None listed
Conditions
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.
Interventions
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).
Sponsors
Study design
Eligibility
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.
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