Clinical trial NCT00110227: Tai Chi Mind-Body Therapy for Chronic Heart Failure
Official title: Tai Chi Mind-Body Therapy for Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: Complementary Therapies
Tai Chi
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2005-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: HF-specific quality of life
timeFrame: baseline, midpoint, endpoint, 6mo
measure: functional capacity
timeFrame: baseline and endpoint
measure: Walking Test
timeFrame: baseline, midpoint, endpoint
Secondary outcomes:
measure: General quality of life
timeFrame: baseline, midpoint, endpoint, 6mo
measure: mood and emotional status
timeFrame: baseline, midpoint, endpoint, 6mo
measure: exercise self-efficacy
timeFrame: baseline, midpoint, endpoint, 6mo
measure: sense of coherence
timeFrame: baseline, midpoint, endpoint, 6mo
measure: utility assessment
timeFrame: baseline, midpoint, endpoint, 6mo
measure: beliefs, attitudes, and expectations
timeFrame: baseline, midpoint, endpoint
measure: physical activity level
timeFrame: baseline, midpoint, endpoint
measure: perceived social support
timeFrame: baseline, midpoint, endpoint
measure: neurohormonal status
timeFrame: baseline, midpoint, endpoint
measure: autonomic tone, heart rate variability
timeFrame: baseline and endpoint
measure: echocardiography
timeFrame: baseline and endpoint
measure: costs and use of HF services
timeFrame: baseline and endpoint
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Harvard Medical School
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Brookline
country: United States
facility: Lown Cardiovascular Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center, Harvard Medical School
name: Russell S. Phillips, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center, Harvard Medical School
name: Ellen P. McCarthy, PhD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.amjmed.2004.04.016.
citation: Yeh GY, McCarthy EP, Wayne PM, Stevenson LW, Wood MJ, Forman D, Davis RB, Phillips RS. Tai chi exercise in patients with chronic heart failure: a randomized clinical trial. Arch Intern Med. 2011 Apr 25;171(8):750-7. doi: 10.1001/archinternmed.2011.150.