Skip to main content
OpenTrials
Completed

NCT Number: NCT00110227

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12-week Tai Chi Program

Behavioral

24 tai chi sessions. 2 sessions/week for 12 weeks.

12-week Education Program

Behavioral

24 Educational sessions. 2 sessions/week for 12 weeks.

Primary outcomes

  1. HF-specific quality of life

    Time frame: baseline, midpoint, endpoint, 6mo

  2. functional capacity

    Time frame: baseline and endpoint

  3. Walking Test

    Time frame: baseline, midpoint, endpoint

Secondary outcomes

  1. General quality of life

    Time frame: baseline, midpoint, endpoint, 6mo

  2. mood and emotional status

    Time frame: baseline, midpoint, endpoint, 6mo

  3. exercise self-efficacy

    Time frame: baseline, midpoint, endpoint, 6mo

  4. sense of coherence

    Time frame: baseline, midpoint, endpoint, 6mo

  5. utility assessment

    Time frame: baseline, midpoint, endpoint, 6mo

  6. beliefs, attitudes, and expectations

    Time frame: baseline, midpoint, endpoint

  7. physical activity level

    Time frame: baseline, midpoint, endpoint

  8. perceived social support

    Time frame: baseline, midpoint, endpoint

  9. neurohormonal status

    Time frame: baseline, midpoint, endpoint

  10. autonomic tone, heart rate variability

    Time frame: baseline and endpoint

  11. echocardiography

    Time frame: baseline and endpoint

  12. costs and use of HF services

    Time frame: baseline and endpoint

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: NEXT-Heart

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
May 5, 2005
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.