Tai Chi Mind-Body Therapy for Chronic Heart Failure - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00110227

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Behavioral: 12-week Tai Chi Program Behavioral: 12-week Education Program	Phase III

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Tai Chi Mind-Body Therapy for Chronic Heart Failure

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

HF-specific quality of life [ Time Frame: baseline, midpoint, endpoint, 6mo ] [ Designated as safety issue: No ]
functional capacity [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]
Walking Test [ Time Frame: baseline, midpoint, endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

General quality of life [ Time Frame: baseline, midpoint, endpoint, 6mo ] [ Designated as safety issue: No ]
mood and emotional status [ Time Frame: baseline, midpoint, endpoint, 6mo ] [ Designated as safety issue: No ]
exercise self-efficacy [ Time Frame: baseline, midpoint, endpoint, 6mo ] [ Designated as safety issue: No ]
sense of coherence [ Time Frame: baseline, midpoint, endpoint, 6mo ] [ Designated as safety issue: No ]
utility assessment [ Time Frame: baseline, midpoint, endpoint, 6mo ] [ Designated as safety issue: No ]
beliefs, attitudes, and expectations [ Time Frame: baseline, midpoint, endpoint ] [ Designated as safety issue: No ]
physical activity level [ Time Frame: baseline, midpoint, endpoint ] [ Designated as safety issue: No ]
perceived social support [ Time Frame: baseline, midpoint, endpoint ] [ Designated as safety issue: No ]
neurohormonal status [ Time Frame: baseline, midpoint, endpoint ] [ Designated as safety issue: No ]
autonomic tone, heart rate variability [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]
echocardiography [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]
costs and use of HF services [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tai Chi: Experimental 12-week tai chi program	Behavioral: 12-week Tai Chi Program 24 tai chi sessions. 2 sessions/week for 12 weeks.
Heart Health Education: Active Comparator 12-week attention control	Behavioral: 12-week Education Program 24 Educational sessions. 2 sessions/week for 12 weeks.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110227

Contacts

Contact: Ellen P. McCarthy, PhD	617-754-1403	emccarth@bidmc.harvard.edu
Contact: Russell S. Phillips, MD	617-667-4916	rphillip@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center, Harvard Medical School	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Russell S. Phillips, MD 617-667-4916 rphillip@bidmc.harvard.edu
Contact: Ellen P. McCarthy, PhD 617-754-1403 emccarth@bidmc.harvard.edu
Principal Investigator: Russell S. Phillips, MD
Sub-Investigator: Ellen P. McCarthy, PhD
Sub-Investigator: Gloria Yeh, MD
Sub-Investigator: Ary Goldberger, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Malissa J. Wood, MD 617-726-0995 mjwood@partners.org
Sub-Investigator: Malissa J. Wood, MD
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lynne W. Stevenson, MD 617-732-7406 lstevenson@partners.org
Sub-Investigator: Lynne W. Stevenson, MD
Sub-Investigator: Daniel E. Forman, MD
Lown Cardiovascular Center	Recruiting
Brookline, Massachusetts, United States, 02446
Sub-Investigator: Charles Blatt, MD

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:	Russell S. Phillips, MD	Beth Israel Deaconess Medical Center, Harvard Medical School
Study Director:	Ellen P. McCarthy, PhD	Beth Israel Deaconess Medical Center, Harvard Medical School

More Information

Publications:

Yeh GY, Wood MJ, Lorell BH, Stevenson LW, Eisenberg DM, Wayne PM, Goldberger AL, Davis RB, Phillips RS. Effects of tai chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: a randomized controlled trial. Am J Med. 2004 Oct 15;117(8):541-8.

Responsible Party:	Beth Israel Deaconess Medical Center, Harvard Medical School ( Russell Phillips, MD, Chief Division of General Medicine & Primary Care )
Study ID Numbers:	R01 AT002454
Study First Received:	May 4, 2005
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00110227 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Complementary Therapies
Tai Chi

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009