The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001204437
Ethics application status
Approved
Date submitted
29/08/2016
Date registered
31/08/2016
Date last updated
10/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tai Chi for stress and cardiovascular function
Scientific title
Tai Chi for stress and cardiovascular function in patients with coronary heart disease and/or hypertension: a randomised controlled trial
Secondary ID [1] 287903 0
Nil known
Universal Trial Number (UTN)
U1111-1185-2454
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary heart disease 296830 0
hypertension 296831 0
Condition category
Condition code
Cardiovascular 297058 297058 0 0
Coronary heart disease
Cardiovascular 297059 297059 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be offered a standardised Tai Chi intervention over a period of 24 weeks, consisting of a 12 week intensive Tai Chi intervention and a 12-week sustained Tai Chi intervention.

In the intensive period the Tai Chi class of 60-90 minutes will take place twice per week, while in the sustained period the Tai Chi class of 60-90 minutes will take place once per week. Attendance will be recorded by the Tai Chi instructor each class. Participants will be required to practice at least 3 other days per week at home. Printed materials containing pictures and written descriptions of the Tai Chi intervention or DVDs will be provided to facilitate home practice. A self-report patient diary for recording the home practice sessions will need to be completed.

The overall contents of classes include Tai Chi history, theories and principles, meditation, walking lunges, 13-form Chen-style Tai Chi modified from the classical Chen-style Tai Chi, and 13-form Tai Chi cool-down exercise. Each class consists of 10-20 minutes of meditation, 10-20 minutes of walking lunges, 30 minutes of Tai Chi practice, and 10-20 minutes of Tai Chi cool-down exercise. Participants will be able to learn the entire sequence by the end of the 6th week, and the entire sequence will be repeated in the following weeks.

Patients assigned to the wait list control group will be instructed to maintain their routine activities and not to begin any new exercise programs during their study participation. These patients will be offered an equivalent 12-week intensive Tai Chi intervention and 12-week sustained Tai Chi intervention at the termination of the study provided the Tai Chi intervention in the treatment is proved to be safe (no severe adverse events directly associated with Tai Chi).
Intervention code [1] 293298 0
Treatment: Other
Intervention code [2] 295281 0
Rehabilitation
Comparator / control treatment
Patients assigned to the wait list control group will be instructed to maintain their routine activities and not to begin any new exercise programs during their study participation. These patients will be offered an equivalent 12-week intensive Tai Chi intervention and 12-week sustained Tai Chi intervention at the termination of the study provided the Tai Chi intervention in the treatment is proved to be safe (no severe adverse events directly associated with Tai Chi).
Control group
Active

