Exploring Behavioral Interventions to Improve Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Exploring Tai Chi as a Behavioral Intervention for Heart Failure Patients

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Tai Chi
* Behavioral: Resistance Band
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi<br>32 1-hour group sessions of Tai Chi instruction | Behavioral: Tai Chi<br>* 32 1-hour bi-weekly group sessions of Tai Chi instruction<br>|
| Active Comparator: Resistance Band<br>32 1-hour bi-weekly group sessions of Resistance Band exercises | Behavioral: Resistance Band<br>* 32 1-hour bi-weekly group sessions of Resistance Band exercises<br>|
| Placebo Comparator: Health Education<br>32 1-hour bi-weekly group sessions of health education | Behavioral: Health Education<br>* 32 1-hour bi-weekly group sessions of health education<br>|
| No Intervention: Care as Usual<br>Receive usual cardiology care for 4 months between pre- and post-treatment testing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction (%LVEF) | 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) | 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) | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B-type Natriuretic Peptide (BNP) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tai Chi