Exploring Tai Chi as a Behavioral Intervention for Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- End Systolic Volume (ESV)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
End Systolic Volume (ESV)
时间窗: 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.
Left Ventricular Ejection Fraction (%LVEF)
时间窗: 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.
End Diastolic Volume (EDV)
时间窗: 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.
次要结局
- Beck Depression Inventory (BDI) at Post-Treatment(Change from Baseline in BDI Scores Immediately Following 16 Weeks of Treatment)
- Minnesota Living with Heart Failure Questionnaire (MLHFQ) at Post-Treatment(Change from Baseline in MLHFQ Scores Immediately Following 16 Weeks of Treatment)
- B-type Natriuretic Peptide (BNP)(Change from Baseline in BNP Immediately Following 16 Weeks of Treatment)
- Average Number of Steps Across 3 Days (Steps)(Change from Baseline in Steps Immediately Following 16 Weeks of Treatment)
- MFSI at 1-Year Follow-Up(Change From Baseline in MFSI Scores at the 1-Year Follow-Up Assessment)
- MHLFQ at 8-Week Follow-Up(Change from Baseline in MHLFQ at 8-Week Follow-Up Assessment)
- Six-Minute Walk Task (6MWT)(Change from Baseline in 6MWT Immediately Following 16 Weeks of Treatment)
- Work Performed on Bicycle Ergometer Task (Watts)(Change from Baseline in Watts Immediately Following 16 Weeks of Treatment)
- PSQI at 8-Week Follow-Up(Change from Baseline in PSQI scores at 8-week follow-up)
- MFSI at 8-Week Follow-Up(Change From Baseline in MFSI Scores at 8-week Follow-up Assessment)
- Pittsburgh Sleep Quality Inventory (PSQI) at Post-Treatment(Change from Baseline on the (PSQI) Immediately Following 16 Weeks of Treatment)
- BDI at 8-Week Follow-Up(Change from Baseline in BDI scores at 8-week follow-up)
- BDI at 1-Year Follow-Up(Change from Baseline in BDI Scores at 1-year follow-up)
- PSQI at 1-Year Follow-Up(Change from Baseline in PSQI Scores at 1-year Follow-Up Assessment)
- Multidimensional Fatigue Symptom Inventory (MFSI) at Post-Treatment(Change from Baseline in MFSI Scores Immediately Following 16 Weeks of Treatment)
- MHLFQ at 1-Year Follow-Up Assessment(Change from Baseline in MHLFQ Scores at 1-year Follow-Up Assessment)
研究者
Laura S. Redwine, PhD
Assistant Adjunct Professor
University of California, San Diego