Comparison Between Exercise Training and CPAP Treatment for Patients With Heart Failure and Sleep Apnea.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Polysomnography
研究概览
简要总结
Introduction. Heart failure is the result of primary ventricular dysfunction followed by neurohormorais changes, distribution of cardiac output, peripheral circulation, the skeletal and respiratory muscles, which determine their clinical and prognosis. Despite the advancement in treatment, morbidity and mortality remain high. Physical training appears as a therapeutic strategy, because most of its beneficial effects is by inducing changes in peripheral physiological changes resulting from heart failure. Associated factors that may contribute to its progression and worse prognosis, now beginning to be studied, such as sleep apnea, the diagnosis provides important prognostic information and a potential therapeutic option for these patients.
Objectives. Demonstrate the benefits of physical training for patients with heart failure and sleep apnea, and compare treatment with CPAP alone and associated with the exercise program. Will also be assessed risk and adherence to physical training.
Material and Methods. The design will be prospective, longitudinal, randomized consecutive patients. After screening and baseline evaluations the patients will be randomized into Group 1 (CPAP, n = 20), Group 2 (CPAP + Physical training, n = 20), Group 3 (Physical Training, n = 20) and Group 4 (Control without intervention, n = 20). Outcomes (baseline and 3 months): Quality of sleep (polysomnography), Quality of life (Minnesota and SF-36), sexual function (QS-M and QS-F) and functional capacity (cardiopulmonary exercise testing and isokinetic testing). Physical training: aerobic and resistance exercises three times a week for three months. CPAP therapy:after polysomnography for titration with ventilator servo-assisted, and outpatient follow monthly, for three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 20-70 years
- •New York Heart Association Class II-III
- •Clinically stable for one month
- •Ejection fraction <40%
- •Peak VO2 <20 ml/kg/min
- •Stable and optimized medical therapy at least one month before the study
- •B-blocker therapy
- •Clinical and polysomnographic diagnosis of sleep apnea (IAH>10)
排除标准
- •Patients with previous treatment of sleep apnea
- •New York Heart Association Class IV
- •Clinical instability
- •Poor adherence to drug treatment
- •Myocardial infarction or revascularization within the past two months
- •Unstable angina
- •Symptomatic arrhythmias (pacemaker and defibrillator)
- •Obstructive aortic or mitral valvular disease
- •Hypertrophic cardiomyopathy
- •Abnormal exercise testing
- •Pulmonary arterial pressure >50mmHg
- •Chronic obstructive pulmonary disease
- •Intermittent leg claudication
- •Musculoskeletal disorders or psychiatric disease that prevents the patient from understanding and following the exercise prescription safely
结局指标
主要结局
Polysomnography
时间窗: Two evaluations (baseline and 3 month)
To evaluate changes from Baseline in quality of sleep, mainly sleep apnea, after 3 months. Overnight polysomnography will be perform using a digital system with 17 channels(EMBLA, Medicare Medical Devices). The following variables will be monitor: electroencephalogram, electrooculogram, electromyogram, electrocardiogram,snoring and body position. Airflow will be monitor using a thermocouple and pressure transducer. Chest and abdominal piezo-sensors will monitor respiratory effort. Arterial oxygen saturation and pulse will be record with a pulse oxymeter.
次要结局
- Cardiopulmonary exercise testing(Two evaluations (baseline and 3 month))
- Isokinetic strength and endurance(Two evaluations (baseline and 3 month))
- Quality of Life(Two evaluations (baseline and 3 month))
- Sexual Function(Two evaluations (baseline and 3 month))
研究者
Prof. Dr. Lia Azeredo-Bittencourt
Associate Professor
Associação Fundo de Incentivo à Pesquisa