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

February 23, 2017 updated by: Gloria Y. Yeh, Beth Israel Deaconess Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HF-specific quality of life
Time Frame: baseline, midpoint, endpoint, 6mo
baseline, midpoint, endpoint, 6mo
functional capacity
Time Frame: baseline and endpoint
baseline and endpoint
Walking Test
Time Frame: baseline, midpoint, endpoint
baseline, midpoint, endpoint

Secondary Outcome Measures

Outcome Measure
Time Frame
General quality of life
Time Frame: baseline, midpoint, endpoint, 6mo
baseline, midpoint, endpoint, 6mo
mood and emotional status
Time Frame: baseline, midpoint, endpoint, 6mo
baseline, midpoint, endpoint, 6mo
exercise self-efficacy
Time Frame: baseline, midpoint, endpoint, 6mo
baseline, midpoint, endpoint, 6mo
sense of coherence
Time Frame: baseline, midpoint, endpoint, 6mo
baseline, midpoint, endpoint, 6mo
utility assessment
Time Frame: baseline, midpoint, endpoint, 6mo
baseline, midpoint, endpoint, 6mo
beliefs, attitudes, and expectations
Time Frame: baseline, midpoint, endpoint
baseline, midpoint, endpoint
physical activity level
Time Frame: baseline, midpoint, endpoint
baseline, midpoint, endpoint
perceived social support
Time Frame: baseline, midpoint, endpoint
baseline, midpoint, endpoint
neurohormonal status
Time Frame: baseline, midpoint, endpoint
baseline, midpoint, endpoint
autonomic tone, heart rate variability
Time Frame: baseline and endpoint
baseline and endpoint
echocardiography
Time Frame: baseline and endpoint
baseline and endpoint
costs and use of HF services
Time Frame: baseline and endpoint
baseline and endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 4, 2005

First Submitted That Met QC Criteria

May 4, 2005

First Posted (Estimate)

May 5, 2005

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004P000390
  • R01AT002454 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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