Outcomes
Primary outcome [1] 296661 0
Stress measured by Perceived Stress Scale 10-item (PSS-10)
Timepoint [1] 296661 0
Baseline, and at 12 and 24 weeks after intervention commencement
Secondary outcome [1] 319052 0
Anxiety measured by Zung Self-Rating Anxiety Scale (SAS)
Timepoint [1] 319052 0
Baseline, and at 12 and 24 weeks after intervention commencement
Secondary outcome [2] 319053 0
Depression measured by Beck Depression Inventory-II (BDI-II)
Timepoint [2] 319053 0
Baseline, and at 12 and 24 weeks after intervention commencement
Secondary outcome [3] 319057 0
Blood Pressure measured by automatic sphygmomanometer
Timepoint [3] 319057 0
Baseline, and at 12 and 24 weeks after intervention commencement
Secondary outcome [4] 319059 0
Heart rate measured by automatic sphygmomanometer
Timepoint [4] 319059 0
Baseline, and at 12 and 24 weeks after intervention commencement
Secondary outcome [5] 319060 0
Heart Rate Variability (HRV) measured by SphygmaCor system
Timepoint [5] 319060 0
Baseline, and at 12 and 24 weeks after intervention commencement
Secondary outcome [6] 319061 0
C - Reactive Protein (CRP) assessed using blood samples test
Timepoint [6] 319061 0
Baseline, and at 12 and 24 weeks after intervention commencement
Secondary outcome [7] 319062 0
Lipid Profile assessed using blood samples test
Timepoint [7] 319062 0
Baseline, and at 12 and 24 weeks after intervention commencement
Secondary outcome [8] 319063 0
Glucose Profile assessed using blood samples test
Timepoint [8] 319063 0
Baseline, and at 12 and 24 weeks after intervention commencement
Secondary outcome [9] 319064 0
Quality of life assessed using the 36-item Short Form Health Survey Questionnaire (SF-36)
Timepoint [9] 319064 0
Baseline, and at 12 and 24 weeks after intervention commencement
Secondary outcome [10] 319066 0
Physical fitness assessed using 6-Minute Walk Test (6MWT)
Timepoint [10] 319066 0
Baseline, and at 12 and 24 weeks.
Secondary outcome [11] 319067 0
Compliance
Participants will be asked to complete a weekly diary documenting their practice at home. Their attendance of each Tai Chi class will also be documented by the instructor and the attendance rate will be calculated at the end of study.
Timepoint [11] 319067 0
After intervention commencement
Secondary outcome [12] 319068 0
Other Assessments
Participants will be asked to complete a diary weekly documenting major changes in regards to medication use, diet, exercise and negative behaviours such as alcohol consumption and smoking to assess potentially confounding variables.
Timepoint [12] 319068 0
Weekly after intervention commencement
Secondary outcome [13] 319069 0
Safety

The standardized Tai Chi intervention is specifically tailored to this CHD and hypertension population. Tai Chi instructors of this trial are appropriately qualified and experienced. All Adverse Events (AE) will be recorded and signed off by the principal investigator. During home practice, all potential adverse events will be recorded in diaries by the participants. If there is a Serious Adverse Event (SAE), the participant will contact the principal investigator (contact details will be provided on Participant Information Sheets). SAEs will be immediately reported to local Human Research Ethics Committees in accordance with the guidelines.
Timepoint [13] 319069 0
From the begining of the study till the end of the study.
Secondary outcome [14] 325600 0
Perceptions on facilitators and barriers to trial participation, compliance and adherence explored by an exit interview
Timepoint [14] 325600 0
at 24 weeks after intervention commencement

Eligibility
Key inclusion criteria
(1) Eaqual to or greater than 40 years of age, regardless of gender;
(2) With documented diagnosis of CHD (myocardial infarction, angina or revascularization) with severity of angina class I to II according to the Canadian Cardiovascular Society functional classification, and/or with established diagnosis of hypertension according to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure;
(3) Ability to perform prescribed Tai Chi program;
(4) Willing to complete the 24-week Tai Chi intervention;
(5) Not practicing Tai Chi in the past 6 months;
(6) Ability to speak and read Chinese or English fluently;
(7) Willing to sign a written informed consent.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Pregnancy
(2) Previous or current psychological disorders not associated with depression or anxiety
(3) End stage congestive heart failure
(4) Permanent bed-bound status
(5) Unstable abdominal, thoracic or cerebral aneurysm
(6) Acute myocarditis, pericarditis, pulmonary embolus or pulmonary infarction
(7) Significant limitation of physical activity for reasons other than CHD
(8) Participation in a clinical trial for an experimental drug within the last 30 days before the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved by using sequentially numbered, sealed, and opaque envelopes. Envelopes will be opened sequentially only after participant details are written on the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned into one of two parallel groups in a 1:1 ratio. An independent person will generate the random allocation sequence.by a computer-generated randomization list, using a 1:1 allocation ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
We will use SPSS version 20 to perform data analysis. ANOVA and Chi-squared tests will be used to check for any differences between groups at baseline. We will apply ANCOVA to detect changes between the experimental and control groups after treatment, controlling for baseline values and other possible confounders. A p value of less than 0.05 will be considered as statistically significant. An interim sample size analysis will also be conducted at n=50 allowing for an acceptable estimate of the population standard deviation and hence considerably more robust sample size calculation to ensure adequate power.

