Effect of Tai Chi Program on Cardiac Functions and Quality of Life in Patients With Heart Failure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Pro-BNP levels (pg/ml)
研究概览
简要总结
Aim: The aim of the present study is to examine with B-type natriuretic peptide (pro-BNP) and echocardiographic parameters and to measure life quality the effects of the 12-week Tai-Chi exercise program on cardiovascular responses in patients with heart failure in Turkey. In addition, four basic research questions have been identified for the purpose of the research:
Methods:Randomized controlled trial will be carried out in the cardiology outpatient clinic in Turkey. The research will include two groups, an intervention (n=23) and a control (n=23). Cardiovascular responses will be measured with Pro-BNP, transthoracic echocardiography and six minutes walking test; Quality of life measurements with Left Ventricular Dysfunction Scale (LVD-36).Tai-Chi exercises will be carried out for a total of 12 weeks, with 2 sessions each week and one hour each session for intervention group. In addition, initially, approximately 45 minutes of heart failure education will be given to both the intervention and control groups.
详细描述
The aim of the present study is to examine with B-type natriuretic peptide (pro-BNP) and echocardiographic parameters and to measure life quality the effects of the 12-week Tai-Chi exercise program on cardiovascular responses in patients with heart failure in Turkey. In addition, four basic research questions have been identified for the purpose of the research:
- Methods:
1.1. Design: Randomized controlled trial. 1.2. Setting: The research will be carried out in the cardiology outpatient clinic of Izzet Baysal Training and Research Hospital, Bolu, Turkey.
1.3. Sample: The research will include two groups, an intervention and a control. Power analysis was used to determine the sample size. The sample of 46 (intervention=23, control=23) was sufficient with 0.86 effect size, 95% confidence interval and 80% power. In randomization, closed envelope method will be used.
1.4. Data collecting
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
- Double (Participant, Care Provider)
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
- •18 years and over,
- •Diagnosed as chronic heart failure by the physician,
- •Left ventricular ejection fraction (LVEF) <40%, proven by echocardiography in the past two years,
- •New York Heart Association (NYHA) class II and III,
- •Sinus rhythm is observed in electrocardiography (ECG),
- •Blood pressure values measured before Tai Chi session were 120-160 mmHg for systolic pressure and 80-110 mmHg for diastolic pressure,
- •No current anxiolytic or hypnotic treatment,
- •Have no psychiatric problems,
- •Verbal communication can be established,
- •Those who understand and speak Turkish,
- •No speech, hearing and vision loss,
- •There is no physical limitation that prevents the exercise of standing,
- •They have never experienced Tai Chi exercise before,
- •Individuals who volunteer to participate in the Tai Chi program during the study
排除标准
- •Having unstable angina pectoris, myocardial infarction or major cardiac surgery in the past three months,
- •Experiencing dyspnea and exercise tolerance that worsen during rest,
- •NYHA class I and IV,
- •Type B natriuretic peptide level measured in the last three months is 100 and above,
- •Blood pressure values measured before the Tai Chi session are> 120 mmHg or <160 mmHg for systolic pressure and> 80 mmHg or <110 mmHg for diastolic pressure,
- •Has hemodynamically significant heart valve disease,
- •Having dysrhythmia problems such as ventricular tachyarrhythmia, atrial fibrillation,
- •Has a history of cardiac resynchronization therapy in the past 3 months,
- •Having chronic diseases such as chronic pulmonary disease and renal failure,
- •With uncontrolled diabetes (Hemoglobin A1C ≥ 7 mg / dl),
- •Diagnosed with thrombophlebitis,
- •Has a history of cardiac transplantation and cardiac device therapy (cardiac pacemaker, implantable cardioverter defibrillator),
- •Having physical limitations that prevent standing exercise,
- •Do not understand and speak Turkish,
- •Speech, hearing and vision loss,
- •Individuals who do not volunteer to participate in the Tai Chi program during the study
结局指标
主要结局
Pro-BNP levels (pg/ml)
时间窗: 3-months
Biomarker to be used to estimate the prognosis of heart failure. The blood taken into 2ml EDTA tubes will be studied.
Transthoracic Echocardiography measurements
时间窗: 3-months
Transthoracic echocardiography will be performed to each individual and multiple criteria will be evaluated.In two-dimensional echocardiographic examination, left ventricular ejection fraction will be evaluated by M-mod and Simpson methods.
次要结局
- Six-minute walking test (meter)(3-months)
- Quality of life(3-months)
研究者
Seyma Demir
Research Assist
Abant Izzet Baysal University