Effect of PEP Buddy During Aerobic Training on Breathing, Exercise, and Sleep Quality in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- dyspnea
研究概览
简要总结
Exercise intolerance and sleeping problems are among the most common symptoms experienced by patients with chronic obstructive pulmonary disease (COPD), which is associated with lung dynamic hyperinflation (DH). There was evidence that positive expiratory pressure (PEP), which less costly devices could offer, could reduce DH.
A positive expiratory pressure device improved COPD-related symptoms in more than 70% of patients with COPD.
PEP buddy is an adjunct to current COPD therapies, such as inhalers and pulmonary rehabilitation. It provides a tool for self-management and breathing re-training, reducing dyspnea and improving quality of life.
详细描述
PEP devices have been wildly used to reduce breathing frequency and expiratory flow limitation, change breathing patterns, improve gas exchange, as well as result in less airway collapse and air-trapping in patients with COPD.
Increasing COPD disease severity promotes a negative impact on exercise tolerance and magnifies the level of disability. Physical activity programs appear to safely ameliorate these COPD consequences, conferring beneficial effects on dyspnea and health-related quality of life.
The combination of PEP during aerobic exercise helps to get the most benefits from the exercise for a longer time and little dyspnea and fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• All gender COPD patients
- •Age will be 55-65 years.
- •Moderate to severe COPD patients
- •emphysema on CT scan (HU ≥ - 900)
- •Their FEV1 will be less than 80% predicted
- •Class II obesity (BMI of 35 to < 40)
- •Medically stable
- •greater than 10 pack-year smoking history
排除标准
- •• Very severe COPD - Lung cancer
- •Lung resection - Lung fibrosis
- •Heart failure - Cognitive disorders that affect the device application
- •Musculoskeletal or neurological disorders that interfere with an exercise program
- •requiring invasive or non-invasive positive pressure ventilation
- •inability to speak in complete sentences due to breathlessness
- •suspected elevated intracranial pressure - hemodynamic instability
- •recent facial, oral, or skull surgery
- •active hemoptysis (more than two tablespoons of frank blood per day)
- •pneumothorax - failure to comply with the research protocol.
- •uncontrolled hypertension, or other concomitant respiratory diseases
- •participate in any research or pulmonary rehabilitation program during the period of this study.
- •imaging changes of lung disease such as occupancy, exudation, and interstitial changes on CT scan
结局指标
主要结局
dyspnea
时间窗: baseline and after 8 weeks
it will be evaluated by mMRC dyspnea scale. it is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing
次要结局
- exercise capacity(baseline and after 8 weeks)
- Sleep quality(baseline and after 8 weeks)
- pulmonary function(baseline and after 8 weeks)
- Health-related quality of life (HRQoL)(baseline and after 8 weeks)
研究者
Ebtesam Nabil
lecturer at Physical Therapy Department for Cardiovascular/Respiratory Disorder and Geriartics
Cairo University