The purpose of this study is to determine the effects of a tai chi exercise program on functional capacity and health-related quality of life in patients with chronic heart failure (HF). This study will also examine the way tai chi influences mental, physical, and social functioning.

Condition	Treatment or Intervention	Phase
Heart Failure	Behavior: 12-week tai chi program  Behavior: 12-week education program	Phase III

Further Study Details: 

Primary Outcomes: Exercise capacity; HF-specific quality of life; functional capacity
Secondary Outcomes: General quality of life; mood and emotional status; exercise self-efficacy; sense of coherence; utility assessment; beliefs, attitudes, and expectations; physical activity level; perceived social support; neurohormonal status; autonomic tone; echocardiography; costs and use of HF services
Expected Total Enrollment:  150

HF is a major public health problem in the United States, affecting approximately 5 million adults. Despite recent advances in pharmacologic therapy and technologic devices, HF is the most common reason for hospitalization among Medicare patients and is reaching epidemic proportions as the population ages. New and inexpensive interventions that can improve functional capacity and quality of life and can delay disease progression are needed. Tai chi is a popular mind-body exercise that is a potential treatment for heart disease. This exercise incorporates both gentle physical activity and meditation, and it may be particularly suited to frail patients with HF. This study will examine the effects of a tailored tai chi program on functional capacity and quality of life in patients with HF.

Participants will be randomly assigned to either a tai chi program or heart health education for 12 weeks. Participants in both groups will undergo a bicycle stress test at study entry and will receive weekly training sessions of their assigned intervention. Self-report scales and questionnaires will be used to assess participants at study start and at the end of 12 weeks.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of chronic HF
• Percentage of blood pumped from the left ventricle (ventricular ejection fraction) less than 40% for at least 1 year prior to study entry
• Stable medical regimen, defined as no major changes in medication, in the 3 months prior to study entry
• New York Heart Association Classification of Class I (no activity limitations), Class II (slight activity limitations), or Class III (marked activity limitations)
• English-speaking

Exclusion Criteria:

• Unstable angina, myocardial infarction, cardiac resynchronization, or major cardiac surgery within 3 months prior to study entry
• History of cardiac arrest or diagnosis of peripartum cardiomyopathy within 6 months prior to study entry
• Unstable ventricular arrhythmias or structural valvular disease
• Current participation in a conventional cardiac rehabilitation program
• Inability to perform a bicycle stress test at study entry
• Lower extremity amputation or other inability to walk due to conditions other than HF
• Severe cognitive dysfunction preventing informed consent and understanding of tai chi concept
• Current regular practice of tai chi
• Current participation in a tai chi pilot study or other studies

Please refer to this study by ClinicalTrials.gov identifier  NCT00110227

Ellen P. McCarthy, PhD      617-667-1299    emccarth@bidmc.harvard.edu
Russell S. Phillips, MD      617-667-4916    rphillip@bidmc.harvard.edu

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Not yet recruiting
      Brigham and Women's Hospital, Boston,  Massachusetts,  02215,  United States; Not yet recruiting

Study chairs or principal investigators

Russell S. Phillips, MD,  Principal Investigator,  Beth Israel Deaconess Medical Center   
Ellen P. McCarthy, PhD,  Study Director,  Beth Israel Deaconess Medical Center   

Study ID Numbers:  R01 AT002454
Record last reviewed:  May 2005
Last Updated:  May 4, 2005
Record first received:  May 4, 2005
ClinicalTrials.gov Identifier:  NCT00110227
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-17