The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Apnea hypopnea index
研究概览
简要总结
This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in patients with heart failure and obstructive sleep apnea syndrome.
详细描述
Patients with heart failure will be selected through the Outpatient of the Rio Grande do Sul, for convenience. Subsequently, patients will be subjected to test respiratory muscle strength (manometer), respiratory muscle endurance, portable polysomnography, sleepiness, sleep quality, cognitive function (mini-mental state examination), motor task (execution of a sequence of digital movements), executive function, quality of life (SF-36), maximum exercise testing, chemoreflex sensitivity (peripheral chemoreflex by transient hypoxia and central chemoreflex by hypercapnic hyperoxia) and vagal modulation of heart rate (spectral analysis) before the start of the training protocol. Patients will be randomized to inspiratory muscle training or control group. Inspiratory muscle training will be performed for 30 minutes a day, 7 days a week, for 12 weeks with muscle training device (PowerBreathe). There will be a weekly monitoring in the Clinical Research Center of the institution where the maximal inspiratory pressure (MIP) and respiratory training techniques will be reassessed and readjusted (30% of MIP). The control group will be submitted to respiratory training techniques with muscle training device (PowerBreathe) without load. After this period, all initial tests will be reassessed. A group study with 15 heart failure patients without obstructive sleep apnea syndrome will be included.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure patients with obstructive sleep apnea- hypopnea
- •Heart failure patients without sleep apnea
- •Left ventricle fraction ejection < 51 % for men and < 53% for woman
- •Must be clinically stable
- •New York Heart Association I, II and III
- •Without changes in medication for the last three months.
排除标准
- •Unstable angina
- •Atrial fibrillation
- •Acute myocardial infarction (<6 months)
- •Recent heart surgery (<6 months)
- •Chronic metabolic disease
- •Infectious disease
- •Severe hypoxemia
- •Neuromuscular disease
- •Diabetes mellitus
- •Use of continuous positive airway pressure
- •Pulmonary disease (forced vital capacity <80% of predicted and / or forced expiratory volume in one second <70% predicted).
结局指标
主要结局
Apnea hypopnea index
时间窗: 12 weeks
measured by portable polysomnography \[in events/hour\]
次要结局
- sleepiness(12 weeks)
- sleep quality(12 weeks)
- cognitive function(12 weeks)
- motor task(12 weeks)
- executive function measured by Trail Making Test(12 weeks)
- quality of life assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)(12 weeks)
- peak oxygen consumption(12 weeks)
- chemoreflex sensitivity(12 weeks)
- vagal modulation measured by heart rate monitoring in the time domain (spectral analysis)(12 weeks)