The Effects of Tai Chi in Older Patients With Cardiovascular Disease
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|ClinicalTrials.gov Identifier: NCT01592357|
Recruitment Status : Unknown
Verified March 2013 by Robert McKelvie, McMaster University.
Recruitment status was: Active, not recruiting
First Posted : May 7, 2012
Last Update Posted : March 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Behavioral: Tai Chi exercise Behavioral: Sham Exercise||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effects of Tai Chi in Older Patients With Cardiovascular Disease|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
|Experimental: Tai Chi||
Behavioral: Tai Chi 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.
|Sham Comparator: Sham Exercise||
Behavioral: Sham Exercise
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.
Other Name: Control Group
- Gait speed following 6 months of Tai Chi or sham exercise training [ Time Frame: 24 weeks ]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.
- Peak exercise oxygen uptake (VO2) [ Time Frame: 24 weeks ]Peak VO2 will be measured while performing cycle ergometry exercise.
- Resting heart rate [ Time Frame: 24 weeks ]Resting heart rate will be measured prior to participant performing a cycle ergometry exercise test.
- Blood pressure [ Time Frame: 24 weeks ]Blood pressure will be measured prior to the participant performing a cycle ergometry exercise test.
- Balance assessment [ Time Frame: 24 weeks ]Balance will be measured using the functional reach assessment and the single leg stance assessment.
- Health related quality of life (HRQOL) [ Time Frame: 24 weeks ]The Medical Outcomes Short Form 36 will be used to measure HRQOL.
- Cognitive function following 6 months of Tai Chi or sham exercise training [ Time Frame: 24 weeks ]Cognitive function will be measured using the Montreal Cognitive Assessment (MoCA) questionnaire (Version 7.1).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592357
|Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Robert S McKelvie, MD, PhD||Hamilton Health Sciences Corporation|
|Study Chair:||Heather M Arthur, PhD||McMaster University|
|Study Chair:||George Heckman, MD, MSc||University of Waterloo|
|Study Chair:||Noori Akhtar-Danesh, PhD||McMaster University|
|Study Chair:||Maureen MacDonald, PhD||McMaster University|