Exploring Behavioral Interventions to Improve Heart Failure

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
San Diego Veterans Healthcare System
Information provided by (Responsible Party):
Laura S. Redwine, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01625819
First received: April 18, 2012
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Heart Failure
Behavioral: Tai Chi
Behavioral: Resistance Band
Behavioral: Health Education
Behavioral: Care as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Exploring Tai Chi as a Behavioral Intervention for Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Left Ventricular Ejection Fraction (%LVEF) [ Time Frame: Change from Baseline in %LVEF Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.

  • End Systolic Volume (ESV) [ Time Frame: Change from Baseline in ESV Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.

  • End Diastolic Volume (EDV) [ Time Frame: Change from Baseline in EDV Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • B-type Natriuretic Peptide (BNP) [ Time Frame: Change from Baseline in BNP Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.

  • Six-Minute Walk Task (6MWT) [ Time Frame: Change from Baseline in 6MWT Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.

  • Work Performed on Bicycle Ergometer Task (Watts) [ Time Frame: Change from Baseline in Watts Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.

  • Average Number of Steps Across 3 Days (Steps) [ Time Frame: Change from Baseline in Steps Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.

  • Beck Depression Inventory (BDI) at Post-Treatment [ Time Frame: Change from Baseline in BDI Scores Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.

  • BDI at 8-Week Follow-Up [ Time Frame: Change from Baseline in BDI scores at 8-week follow-up ] [ Designated as safety issue: No ]
    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.

  • BDI at 1-Year Follow-Up [ Time Frame: Change from Baseline in BDI Scores at 1-year follow-up ] [ Designated as safety issue: No ]
    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.

  • Pittsburgh Sleep Quality Inventory (PSQI) at Post-Treatment [ Time Frame: Change from Baseline on the (PSQI) Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.

  • PSQI at 8-Week Follow-Up [ Time Frame: Change from Baseline in PSQI scores at 8-week follow-up ] [ Designated as safety issue: No ]
    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.

  • PSQI at 1-Year Follow-Up [ Time Frame: Change from Baseline in PSQI Scores at 1-year Follow-Up Assessment ] [ Designated as safety issue: No ]
    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.

  • Multidimensional Fatigue Symptom Inventory (MFSI) at Post-Treatment [ Time Frame: Change from Baseline in MFSI Scores Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.

  • MFSI at 8-Week Follow-Up [ Time Frame: Change From Baseline in MFSI Scores at 8-week Follow-up Assessment ] [ Designated as safety issue: No ]
    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.

  • MFSI at 1-Year Follow-Up [ Time Frame: Change From Baseline in MFSI Scores at the 1-Year Follow-Up Assessment ] [ Designated as safety issue: No ]
    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.

  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) at Post-Treatment [ Time Frame: Change from Baseline in MLHFQ Scores Immediately Following 16 Weeks of Treatment ] [ Designated as safety issue: No ]
    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.

  • MHLFQ at 8-Week Follow-Up [ Time Frame: Change from Baseline in MHLFQ at 8-Week Follow-Up Assessment ] [ Designated as safety issue: No ]
    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.

  • MHLFQ at 1-Year Follow-Up Assessment [ Time Frame: Change from Baseline in MHLFQ Scores at 1-year Follow-Up Assessment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 280
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: Care as Usual
Participant receives usual care from cardiologist for ~4 months between pre- and post-treatment testing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625819

Locations
United States, California
University of Califoria, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
San Diego Veterans Healthcare System
Investigators
Principal Investigator: Laura S Redwine, PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: Laura S. Redwine, PhD, Assistant Adjunct Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01625819     History of Changes
Other Study ID Numbers: 1 R01 HL096784-01A2
Study First Received: April 18, 2012
Last Updated: June 19, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
Tai Chi

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014