Cardiovascular DiseaseNCT01592357
The Effects of Tai Chi in Older Patients With Cardiovascular Disease
A study testing Tai Chi exercise in people with Cardiovascular Disease, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Tai Chi exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Walking Speed < or = 1.3 m/sec during the gait speed assessment.
- Evidence of cardiovascular disease based on a diagnosis of previous myocardial infarction, angiographic findings of coronary artery disease, previous percutaneous coronary intervention, or previous coronary artery bypass graft surgery.
- Local resident, with available transportation to the Cardiac Health and Rehabilitation Centre (CHRC) at the Hamilton Health Sciences General Division.
- Ability to understand written and verbal instructions and provide written informed consent.
- Stable cardiac medical therapy as demonstrated by no change in medication during the 3 months prior to randomization.
- Previous completion of the 6 month Cardiac Rehabilitation program (including exercise training component) at the CHRC.
Who cannot join
- New York Heart Association Functional class IV symptoms of shortness of breath or angina.
- Development of angina or ST segment depression of > 1 mm during symptom limited exercise testing at < 80% of predicted maximum power output.
- Development of dysrhythmias during exercise (> Lown grade 2).
- Resting blood pressure greater than 160 mmHg systolic or 90 mmHg diastolic.
- Abnormal blood pressure response to clinical exercise testing (decrease in systolic pressure below resting; decrease of > 20 mmHg in systolic pressure after the normal exercise increase; rise in diastolic blood pressure of > 15 mmHg; maximal systolic blood pressure in excess of 250 mmHg).
- Maximum heart rate < 100 beats per minute in the absence of beta blocker therapy.
- Respiratory limitation as assessed by pre-exercise pulmonary function testing (documented restrictive or obstructive lung disease; based on forced expired volume in 1 sec and/or vital capacity measurements < 70% of predicted).
- Major orthopedic disability.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
About this study
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Disease
- Being tested
- Tai Chi exercise, Sham Exercise
- Keywords
- cardiac rehabilitation, gait speed, mind body exercise, tai chi, cardiac disease, frail elderly
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi exerciseBehavioural
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 ExerciseBehavioural
Also called Control Group
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | Not described Receives: Behavioral: Tai Chi exercise |
| Sham Exercise | Sham comparator | Not described Receives: Behavioral: Sham Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (6)
Peak exercise oxygen uptake (VO2)
Peak VO2 will be measured while performing cycle ergometry exercise.
Measured: 24 weeks
Resting heart rate
Resting heart rate will be measured prior to participant performing a cycle ergometry exercise test.
Measured: 24 weeks
Blood pressure
Blood pressure will be measured prior to the participant performing a cycle ergometry exercise test.
Measured: 24 weeks
Balance assessment
Balance will be measured using the functional reach assessment and the single leg stance assessment.
Measured: 24 weeks
Health related quality of life (HRQOL)
The Medical Outcomes Short Form 36 will be used to measure HRQOL.
Measured: 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).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario, Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Robert McKelvie, McMaster University
- Investigators
- Robert S McKelvie, MD, PhD, Principal investigator, Hamilton Health Sciences CorporationHeather M Arthur, PhD, Study chair, McMaster UniversityGeorge Heckman, MD, MSc, Study chair, University of WaterlooNoori Akhtar-Danesh, PhD, Study chair, McMaster UniversityMaureen MacDonald, PhD, Study chair, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592357
- Sponsor's protocol ID
- NA7343
- Status last verified
- Mar 2013
- First submitted
- 14 Mar 2012
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tai Chi in Older Patients With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01592357
- Acronym / sponsor ID
- NA7343
- Conditions
- Cardiovascular Disease
- Keywords
- cardiac rehabilitation, gait speed, mind body exercise, tai chi, cardiac disease, frail elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario, Hamilton Health Sciences Corporation
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 7 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai Chi exercise |
| Sham Exercise | Sham comparator | Behavioral: Sham Exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Walking Speed < or = 1.3 m/sec during the gait speed assessment.
- Evidence of cardiovascular disease based on a diagnosis of previous myocardial infarction, angiographic findings of coronary artery disease, previous percutaneous coronary intervention, or previous coronary artery bypass graft surgery.
- Local resident, with available transportation to the Cardiac Health and Rehabilitation Centre (CHRC) at the Hamilton Health Sciences General Division.
- Ability to understand written and verbal instructions and provide written informed consent.
- Stable cardiac medical therapy as demonstrated by no change in medication during the 3 months prior to randomization.
Key exclusion criteria (8 listed)
- New York Heart Association Functional class IV symptoms of shortness of breath or angina.
- Development of angina or ST segment depression of > 1 mm during symptom limited exercise testing at < 80% of predicted maximum power output.
- Development of dysrhythmias during exercise (> Lown grade 2).
- Resting blood pressure greater than 160 mmHg systolic or 90 mmHg diastolic.
- Abnormal blood pressure response to clinical exercise testing (decrease in systolic pressure below resting; decrease of > 20 mmHg in systolic pressure after the normal exercise increase; rise in diastolic blood pressure of > 15 mmHg; maximal systolic blood pressure in excess of 250 mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi exerciseA 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. | Behavioural | Tai Chi |
| Sham ExerciseAlso: Control GroupThe 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. | Behavioural | Sham Exercise |
Primary outcome
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.
6 secondary outcomes
Peak exercise oxygen uptake (VO2)
Time frame: 24 weeks
Resting heart rate
Time frame: 24 weeks
Blood pressure
Time frame: 24 weeks
Balance assessment
Time frame: 24 weeks
Health related quality of life (HRQOL)
Time frame: 24 weeks
Cognitive function following 6 months of Tai Chi or sham exercise training
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S McKelvie, MD, PhD principal investigator
Hamilton Health Sciences Corporation
Heather M Arthur, PhD study chair
McMaster University
George Heckman, MD, MSc study chair
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi exercise in people with Cardiovascular Disease, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed following 6 months of Tai Chi or sham exercise training (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.