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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
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Scientific title
Evaluation of a 12 week Yoga Intervention on Negative Affective States, Cardiovascular and Cognitive Function in Post-Cardiac Rehabilitation Patients
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Secondary ID [1]
279896
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
285795
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Anxiety
285796
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Stress
285797
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Cardiovascular disease
285798
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Condition category
Condition code
Mental Health
285973
285973
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0
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Depression
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Mental Health
285974
285974
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0
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Anxiety
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Cardiovascular
285975
285975
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
284217
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Lifestyle
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Intervention code [2]
284567
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Prevention
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Intervention code [3]
284574
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Rehabilitation
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Comparator / control treatment
No intervention control group
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Control group
Active
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Outcomes
Primary outcome [1]
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Relative difference in all subscales and overall score of the Depression Anxiety Stress Scale (DASS)
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Assessment method [1]
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Timepoint [1]
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Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
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Secondary outcome [1]
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Relative difference in carotid intima media thickness values assessed using high resolution B-mode carotid sonography.
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Assessment method [1]
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Timepoint [1]
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Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
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Secondary outcome [2]
295950
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Relative difference in heart rate variability assessed with an ECG linked to a SphygmoCor system.
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Assessment method [2]
295950
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Timepoint [2]
295950
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Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
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Secondary outcome [3]
295951
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Relative difference in pulse wave velocity conducted with ECG linked carotid-femoral tonometric assessment using the SphygmoCor system.
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Assessment method [3]
295951
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Timepoint [3]
295951
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Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
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Secondary outcome [4]
295952
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Relative difference in c-reactive protein assessed with serum assay from blood samples collected at a designated pathology center
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Assessment method [4]
295952
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Timepoint [4]
295952
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Timepoints at baseline (week 0) and post-treatment (week 12)
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Secondary outcome [5]
295953
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Relative difference in quality of life measured with short form 36 version 2
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Assessment method [5]
295953
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Timepoint [5]
295953
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Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
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Secondary outcome [6]
295954
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Relative difference in glucose and lipid profiles assessed with serum assay from blood samples collected at a designated pathology center
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Assessment method [6]
295954
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Timepoint [6]
295954
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Timepoints at baseline (week 0) and post-treatment (week 12)
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Secondary outcome [7]
295955
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Relative difference in cognition measured by the Computerised Mental Performance Assessment System
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Assessment method [7]
295955
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Timepoint [7]
295955
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Timepoints at baseline (week 0), mid-treatment (week 6), post-treatment (week 12) and follow up (week 16)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/04/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
5156
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2076
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Recruitment postcode(s) [2]
5157
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2560
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Western Sydney
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Address [1]
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University of Western Sydney
Locked Bag 1797
Penrith
NSW
2751
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Country [1]
284982
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Australia
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Primary sponsor type
University
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Name
University of Western Sydney
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Address
University of Western Sydney
Locked Bag 1797
Penrith
NSW
2751
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
283846
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Country [1]
283846
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
286986
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University of Western Sydney
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Ethics committee address [1]
286986
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Locked Bag 1797 Penrith NSW 2751
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Ethics committee country [1]
286986
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Australia
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Date submitted for ethics approval [1]
286986
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04/11/2011
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Approval date [1]
286986
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23/01/2012
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Ethics approval number [1]
286986
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H9402
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Ethics committee name [2]
286987
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Sydney Adventist Hospital
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Ethics committee address [2]
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185 Fox Valley Road Wahroonga NSW 2076
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Ethics committee country [2]
286987
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Australia
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Date submitted for ethics approval [2]
286987
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04/11/2011
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Approval date [2]
286987
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13/02/2012
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Ethics approval number [2]
286987
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2011-040
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Summary
Brief summary
Cardiac rehabilitation programs have been proven to improve a range of cardiovascular and psychosocial risk factors in cardiac patients; however, the decline in sustained exercise in post-cardiac rehabilitation patients suggests the need for interventions to both maintain physical activity as well as offsetting the risks of future cardiac incidents. Evidence supports the use of yoga highlighting strong adherence rates to yoga exercise and significant improvements in stress, depression, anxiety and physical aspects of health in a range of healthy and clinical populations. This current study aims to determine whether a standardised yoga intervention will improve stress, anxiety, depression, cardiovascular function and cognitive function in post-cardiac rehabilitation patients. This is a 16 week randomised control trial using a range of psychological and physical tests to determine the effects of a 12 week yoga intervention and whether beneficial effects persist 4 week after the end of the intervention.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Alan Yeung
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Address
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Centre for Complementary Medicine Research (CompleMED)
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
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Country
16993
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Australia
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Phone
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+61 2 4620 3278
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Fax
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Email
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alan.yeung@uws.edu.au
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Contact person for scientific queries
Name
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Alan Yeung
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Address
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Centre for Complementary Medicine Research (CompleMED)
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
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Country
7921
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Australia
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Phone
7921
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+61 2 4620 3278
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Fax
7921
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Email
7921
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alan.yeung@uws.edu.au
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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
Randomised controlled trial of a 12 week yoga intervention on negative affective states, cardiovascular and cognitive function in post-cardiac rehabilitation patients.
2014
https://dx.doi.org/10.1186/1472-6882-14-411
N.B. These documents automatically identified may not have been verified by the study sponsor.
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