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Trial registered on ANZCTR


Registration number
ACTRN12611000536965
Ethics application status
Approved
Date submitted
24/05/2011
Date registered
24/05/2011
Date last updated
14/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of an office worksite-based yoga program on heart rate variability: A randomised controlled trial
Scientific title
A randomised controlled trial of office-worksite based hatha yoga on heart rate variability in apparently healthy workers
Secondary ID [1] 262246 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 267937 0
Condition category
Condition code
Cardiovascular 268083 268083 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hatha Yoga (postures and meditation). Participants randomised to the experimental condition will engage in a 10-week yoga program delivered at their place of work (UWS Campbelltown Campus) three days per week for one hour per session. Sessions will be group-based and will be led by an experienced yoga instructor from Yoga Synergy Pty Ltd (Sydney, Australia). The program will involve teaching beginner students safely and progressively over 10 weeks, a yoga sequence that incorporates asanas (poses and postures), vinyasa (exercises), pranayama (breathing control) and meditation. The sequence design will be aimed at developing strength, flexibility, cardiovascular fitness, increasing energy and the ability to deal with stress. All postures have a simple and a more challenging version so participants will be able to choose the level of difficulty that is appropriate to them on any given day.
Intervention code [1] 266635 0
Prevention
Intervention code [2] 266643 0
Lifestyle
Comparator / control treatment
No intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266821 0
Heart Rate Variability: Evaluation of HRV will be completed in a quiet and temperature controlled room in accordance with procedures developed by the Task Force for Pacing and Electrophysiology. Participants will be advised to abstain from caffeinated food and beverages on the day of their assessments; repeat assessments will be completed at the precisely the same time of day. After 15 minutes of supine rest with a regular and calm breathing pattern, a continuous 10-minute ECG recording will be collected using an applanation tonometer interface with HRV software (Sphygmocor, AtCor Medical Pty, Sydney, Australia). From the electrocardiographic recording, the following statistical and geometric time domain indices will be calculated from RR intervals: standard deviation of the NN intervals, and the root mean square of the difference of successive R-R intervals, triangular index and the HRV index. Frequency domain variables including total, high frequency (HF) and low frequency (LF) power and LF:HF ratio will be derived from spectral analysis of successive R-R intervals. This technique separates the heart rate spectrum into its frequency components and provides quantitative estimates of sympathetic and vagal influences on the heart.
Timepoint [1] 266821 0
Baseline, Week 11 and 6-months
Secondary outcome [1] 276450 0
Quality of Life: The Medical Outcomes Trust Short-form 36 Health Status Questionnaire (SF36) Version 1.0 is a generic health status measure that assesses eight domains of quality of life. This instrument demonstrates a high degree of internal consistency and construct validity, has been designed for self-administration, and has been shown to be sensitive enough to detect changes over time in response to a yoga intervention. The survey will be self-administered in a quiet office at each timepoint.
Timepoint [1] 276450 0
Baseline, Week 11 and 6-months
Secondary outcome [2] 276457 0
Job satisfaction and general work-related stress: will be evaluated via global Job Descriptive Index and Job in General Scale, respectively. Both scales have been validated for use in the general population, including office workers. The survey will be self-administered in a quiet office at each timepoint.
Timepoint [2] 276457 0
Baseline, Week 11 and 6-months
Secondary outcome [3] 276458 0
State and Trait Anxiety: The State-Trait Anxiety Inventory is a widely used and validated inventory that consists of two, twenty-item self-report scales for measuring state anxiety and trait anxiety as distinct and clearly defined psychological constructs in adults. The survey will be self-administered in a quiet office at each timepoint.
Timepoint [3] 276458 0
Baseline, Week 11 and 6-months

Eligibility
Key inclusion criteria
Healthy adults (>18 yr) employed in full-time academic or general staff office positions at the University of Western Sydney Campbelltown campus; not currently engaged in regular yoga practice; no known chronic diseases; available to attend three yoga sessions per week during lunch break, ability to communicate in English; no acute or chronic medical conditions which would make yoga potentially hazardous or primary outcomes impossible to assess as outlined by the American College of Sports Medicine (ACSM); willingness and cognitive ability to provide written informed consent. Individuals deemed moderate-risk will require the approval of their physician prior to participation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
High-risk individuals will be excluded.

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)
Participants will be randomised via computer-generated randomly permuted blocks stratified by gender and age (<50yr; >50yr) into the experimental group and non-treatment control group. Group assignment will be delivered to participants in sealed envelopes upon the completion of baseline testing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An investigator not involved in testing or delivery of the intervention will prepare the randomization assignments using a computerised database (www.randomisation.com)
Masking / blinding
Blinded (masking 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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267131 0
University
Name [1] 267131 0
University of Western Sydney
Address [1] 267131 0
Locked Bag 1797, Penrith South DC, NSW 1797
Country [1] 267131 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797, Penrith South DC, NSW 1797
Country
Australia
Secondary sponsor category [1] 264206 0
None
Name [1] 264206 0
Address [1] 264206 0
Country [1] 264206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267118 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 267118 0
Locked Bag 1797, Penrith South DC, NSW 1797
Ethics committee country [1] 267118 0
Australia
Date submitted for ethics approval [1] 267118 0
01/09/2010
Approval date [1] 267118 0
05/11/2010
Ethics approval number [1] 267118 0
H8618

Summary
Brief summary
Background: Chronic work-related stress is a significant and independent risk factor for cardiometabolic diseases and associated mortality, particularly when compounded by inactivity. Heart rate variability (HRV) provides an estimate of parasympathetic and sympathetic autonomic control, and can serve as a marker of stress. Hatha yoga is a physically demanding and psychologically relaxing intervention that could mitigate work-related stress, however time constraints including work and family life may limit participation. The purpose of the present study is to determine the effect of a 10-week, worksite yoga program delivered during office hours (i.e. lunch break) on resting HRV and related physical and psychological parameters in a sedentary office workers with limited to no experience with yoga.
Methods and design: This is a parallel-arm RCT that will compare the outcomes of participants assigned to the experimental treatment arm (yoga) with those assigned to a non-treatment control group. The yoga intervention will be a progressive, beginners program, emphasize flowing physical postures (vinyasa) with an intention to improve psychological and physical markers of health status. The primary outcome of this study is parasympathetic control of heart function as determined by analysis of HRV. Secondary outcomes include measures of physical functioning and psychological health status, including anxiety, quality of life and job satisfaction. Measures will be collected prior to and following the intervention period, and at 6 months follow-up to determine the effect of withdrawal of the intervention.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 32652 0
Address 32652 0
Country 32652 0
Phone 32652 0
Fax 32652 0
Email 32652 0
Contact person for public queries
Name 15899 0
Dr. Birinder S. Cheema
Address 15899 0
Head of Program, Sr. Lecturer (Sport & Exercise Science)
School of Biomedical and Health Sciences
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW 1797
Country 15899 0
Australia
Phone 15899 0
+61 2 4620 3795
Fax 15899 0
+61 2 4620 3792
Email 15899 0
B.Cheema@uws.edu.au
Contact person for scientific queries
Name 6827 0
Dr. Birinder S. Cheema
Address 6827 0
Head of Program, Sr. Lecturer (Sport & Exercise Science)
School of Biomedical and Health Sciences
University of Western Sydney
Locked Bag 1797, Penrith South DC, NSW 1797
Country 6827 0
Australia
Phone 6827 0
+61 2 4620 3795
Fax 6827 0
+61 2 4620 3792
Email 6827 0
B.Cheema@uws.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary