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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
12-week Tai Chi Program
12-week Education Program
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Complementary Therapies, Tai Chi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center, Harvard Medical School
  • Brigham and Women's Hospital
  • Lown Cardiovascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tai Chi

Heart Health Education

Arm Description

12-week tai chi program

12-week attention control

Outcomes

Primary Outcome Measures

HF-specific quality of life
functional capacity
Walking Test

Secondary Outcome Measures

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, heart rate variability
echocardiography
costs and use of HF services

Full Information

First Posted
May 4, 2005
Last Updated
February 23, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00110227
Brief Title
Tai Chi Mind-Body Therapy for Chronic Heart Failure
Acronym
NEXT-Heart
Official Title
Tai Chi Mind-Body Therapy for Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Complementary Therapies, Tai Chi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
12-week tai chi program
Arm Title
Heart Health Education
Arm Type
Active Comparator
Arm Description
12-week attention control
Intervention Type
Behavioral
Intervention Name(s)
12-week Tai Chi Program
Intervention Description
24 tai chi sessions. 2 sessions/week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
12-week Education Program
Intervention Description
24 Educational sessions. 2 sessions/week for 12 weeks.
Primary Outcome Measure Information:
Title
HF-specific quality of life
Time Frame
baseline, midpoint, endpoint, 6mo
Title
functional capacity
Time Frame
baseline and endpoint
Title
Walking Test
Time Frame
baseline, midpoint, endpoint
Secondary Outcome Measure Information:
Title
General quality of life
Time Frame
baseline, midpoint, endpoint, 6mo
Title
mood and emotional status
Time Frame
baseline, midpoint, endpoint, 6mo
Title
exercise self-efficacy
Time Frame
baseline, midpoint, endpoint, 6mo
Title
sense of coherence
Time Frame
baseline, midpoint, endpoint, 6mo
Title
utility assessment
Time Frame
baseline, midpoint, endpoint, 6mo
Title
beliefs, attitudes, and expectations
Time Frame
baseline, midpoint, endpoint
Title
physical activity level
Time Frame
baseline, midpoint, endpoint
Title
perceived social support
Time Frame
baseline, midpoint, endpoint
Title
neurohormonal status
Time Frame
baseline, midpoint, endpoint
Title
autonomic tone, heart rate variability
Time Frame
baseline and endpoint
Title
echocardiography
Time Frame
baseline and endpoint
Title
costs and use of HF services
Time Frame
baseline and endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell S. Phillips, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center, Harvard Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen P. McCarthy, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center, Harvard Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center, Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lown Cardiovascular Center
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02446
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15465501
Citation
Yeh GY, Wood MJ, Lorell BH, Stevenson LW, Eisenberg DM, Wayne PM, Goldberger AL, Davis RB, Phillips RS. Effects of tai chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: a randomized controlled trial. Am J Med. 2004 Oct 15;117(8):541-8. doi: 10.1016/j.amjmed.2004.04.016.
Results Reference
background
PubMed Identifier
21518942
Citation
Yeh GY, McCarthy EP, Wayne PM, Stevenson LW, Wood MJ, Forman D, Davis RB, Phillips RS. Tai chi exercise in patients with chronic heart failure: a randomized clinical trial. Arch Intern Med. 2011 Apr 25;171(8):750-7. doi: 10.1001/archinternmed.2011.150.
Results Reference
result

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Tai Chi Mind-Body Therapy for Chronic Heart Failure

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