Exploring Behavioral Interventions to Improve Heart Failure

January 7, 2016 updated by: Laura S. Redwine, PhD, University of California, San Diego

Exploring Tai Chi as a Behavioral Intervention for Heart Failure Patients

The objective of this research is to compare Tai Chi versus Resistance Exercise, Health Education and usual care for changes in cardiac functional capacity measured for ability of the heart to pump by measuring ejection fraction (EF), end systolic and diastolic volumes in heart failure (HF) patients. Also measured will be changes in physical function measured by walking speed and distance in the 6-min walk task, work performed during a bicycle task, and changes in daily physical activity. The investigators will compare groups for altered well-being including: depression, sleep disturbances, fatigue, mindfulness, spirituality and quality of life. In addition the investigators will compare groups for altered vascular and pro-inflammatory markers, catecholamines, and autonomic function at rest and in response to the bicycle task. Also, the investigators will assess cardiac related hospitalization and death over a 12 month period by examining medical records.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
    • California
      • La Jolla, California, United States, 92093
        • University of Califoria, San Diego

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ability to perform a 6-minute walk task, with or without use of a cane or walker (must use the same walking assistance device during each session), and walk under 500 meters during task.
  2. Symptoms of chronic heart failure for at least 3 months.
  3. Clinically stable- defined as not having been hospitalized for a 3 month period, on stable doses of neurohormonal blocking agents and diuretics for at least 3 months.
  4. ACC/AHA stages B and C
  5. Ability to perform light to moderate exercise (NYHA functional class II and III)
  6. Presence of HF with an ejection fraction less than 40%, or diastolic dysfunction
  7. Ability to give informed consent
  8. At least18 years of age

Exclusion Criteria:

  1. History of recent myocardial infarction (1 month)
  2. Angina not adequately managed with nitrates.
  3. Aortic or mitral stenosis
  4. Coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 6 months.
  5. Severe COPD
  6. Recent stroke or significant cerebral neurologic impairment.
  7. Active Suicidality
  8. Currently participating in an exercise program.
  9. Currently taking mood stabilizers (e.g. lithium), benzodiazepines or antipsychotics.
  10. Medications (steroids) and medical conditions affecting immune status not limited to Grave's Disease, Rheumatoid Arthritis, Hashimoto's Disease, Sjogren's Disease, Lupus, Multiple Sclerosis

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Tai Chi
32 1-hour group sessions of Tai Chi instruction
Behavioral: Tai Chi
32 1-hour bi-weekly group sessions of Tai Chi instruction
ACTIVE_COMPARATOR: Resistance Band
32 1-hour bi-weekly group sessions of Resistance Band exercises
Behavioral: Resistance Band
32 1-hour bi-weekly group sessions of Resistance Band exercises
PLACEBO_COMPARATOR: Health Education
32 1-hour bi-weekly group sessions of health education
Behavioral: Health Education
32 1-hour bi-weekly group sessions of health education
NO_INTERVENTION: Care as Usual
Receive usual cardiology care for 4 months between pre- and post-treatment testing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Left Ventricular Ejection Fraction (%LVEF)
Time Frame: Change from Baseline in %LVEF Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in cardiac functional capacity as measured by %LVEF on echocardiogram.
Change from Baseline in %LVEF Immediately Following 16 Weeks of Treatment
End Systolic Volume (ESV)
Time Frame: Change from Baseline in ESV Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in cardiac functional capacity as measured by ESV on echocardiogram.
Change from Baseline in ESV Immediately Following 16 Weeks of Treatment
End Diastolic Volume (EDV)
Time Frame: Change from Baseline in EDV Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in cardiac functional capacity as measured by EDV on echocardiogram.
Change from Baseline in EDV Immediately Following 16 Weeks of Treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
B-type Natriuretic Peptide (BNP)
Time Frame: Change from Baseline in BNP Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in cardiac functional capacity as measured by serum levels of BNP.
Change from Baseline in BNP Immediately Following 16 Weeks of Treatment
Six-Minute Walk Task (6MWT)
Time Frame: Change from Baseline in 6MWT Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in cardiac functional capacity as measured by 6MWT at post-treatment.
Change from Baseline in 6MWT Immediately Following 16 Weeks of Treatment
Work Performed on Bicycle Ergometer Task (Watts)
Time Frame: Change from Baseline in Watts Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in cardiac functional capacity as measured by average watts on a mild, graded exercise task on a bicycle ergometer at post-treatment assessment.
Change from Baseline in Watts Immediately Following 16 Weeks of Treatment
Average Number of Steps Across 3 Days (Steps)
Time Frame: Change from Baseline in Steps Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in cardiac functional capacity as measured by the average number of steps measured using a pedometer over a 3 day period immediately following 16 weeks of treatment.
Change from Baseline in Steps Immediately Following 16 Weeks of Treatment
Beck Depression Inventory (BDI) at Post-Treatment
Time Frame: Change from Baseline in BDI Scores Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in depression scores as measured by the BDI immediately following 16 weeks of treatment.
Change from Baseline in BDI Scores Immediately Following 16 Weeks of Treatment
BDI at 8-Week Follow-Up
Time Frame: Change from Baseline in BDI scores at 8-week follow-up
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in depression scores as measured by the BDI at the 8-week follow-up assessment.
Change from Baseline in BDI scores at 8-week follow-up
BDI at 1-Year Follow-Up
Time Frame: Change from Baseline in BDI Scores at 1-year follow-up
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in depression scores as measured by the BDI at the 1-year follow-up assessment.
Change from Baseline in BDI Scores at 1-year follow-up
Pittsburgh Sleep Quality Inventory (PSQI) at Post-Treatment
Time Frame: Change from Baseline on the (PSQI) Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in sleep quality scores as measured by the PSQI immediately following 16 weeks of treatment.
Change from Baseline on the (PSQI) Immediately Following 16 Weeks of Treatment
PSQI at 8-Week Follow-Up
Time Frame: Change from Baseline in PSQI scores at 8-week follow-up
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in sleep quality scores as measured by the PSQI at the 8-week follow-up assessment.
Change from Baseline in PSQI scores at 8-week follow-up
PSQI at 1-Year Follow-Up
Time Frame: Change from Baseline in PSQI Scores at 1-year Follow-Up Assessment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in sleep quality scores as measured by the PSQI at the 1-year follow-up assessment.
Change from Baseline in PSQI Scores at 1-year Follow-Up Assessment
Multidimensional Fatigue Symptom Inventory (MFSI) at Post-Treatment
Time Frame: Change from Baseline in MFSI Scores Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in fatigue scores as measured by the MFSI immediately following 16 weeks of treatment.
Change from Baseline in MFSI Scores Immediately Following 16 Weeks of Treatment
MFSI at 8-Week Follow-Up
Time Frame: Change From Baseline in MFSI Scores at 8-week Follow-up Assessment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in fatigue scores as measured by the MFSI at the 8-week follow-up assessment.
Change From Baseline in MFSI Scores at 8-week Follow-up Assessment
MFSI at 1-Year Follow-Up
Time Frame: Change From Baseline in MFSI Scores at the 1-Year Follow-Up Assessment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in fatigue scores as measured by the MFSI at the 1-year follow-up assessment.
Change From Baseline in MFSI Scores at the 1-Year Follow-Up Assessment
Minnesota Living with Heart Failure Questionnaire (MLHFQ) at Post-Treatment
Time Frame: Change from Baseline in MLHFQ Scores Immediately Following 16 Weeks of Treatment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in health-related quality of life scores as measured by the MHLFQ immediately following 16 weeks of treatment.
Change from Baseline in MLHFQ Scores Immediately Following 16 Weeks of Treatment
MHLFQ at 8-Week Follow-Up
Time Frame: Change from Baseline in MHLFQ at 8-Week Follow-Up Assessment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in health-related quality of life scores scores as measured by the PSQI at the 8-week follow-up assessment.
Change from Baseline in MHLFQ at 8-Week Follow-Up Assessment
MHLFQ at 1-Year Follow-Up Assessment
Time Frame: Change from Baseline in MHLFQ Scores at 1-year Follow-Up Assessment
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in health-related quality of life scores as measured by the MHLFQ at the 1-year follow-up assessment.
Change from Baseline in MHLFQ Scores at 1-year Follow-Up Assessment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
San Diego Veterans Healthcare System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura S Redwine, PhD, University of California, San Diego

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01HL096784-01A2 (NIH)

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