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临床试验/NCT02122848
NCT02122848已完成不适用

Effects of Bilevel Positive Airway Pressure on Exercise Tolerance in Patients With Decompensated Heart Failure

Hospital Sirio-Libanes2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Endurance time of exercise in cycle ergometer.

研究概览

简要总结

The purpose of this study is to evaluate the effects of airway bilevel positive pressure on the improvement of exercise tolerance in patients with decompensated heart failure.

详细描述

Heart failure causes limitation of functional capacity and worsening of exercise tolerance. The airway pressure as adjuvant of cardiac rehabilitation has demonstrated improvement of functional capacity, decrease of respiratory work, increase of oxygenation and pulmonary compliance. Objective: to evaluate the effectiveness of the bilevel positive airway pressure (BILEVEL) in the increase of exercise tolerance in patients with decompensated heart failure. Method: this is a cross-over randomized clinical trial, with individuals who will undergo a submaximal progressive exercise test of the lower limbs with a cycle-ergometer using continuous positive airway pressure (CPAP) and BILEVEL in a random order. Patients will also be evaluated using a health related quality of life questionnaire, pulmonary function test, inspiratory muscle and peripheral muscle strength tests. Hypothesis: The increase in exercise tolerance might be greater during the use of BILEVEL.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects who has heart failure functional class II or III of New York heart association
  • over 18 years
  • non-smokers
  • without cognitive or motor deficit
  • without vasoactive drugs or low doses
  • without recent acute myocardial myocardium (<1 year)
  • without recent cardiac surgery (<1 year)
  • without pulmonary disease
  • without bronchodilators

排除标准

  • unstable angina
  • atrial fibrillation and atrioventricular block third degree
  • frequent vomiting
  • respiratory instability while collecting data

结局指标

主要结局

Endurance time of exercise in cycle ergometer.

时间窗: 4 days

次要结局

  • Dyspnea(4 days)

研究者

发起方
Hospital Sirio-Libanes
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wellington Yamaguti

Wellington Pereira dos Santos Yamaguti

Hospital Sirio-Libanes

研究点 (2)

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