An interventional study of Tai Chi exercise and Sham Exercise in Cardiovascular Disease, sponsored by McMaster University. Status unknown at 1 site in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2013-03-19.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
Cardiac exercise rehabilitation consists of walking and bicycling activities. As the population requiring rehabilitation is aging, other forms of exercise may be useful and better tolerated. Tai Chi has been used for centuries, is easy to perform even by more debilitated individuals, and promotes improvement in blood pressure, fitness, and relaxation. Tai Chi may be more beneficial for frail cardiac patients because it is especially suited for the unfit and elderly, and can be practiced anywhere. Further studies are required to assess this form of exercise in cardiac patients. The objective of this randomized controlled study is to compare the effects of Tai Chi to "sham exercise" training in 200 frail cardiac patients who have completed six months of cardiac rehabilitation and are 60 years of age or older. Participants will be randomized to Tai Chi or "sham exercise" training and have their gait speed, blood pressure, heart rate, exercise capacity, balance, quality of life and cognitive function assessed before and after 24 week of training.
The role of exercise training is well established for cardiac patients to improve fitness and clinical outcomes. Many older cardiac patients even if they initially participate do not maintain regular exercise for a number of reasons. As the population ages there is a need to evaluate other forms of exercise training that may be used alone or in conjunction with standard approaches. Tai Chi is a potentially beneficial exercise for older cardiac patients because it is low-intensity exercise especially suited for unfit and elderly patients. There has been little rigorous evaluation, especially in the cardiac populations, of Tai Chi.
The main objective of this study is to assess the effects of Tai Chi compared to "sham exercise" in cardiac patients that have completed a program of cardiac rehabilitation. The investigators hope to show that six months of Tai Chi training compared to "sham exercise" (with all participants instructed to maintain their standard exercise program), will improve gait speed, exercise capacity, health related quality of life, cognitive function and balance.
This is a single blind randomized controlled trial of 200 cardiac patients, great than or equal to 60 years of age, who have completed six months of cardiac rehabilitation at the Hamilton Health Science Cardiac Health and Rehabilitation Centre. Participants will be randomized to receive either the short and simple 8-forms Tai Chi routine or "sham exercise". The participants in the study will train for a period of six months.
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Exclusion Criteria:
Behavioral: Tai Chi exercise
Behavioral: Sham Exercise
A short and simple 8-forms Tai Chi routine will be used in this study. This routine has been previously standardized and field tested. Participants will be coached, by a certified Tai Chi instructor, in practicing the proper mechanics of executing each of the eight physical movements comprising the 8-forms of Tai Chi. A brief 5 minute period of walking calisthenics pertinent to Tai Chi movements, postures and diaphragmatic breathing will take place before training to warm up and after training to cool down. The Tai Chi training will be 2 times a week and the total exercise time, including warm-up and cool down, will be 50 minutes for each session. Over a period of 12 weeks, the participants will learn all 8-forms and continue practicing them for the final 12 weeks of the training period.
The sham exercise (control) group will be involved in low-intensity stretching exercises two times per week. These exercises will be designed as a "sham exercise" condition. A brief 5 minute period of walking will take place before the sham exercise to warm up and after the sham exercise to cool down. Sham exercise sessions will include stretching exercises of the neck, trunk and extremities. The total exercise time for the "sham exercise" group will be 50 minutes and participants will meet 2 times per week for a period of 24 weeks.
Also known as: Control Group
Gait speed following 6 months of Tai Chi or sham exercise training
Gait speed will be measured by having participants walk a 4 metre course at their usual speed. There will be a 1-metre start-up before starting the timing for the walk over 4 metres. Each participant will be timed for 2 walks and the faster of the 2 walks will be used in the analysis.
Time frame: 24 weeks
Peak exercise oxygen uptake (VO2)
Peak VO2 will be measured while performing cycle ergometry exercise.
Time frame: 24 weeks
Resting heart rate
Resting heart rate will be measured prior to participant performing a cycle ergometry exercise test.
Time frame: 24 weeks
Blood pressure
Blood pressure will be measured prior to the participant performing a cycle ergometry exercise test.
Time frame: 24 weeks
Balance assessment
Balance will be measured using the functional reach assessment and the single leg stance assessment.
Time frame: 24 weeks
Health related quality of life (HRQOL)
The Medical Outcomes Short Form 36 will be used to measure HRQOL.
Time frame: 24 weeks
Cognitive function following 6 months of Tai Chi or sham exercise training
Cognitive function will be measured using the Montreal Cognitive Assessment (MoCA) questionnaire (Version 7.1).
Time frame: 24 weeks
This study is status unknown, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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