Prospective Aleatory Study of Non Invasive Mechanical Ventilation Versus Respiratory Rehabilitation in Hypercapnic Stable Severe COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- exercise capacity
研究概览
简要总结
Objective: To analyze the additional benefits of exercise training application by the non-invasive home mechanical ventilation in patients with stable COPD and hypercapnic respiratory failure. SUBJECT: moderate-severe COPD (FEV1 <60%) in chronic respiratory failure (hypoxemia and hypercapnia PaCO2> 45mmHg). GROUPS: 45 patients included prospectively and randomly into 3 groups of 15: a) training + NIPPV group, b) Group training, c) Group NIPPV. Hypothesis: A training program to the effort associated with treatment with NIPPV significantly increase the effects compared with each treatment. MAIN OBJETIVE: Effects on exercise capacity as measured by the test of endurance cycling and test 6-minute walk (distance). SECONDARY OBJECTIVES: Impact on quality of life and dyspnea, as measured by questionnaire and CRQ, systemic inflammatory response (CRP, IL-8, TNF-α), changes in peripheral muscle strength (1RM test, isometric) and effects score BODE index.
详细描述
- POPULATION: Patients with COPD diagnosed according to criteria established by the ATS (American Thoracic Society) and the SEPAR (Spanish Society of Pneumology and Thoracic Surgery) to submit a modereda-severe obstruction to airflow (FEV1 <60%) and a clinical impact of their disease. Patients must have chronic respiratory failure with hypoxemia and hypercapnia (PaCO2> 45 mmHg). Patients should be stable and appropriate therapy.
- SAMPLE: 45 patients diagnosed at the Department of Pulmonology, Hospital Virgen del Rocío de Sevilla, informed consent.
- EXCLUSION CRITERIA a. Other cardiorespiratory diseases. b. Systemic diseases c. Disability or discomfort to participate in an exercise program or noninvasive ventilation
- STUDY GROUP: The patients were prospectively included and randomized to one of three groups of 15 patients:
- Group exercise training program of positive pressure ventilation and noninvasive.
- Group exercise training program.
- Group program Ventilation Noninvasive positive pressure.
- Variables: All patients underwent the following baseline tests:
• CXR, elementary analysis, 12-lead electrocardiogram
• simple spirometry and bronchodilator test
• Blood gases
- static lung volumes (FRC, RV, TLC) by plethysmography.
- Study of diffusion (DLCO) by single breath technique
- maximum muscle pressures both inspiratory and expiratory.
- Estimation of muscle strength:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with COPD (Chronic Obstructive Pulmonary Disease)
- •airflow obstruction with an FEV1 <60%
- •clinical stability, at least last 3 months
- •Chronic respiratory failure with hypoxemia and hypercapnia (PaCO2> 45 mmHg)
排除标准
- •Presence of musculoskeletal condition that limits or prevents the completion of the exercises.
- •Presence of heart disease that prevents the physical exercise.
- •Patients with bronchiectasis or other respiratory disorder other than COPD
- •inability or discomfort to participate in the exercise or non-invasive ventilation
结局指标
主要结局
exercise capacity
时间窗: baseline and end of follow-up period (15 weeks)
Our primary objective is to verify the beneficial effect on exercise capacity of an exercise training program combined with treatment of positive pressure ventilation noninvasive against each of them separately, in patients with COPD. The improvement in exercise capacity will be assessed by increased resistance time (submaximal exercise test) and distance (test 6-minute walk)
次要结局
- Peripheral muscle strength(baseline and end of follow-up period (15 weeks))
- quality of life(baseline and end of follow-up period (15 weeks))
- inflammation(baseline and end of follow-up period (15 weeks))
- BODE(baseline and end of follow-up period (15 weeks))