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Tai Chi Mind-Body Therapy for Chronic Heart Failure (NEXT-Heart)

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00110227
First received: May 4, 2005
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tai Chi Mind-Body Therapy for Chronic Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

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 ]

Enrollment: 100
Study Start Date: September 2005
Study Completion Date: July 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tai Chi
12-week tai chi program
 Behavioral: 12-week Tai Chi Program
24 tai chi sessions. 2 sessions/week for 12 weeks.
Active Comparator: Heart Health Education
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

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Lown Cardiovascular Center
Brookline, Massachusetts, United States, 02446
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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:

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00110227     History of Changes
Other Study ID Numbers: R01 AT002454, R01AT002454
Study First Received: May 4, 2005
Last Updated: March 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Beth Israel Deaconess Medical Center:
Complementary Therapies
Tai Chi

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013