Tai Chi Mind-Body Therapy for Chronic Heart Failure

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: 12-week Tai Chi Program; Behavioral: 12-week Education Program

• Registration Number: NCT00110227
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2005-05-04
• Study First Submitted QC: 2005-05-04
• Study First Posted: 2005-05-05
• Study Start: 2005-09
• Primary Completion: 2009-01
• Study Completion: 2009-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tai Chi	12-week Tai Chi Program	12-week tai chi program
Heart Health Education	12-week Education Program	12-week attention control

Primary Outcome Measures

Name	Time	Method
HF-specific quality of life	baseline, midpoint, endpoint, 6mo
functional capacity	baseline and endpoint
Walking Test	baseline, midpoint, endpoint

Secondary Outcome Measures

Name	Time	Method
echocardiography	baseline and endpoint
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
costs and use of HF services	baseline and endpoint

Trial Locations

Locations (4)

Lown Cardiovascular Center; 🇺🇸 Brookline, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Harvard Medical School; 🇺🇸 Boston, Massachusetts, United States