked to a SphygmoCor system.
Timepoint [2] 295950 0
Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
Secondary outcome [3] 295951 0
Relative difference in pulse wave velocity conducted with ECG linked carotid-femoral tonometric assessment using the SphygmoCor system.
Timepoint [3] 295951 0
Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
Secondary outcome [4] 295952 0
Relative difference in c-reactive protein assessed with serum assay from blood samples collected at a designated pathology center
Timepoint [4] 295952 0
Timepoints at baseline (week 0) and post-treatment (week 12)
Secondary outcome [5] 295953 0
Relative difference in quality of life measured with short form 36 version 2
Timepoint [5] 295953 0
Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
Secondary outcome [6] 295954 0
Relative difference in glucose and lipid profiles assessed with serum assay from blood samples collected at a designated pathology center
Timepoint [6] 295954 0
Timepoints at baseline (week 0) and post-treatment (week 12)
Secondary outcome [7] 295955 0
Relative difference in cognition measured by the Computerised Mental Performance Assessment System
Timepoint [7] 295955 0
Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)

Eligibility
Key inclusion criteria
-Patients having had revascularisation procedures and completion of an approved phase 2 cardiac rehabilitation program within the past 9 months
-over 18 years of age
-ability to give informed consent
-ability to perform prescribed yoga movements
-ability to complete the 12 week yoga intervention
-ability to speak and read English fluently
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-pregnancy
-severe cognitive deficits (MMSE< 21)
-previous or current psychological disorders not associated with depression or anxiety
-end stage congestive heart failure
-permanent bed-bound status
-unstable abdominal, thoracic or cerebral aneurysm
-acute myocarditis, pericarditis, pulmonary embolus or pulmonary infarction
-participation in a yoga program prior to or during the study
-participation in a clinical trial for an experimental drug within the last 30 days before the study
-consumption of caffeine 4 hours prior or alcohol 24 hours prior to testing sessions

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



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5156 0
2076
Recruitment postcode(s) [2] 5157 0
2560

Funding & Sponsors
Funding source category [1] 284982 0
University
Name [1] 284982 0
University of Western Sydney
Country [1] 284982 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
University of Western Sydney
Locked Bag 1797
Penrith
NSW
2751
Country
Australia
Secondary sponsor category [1] 283846 0
None
Name [1] 283846 0
Address [1] 283846 0
Country [1] 283846 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286986 0
University of Western Sydney
Ethics committee address [1] 286986 0
Ethics committee country [1] 286986 0
Australia
Date submitted for ethics approval [1] 286986 0
04/11/2011
Approval date [1] 286986 0
23/01/2012
Ethics approval number [1] 286986 0
H9402
Ethics committee name [2] 286987 0
Sydney Adventist Hospital
Ethics committee address [2] 286987 0
Ethics committee country [2] 286987 0
Australia
Date submitted for ethics approval [2] 286987 0
04/11/2011
Approval date [2] 286987 0
13/02/2012
Ethics approval number [2] 286987 0
2011-040

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33746 0
Address 33746 0
Country 33746 0
Phone 33746 0
Fax 33746 0
Email 33746 0
Contact person for public queries
Name 16993 0
Alan Yeung
Address 16993 0
Centre for Complementary Medicine Research (CompleMED)
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country 16993 0
Australia
Phone 16993 0
+61 2 4620 3278
Fax 16993 0
Email 16993 0
[email protected]
Contact person for scientific queries
Name 7921 0
Alan Yeung
Address 7921 0
Centre for Complementary Medicine Research (CompleMED)
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country 7921 0
Australia
Phone 7921 0
+61 2 4620 3278
Fax 7921 0
Email 7921 0
[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
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial of a 12 week yoga intervention on negative affective states, cardiovascular and cognitive function in post-cardiac rehabilitation patients.2014https://dx.doi.org/10.1186/1472-6882-14-411
N.B. These documents automatically identified may not have been verified by the study sponsor.