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)
NSW
Recruitment outside Australia
Country [1] 7350 0
China
State/province [1] 7350 0
Beijing

Funding & Sponsors
Funding source category [1] 292430 0
University
Name [1] 292430 0
Western Sydney University
Address [1] 292430 0
NICM Health Research Institute,
Western Sydney University
Building J, Westmead Campus.
Locked bag 1797 Penrith NSW 2751
Country [1] 292430 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
NICM Health Research Institute,
Western Sydney University
Building J, Westmead Campus.
Locked bag 1797 Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 291122 0
Hospital
Name [1] 291122 0
Cardiac Health Institute (CHI)
Address [1] 291122 0
CHI EASTWOOD
173 Shaftsbury Road,
Eastwood
NSW 2122
Country [1] 291122 0
Australia
Secondary sponsor category [2] 292860 0
University
Name [2] 292860 0
Beijing University of Chinese Medicine
Address [2] 292860 0
No. 11 Bei San Huan Dong Lu
Chaoyang District, Beijing 100029
Country [2] 292860 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293919 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 293919 0
Locked Bag 1797
Penrith NSW 2751 Australia
Office of Research Services
Ethics committee country [1] 293919 0
Australia
Date submitted for ethics approval [1] 293919 0
25/05/2015
Approval date [1] 293919 0
29/06/2015
Ethics approval number [1] 293919 0
H11189
Ethics committee name [2] 295452 0
Beijing University of Chinese Medicine Human Research Ethics Committee
Ethics committee address [2] 295452 0
No. 11 Bei San Huan Dong Lu,
Chaoyang Distriact, Beijing 100029
Ethics committee country [2] 295452 0
China
Date submitted for ethics approval [2] 295452 0
16/07/2015
Approval date [2] 295452 0
17/07/2015
Ethics approval number [2] 295452 0
2015BZHYLL0233

Summary
Brief summary
This is a prospective, randomised controlled trial designed to investigate the effect of a standardised Tai Chi intervention on psychological stress and cardiovascular function in patients with coronary heart disease and/or hypertension. The primary outcome will be psychosocial status of stress measured by Perceived Stress Scale 10-item (PSS-10). The secondary outcomes will include psychosocial status of anxiety measured by Zung Self-Rating Anxiety Scale (SAS), and depression measured by Beck Depression Inventory-II (BDI-II), cardiovascular function including blood pressure, heart rate, heart rate variability (HRV), blood tests (lipid and glucose profiles and C-creative protein (CRP), quality of life measured by Seattle Angina Questionnaire (SAQ), and physical fitness using the 6-Minute Walk test. Approximately 126 participants with coronary heart disease and/or hypertension will be included in this trial to participate a 24-week Tai Chi intervention, comprising of a 12-week intensive intervention and 12-week sustained intervention. This study will be conducted in Sydney, Australia and Beijing, China.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61558 0
Prof Dennis Chang
Address 61558 0
NICM Health Research Institute,
Western Sydney University
Building J, Westmead Campus.
Locked bag 1797 Penrith NSW 2751
Country 61558 0
Australia
Phone 61558 0
+61 2 4620 3920
Fax 61558 0
Email 61558 0
d.chang@westernsydney.edu.au
Contact person for public queries
Name 61559 0
Ms Guo-Yan Yang
Address 61559 0
NICM Health Research Institute,
Western Sydney University
Building J, Westmead Campus.
Locked bag 1797 Penrith NSW 2751
Country 61559 0
Australia
Phone 61559 0
+61 2 9685 4700
Fax 61559 0
Email 61559 0
e.yang@westernsydney.edu.au
Contact person for scientific queries
Name 61560 0
Prof Dennis Chang
Address 61560 0
NICM Health Research Institute,
Western Sydney University
Building J, Westmead Campus.
Locked bag 1797 Penrith NSW 2751
Country 61560 0
Australia
Phone 61560 0
+61 2 4620 3920
Fax 61560 0
Email 61560 0
d.chang@westernsydney.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