Tai Chi Mind-Body Therapy for Chronic Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tai Chi

12-week tai chi program

Group Type EXPERIMENTAL

12-week Tai Chi Program

Intervention Type BEHAVIORAL

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

Heart Health Education

12-week attention control

Group Type ACTIVE_COMPARATOR

12-week Education Program

Intervention Type BEHAVIORAL

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

Interventions

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12-week Tai Chi Program

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

Intervention Type BEHAVIORAL

12-week Education Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No