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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00110227
First Posted: May 5, 2005
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gloria Y. Yeh, Beth Israel Deaconess Medical Center
May 4, 2005
May 5, 2005
February 27, 2017
September 2005
January 2009   (Final data collection date for primary outcome measure)
  • HF-specific quality of life [ Time Frame: baseline, midpoint, endpoint, 6mo ]
  • functional capacity [ Time Frame: baseline and endpoint ]
  • Walking Test [ Time Frame: baseline, midpoint, endpoint ]
  • Exercise capacity
  • HF-specific quality of life
  • functional capacity
Complete list of historical versions of study NCT00110227 on ClinicalTrials.gov Archive Site
  • General quality of life [ Time Frame: baseline, midpoint, endpoint, 6mo ]
  • mood and emotional status [ Time Frame: baseline, midpoint, endpoint, 6mo ]
  • exercise self-efficacy [ Time Frame: baseline, midpoint, endpoint, 6mo ]
  • sense of coherence [ Time Frame: baseline, midpoint, endpoint, 6mo ]
  • utility assessment [ Time Frame: baseline, midpoint, endpoint, 6mo ]
  • beliefs, attitudes, and expectations [ Time Frame: baseline, midpoint, endpoint ]
  • physical activity level [ Time Frame: baseline, midpoint, endpoint ]
  • perceived social support [ Time Frame: baseline, midpoint, endpoint ]
  • neurohormonal status [ Time Frame: baseline, midpoint, endpoint ]
  • autonomic tone, heart rate variability [ Time Frame: baseline and endpoint ]
  • echocardiography [ Time Frame: baseline and endpoint ]
  • costs and use of HF services [ Time Frame: baseline and endpoint ]
  • General quality of life
  • mood and emotional status
  • exercise self-efficacy
  • sense of coherence
  • utility assessment
  • beliefs, attitudes, and expectations
  • physical activity level
  • perceived social support
  • neurohormonal status
  • autonomic tone
  • echocardiography
  • costs and use of HF services
Not Provided
Not Provided
 
Tai Chi Mind-Body Therapy for Chronic Heart Failure
Tai Chi Mind-Body Therapy for Chronic Heart Failure
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Behavioral: 12-week Tai Chi Program
    24 tai chi sessions. 2 sessions/week for 12 weeks.
  • Behavioral: 12-week Education Program
    24 Educational sessions. 2 sessions/week for 12 weeks.
  • Experimental: Tai Chi
    12-week tai chi program
    Intervention: Behavioral: 12-week Tai Chi Program
  • Active Comparator: Heart Health Education
    12-week attention control
    Intervention: Behavioral: 12-week Education Program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00110227
2004P000390
R01AT002454 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Gloria Y. Yeh, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
National Center for Complementary and Integrative Health (NCCIH)
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
Beth Israel Deaconess Medical Center
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP