The Effects of Tai Chi in Older Patients With Cardiovascular Disease

NCT01592357 | Unknown

• 1 other identifier: NA7343
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Disease

Keywords

cardiac rehabilitation; gait speed; mind body exercise; tai chi; cardiac disease; frail elderly

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (6)

• Peak exercise oxygen uptake (VO2)

  24 weeks

• Resting heart rate

  24 weeks

• Blood pressure

  24 weeks

• Balance assessment

  24 weeks

• Health related quality of life (HRQOL)

  24 weeks

Study Arms (2)

Tai Chi

EXPERIMENTAL

Behavioral: Tai Chi exercise

Sham Exercise

SHAM COMPARATOR

Behavioral: Sham Exercise

Interventions

Tai Chi exercise BEHAVIORAL

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.

Tai Chi

Sham Exercise BEHAVIORAL

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

Sham Exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Heart and Stroke Foundation of Ontario: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Cardiac Health & Rehabilitation Centre, Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases

Interventions

Aquatic Therapy; Control Groups

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Robert S McKelvie, MD, PhD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Division of Cardiology, Medical Director, Heart Failure Program, HHS Medical Director, Cardiac Health and Rehabilitation Program, HHS

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: May 7, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

CA (1)