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Completed

NCT Number: NCT01625819

Exploring Behavioral Interventions to Improve Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Califoria, San Diego

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Symptoms of chronic heart failure for at least 3 months.
  • 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.
  • ACC/AHA stages B and C
  • Ability to perform light to moderate exercise (NYHA functional class II and III)
  • Presence of HF with an ejection fraction less than 40%, or diastolic dysfunction
  • Ability to give informed consent
  • At least18 years of age

Exclusion criteria

  • History of recent myocardial infarction (1 month)
  • Angina not adequately managed with nitrates.
  • Aortic or mitral stenosis
  • Coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 6 months.
  • Severe COPD
  • Recent stroke or significant cerebral neurologic impairment.
  • Active Suicidality
  • Currently participating in an exercise program.
  • Currently taking mood stabilizers (e.g. lithium), benzodiazepines or antipsychotics.
  • 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

Treatment and study plan

Tai Chi

Behavioral

32 1-hour bi-weekly group sessions of Tai Chi instruction

Resistance Band

Behavioral

32 1-hour bi-weekly group sessions of Resistance Band exercises

Health Education

Behavioral

32 1-hour bi-weekly group sessions of health education

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • San Diego Veterans Healthcare System

Registry information

Official study title

Exploring Tai Chi as a Behavioral Intervention for Heart Failure Patients

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jun 21, 2012
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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