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

This study has been completed.
Sponsor:
Collaborator:
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

May 4, 2005
March 5, 2013
September 2005
January 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • HF-specific quality of life
  • functional capacity
  • Exercise capacity
Complete list of historical versions of study NCT00110227 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00110227
R01 AT002454, R01AT002454
Yes
Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
National Center for Complementary and Alternative Medicine (NCCAM)
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
March 2013

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