The Effects of Tai Chi in Older Patients With Cardiovascular Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Heart and Stroke Foundation of Ontario
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Robert McKelvie, McMaster University
ClinicalTrials.gov Identifier:
NCT01592357
First received: March 14, 2012
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Behavioral: Tai Chi exercise
Behavioral: Sham Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Tai Chi in Older Patients With Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Gait speed following 6 months of Tai Chi or sham exercise training [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Peak exercise oxygen uptake (VO2) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Peak VO2 will be measured while performing cycle ergometry exercise.

  • Resting heart rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Resting heart rate will be measured prior to participant performing a cycle ergometry exercise test.

  • Blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Blood pressure will be measured prior to the participant performing a cycle ergometry exercise test.

  • Balance assessment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cognitive function will be measured using the Montreal Cognitive Assessment (MoCA) questionnaire (Version 7.1).


Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Walking Speed < or = 1.3 m/sec during the gait speed assessment.
  2. 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.
  3. Local resident, with available transportation to the Cardiac Health and Rehabilitation Centre (CHRC) at the Hamilton Health Sciences General Division.
  4. Ability to understand written and verbal instructions and provide written informed consent.
  5. Stable cardiac medical therapy as demonstrated by no change in medication during the 3 months prior to randomization.
  6. Previous completion of the 6 month Cardiac Rehabilitation program (including exercise training component) at the CHRC.

Exclusion Criteria:

  1. New York Heart Association Functional class IV symptoms of shortness of breath or angina.
  2. Development of angina or ST segment depression of > 1 mm during symptom limited exercise testing at < 80% of predicted maximum power output.
  3. Development of dysrhythmias during exercise (> Lown grade 2).
  4. Resting blood pressure greater than 160 mmHg systolic or 90 mmHg diastolic.
  5. 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).
  6. Maximum heart rate < 100 beats per minute in the absence of beta blocker therapy.
  7. 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).
  8. Major orthopedic disability.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592357

Locations
Canada, Ontario
Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
McMaster University
Heart and Stroke Foundation of Ontario
Hamilton Health Sciences Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Robert McKelvie, Professor of Medicine, Division of Cardiology, Medical Director, Heart Failure Program, HHS Medical Director, Cardiac Health and Rehabilitation Program, HHS, McMaster University
ClinicalTrials.gov Identifier: NCT01592357     History of Changes
Other Study ID Numbers: NA7343
Study First Received: March 14, 2012
Last Updated: March 18, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
cardiac rehabilitation
gait speed
mind body exercise
tai chi
cardiac disease
frail elderly

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014