Heart Failure Clinical Trial

Tai Chi Mind-Body Therapy for Chronic Heart Failure

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT00110227

Recruitment Status:

Completed

Sponsor:

Beth Israel Deaconess Medical Center

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There are 3 Locations for this study

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Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston Massachusetts, 02215, United States
Brigham and Women's Hospital
Boston Massachusetts, 02215, United States
Lown Cardiovascular Center
Brookline Massachusetts, 02446, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT00110227

Recruitment Status:

Completed

Sponsor:


Beth Israel Deaconess Medical Center

How clear is this clinincal trial information?

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