Tai Chi Mind-Body Therapy for Chronic Heart Failure

Study Overview
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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.

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.

Official Title
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Tai Chi Mind-Body Therapy for Chronic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: 12-week Tai Chi Program
* Behavioral: 12-week Education Program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi<br>12-week tai chi program | Behavioral: 12-week Tai Chi Program<br>* 24 tai chi sessions. 2 sessions/week for 12 weeks.<br>|
| Active Comparator: Heart Health Education<br>12-week attention control | Behavioral: 12-week Education Program<br>* 24 Educational sessions. 2 sessions/week for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HF-specific quality of life |  | baseline, midpoint, endpoint, 6mo | 
| functional capacity |  | baseline and endpoint | 
| Walking Test |  | baseline, midpoint, endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General quality of life |  | baseline, midpoint, endpoint, 6mo | 
| mood and emotional status |  | baseline, midpoint, endpoint, 6mo | 
| exercise self-efficacy |  | baseline, midpoint, endpoint, 6mo | 
| sense of coherence |  | baseline, midpoint, endpoint, 6mo | 
| utility assessment |  | baseline, midpoint, endpoint, 6mo | 
| beliefs, attitudes, and expectations |  | baseline, midpoint, endpoint | 
| physical activity level |  | baseline, midpoint, endpoint | 
| perceived social support |  | baseline, midpoint, endpoint | 
| neurohormonal status |  | baseline, midpoint, endpoint | 
| autonomic tone, heart rate variability |  | baseline and endpoint | 
| echocardiography |  | baseline and endpoint | 
| costs and use of HF services |  | baseline and endpoint | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complementary Therapies, Tai Chi