NCT00110227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 heart-failure

Timeline
Completed

Started Sep 2005

Typical duration for phase_3 heart-failure

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

3.3 years

First QC Date

May 4, 2005

Last Update Submit

February 23, 2017

Conditions

Heart Failure

Keywords

Complementary TherapiesTai Chi

Outcome Measures

Primary Outcomes (3)

  • HF-specific quality of life

    baseline, midpoint, endpoint, 6mo

  • functional capacity

    baseline and endpoint

  • Walking Test

    baseline, midpoint, endpoint

Secondary Outcomes (12)

  • General quality of life

    baseline, midpoint, endpoint, 6mo

  • mood and emotional status

    baseline, midpoint, endpoint, 6mo

  • exercise self-efficacy

    baseline, midpoint, endpoint, 6mo

  • sense of coherence

    baseline, midpoint, endpoint, 6mo

  • utility assessment

    baseline, midpoint, endpoint, 6mo

  • +7 more secondary outcomes

Study Arms (2)

Tai Chi

EXPERIMENTAL

12-week tai chi program

Behavioral: 12-week Tai Chi Program

Heart Health Education

ACTIVE COMPARATOR

12-week attention control

Behavioral: 12-week Education Program

Interventions

12-week Tai Chi ProgramBEHAVIORAL

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

Tai Chi
12-week Education ProgramBEHAVIORAL

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

Heart Health Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center, Harvard Medical School

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Lown Cardiovascular Center

Brookline, Massachusetts, 02446, United States

Location

Related Publications (2)

  • 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.

    PMID: 15465501BACKGROUND

  • 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.

    PMID: 21518942RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Russell S. Phillips, MD

    Beth Israel Deaconess Medical Center, Harvard Medical School

    PRINCIPAL INVESTIGATOR

  • Ellen P. McCarthy, PhD

    Beth Israel Deaconess Medical Center, Harvard Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 4, 2005

First Posted

May 5, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2009

Study Completion

July 1, 2009

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

US(4)