Tai Chi Mind-Body Therapy for Chronic Heart Failure

Beth Israel Deaconess Medical Center100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Heart Failure

Interventions

12-week Tai Chi ProgramBEHAVIORAL

24 tai chi sessions. 2 sessions/week for 12 weeks.

12-week Education ProgramBEHAVIORAL

24 Educational sessions. 2 sessions/week for 12 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Harvard Medical School

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Lown Cardiovascular Center

Brookline, Massachusetts, United States

Outcomes

Primary Outcomes

HF-specific quality of life

Time frame: baseline, midpoint, endpoint, 6mo

functional capacity

Time frame: baseline and endpoint

Walking Test

Time frame: baseline, midpoint, endpoint

Secondary Outcomes

General quality of life

Time frame: baseline, midpoint, endpoint, 6mo

mood and emotional status

Time frame: baseline, midpoint, endpoint, 6mo

exercise self-efficacy

Time frame: baseline, midpoint, endpoint, 6mo

sense of coherence

Time frame: baseline, midpoint, endpoint, 6mo

utility assessment

Time frame: baseline, midpoint, endpoint, 6mo

beliefs, attitudes, and expectations

Time frame: baseline, midpoint, endpoint

physical activity level

Time frame: baseline, midpoint, endpoint

perceived social support

Time frame: baseline, midpoint, endpoint

neurohormonal status

Time frame: baseline, midpoint, endpoint

Data from ClinicalTrials.gov

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