Effect of Exercise Training in Patients With Heart Failure and Permanent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Functional Capacity Assessement
研究概览
简要总结
The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical condition of the patients more compromised.
详细描述
The positive effect of physical training in patients with heart failure (HF) has been increasingly established. However, the presence of atrial fibrillation (AF), mainly in its permanent form, makes the clinical picture of these patients more compromised. The literature has not yet demonstrated studies involving indication of physical exercise therapy when AF is associated with HF. Thus, the hypothesis is that physical training improves functional capacity, cerebral oxygenation, autonomic aspects, vascular aspects, cardiac function, plasma markers, quality of life and cognitive function of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with clinically stable NYHA class II to III heart failure with permanent atrial fibrillation (AF);
- •Left ventricular ejection fraction ≤40%;
- •Patients refractory and / or no indication of the treatment of reversal to the rhythm;
- •Patients in optimization specific drug therapy for HF and AF.
排除标准
- •High-frequency ventricular response;
- •Neuromuscular / neuropathy disease;
- •Physical and mental impairment;
- •Chronic obstructive pulmonary disease;
- •Diabetes mellitus;
- •Decompensated arterial hypertension;
- •Autonomic neuropathy;
- •Recent myocardial infarction (<6 months);
- •Ventricular arrhythmias;
- •Atrial flutter;
- •Renal failure;
- •Use implantable electronic cardiac device or indication for implantation;
- •Pregnancy;
- •NYHA Functional Class IV;
- •Resting heart rate <55 bpm;
- •Wolff Parkinson White Syndrome;
- •Thyroid dysfunction;
- •Unstable angina;
- •Recent history of thromboembolic event;
- •Inability to sign the consent form;
- •Participation in regular physical training program;
- •Use of alcoholic beverages.
研究组 & 干预措施
Control Group
Patients in the group who are continuously guided as the activities of daily living normally avoiding participation in any regular program of physical exercise does not proceed from the study.
Training Group
the patients randomized to the physical training group will undergo the supervised physical training program
干预措施: Physical Training (Behavioral)
结局指标
主要结局
Functional Capacity Assessement
时间窗: two year
unctional function is assessed by measuring oxygen consumption (VO2). Multidimensional electrocardiography logo will be connected to a computerized system through a remote and tracheal control system. Through Oxygen Detergent (O2) and carbon dioxide (CO2) the concentrations of O2 and CO2, respectively, are analyzed for each respiratory cycle.
次要结局
- Muscle Sympathetic Nervous Activity Assessment(Two year)
- Measurement of Muscle Blood Flow(Two year)
- Evaluation of endothelium-dependent vascular function(Two year)
- Evaluation of neurovascular control during mental stress(Two)
- Evaluation of the concentration of plasma biomarkers(Two year)
- Assessment of cognitive function(Two year)
- Evaluation of cardiac structure and function(Two year)
- Quality of life assessment(Two year)
- Measurement of Pulse Wave Velocity (PWV)(Two year)