Effects of Continuous and Bilevel Positive Airway Pressure During Exercise-induced Bronchoconstriction in Asthmatic Children: Controlled Clinical Trial, Randomized
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Exhaled nitric oxide (part per billion)
研究概览
简要总结
Asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness and chronic airway inflammation and pharmacological treatment for this condition is done with bronchodilators and anti-inflammatory.
详细描述
Pharmacologic therapy has clinical efficacy in the control, but the patient often does not adhere adequately.
There is need for further research into non-pharmacological therapies for clinical asthma control and in turn the use of CPAP and bilevel pressure in the airways has shown beneficial effects on autonomic modulation and bronchial responsiveness leading to the hypothesis that these therapies also have effects on the BIE.The aim of this study is to evaluate the effect of these non-pharmacological therapies in several variables and especially the BIE.
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
- None
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 5:11 years;
- •Both sexes;
- •Do not be included in any regular physical activity program;
- •Having a diagnosis of asthma, according to the Global Initiative for Asthma (GINA);
- •Not having received Theophylline or aminophylline and oral corticosteroids in the last 30 days;
- •not have presented respiratory infection in the last two months;
- •Signature of IC
排除标准
- •Have done inhaled bronchodilator in less than 12 hours before the assessment;
- •Inability to understand or perform any of the tests, due to physical and mental limitations;
- •Intolerance proposed activities;
- •Have heart disease inflammatory, congenital or ischemic origin;
- •Being in the presence of any infectious process with fever.
研究组 & 干预措施
muscle training
participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions
干预措施: muscle training (Device)
muscle training
participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions
干预措施: Continue Positive Airway Pressure (Device)
muscle training
participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions
干预措施: bilevel positive airway pressure (Device)
bilevel positive airway pressure
participants will breathing exercises for 20 min, then 40 min bilevel (IPAP and EPAP 12 = 8 cm H2O), the therapy will be held in 7 sessions
干预措施: muscle training (Device)
bilevel positive airway pressure
participants will breathing exercises for 20 min, then 40 min bilevel (IPAP and EPAP 12 = 8 cm H2O), the therapy will be held in 7 sessions
干预措施: Continue Positive Airway Pressure (Device)
bilevel positive airway pressure
participants will breathing exercises for 20 min, then 40 min bilevel (IPAP and EPAP 12 = 8 cm H2O), the therapy will be held in 7 sessions
干预措施: bilevel positive airway pressure (Device)
Continue Positive Airway Pressure
participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions
干预措施: muscle training (Device)
Continue Positive Airway Pressure
participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions
干预措施: Continue Positive Airway Pressure (Device)
Continue Positive Airway Pressure
participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions
干预措施: bilevel positive airway pressure (Device)
结局指标
主要结局
Exhaled nitric oxide (part per billion)
时间窗: 5 minutes
assess the degree of inflammation of the respiratory system using expired fraction of nitric oxide before and after the different protocols applied
次要结局
- Bronchoconstriction induced by stress(30 minutes)
- Heart Rate Variability(20 minutes)
- Pulmonary function test(20 minutes)
- manovacuometry(10 minutes)
- bioelectrical impedance(10 minutes)
研究者
Daysi Tobelem
Md
University of Nove de Julho