Effect of Breather Trainer Versus Pulmonary Rehabilitation on Cardiopulmonary Efficiency in Patients With COPD Post COVID-19
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of change in Physical Fitness Index (PFI)
研究概览
简要总结
The purpose of the study is to determine the difference between The Breather respiratory muscle trainer and pulmonary rehabilitation in patients with COPD post COVID-19.
详细描述
The main concern in post COVID-19 patients is the involvement of respiratory system and cardiovascular system which may result in dyspnea, low blood oxygen saturation, and decrease cardiopulmonary efficiency.
In cases of post COVID-19 patients with COPD their state is deconditioned and more critical than normal to be either in the zone of progression or regression or stability as the studies showed that handling of these cases during (3-6 months post-COVID) will prevent these symptoms from becoming permanent.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Their age ranges from 30-40 years old.
- •COPD patients GOLD1 (Mild FEV1≥80% predicted) and GOLD2 (Moderate 50% ≤FEV1<80%predicted) (Manian, 2019)
- •patients diagnosed as post COVID-19 Pneumonia between 3 and 6 Months ago with CT scan and PCR testing.
- •Their body mass index (BMI) ranged from 20 to 29.9kg/m
- •Stable medical cases with dyspnea
排除标准
- •Patients who will meet one of the following criteria will be excluded from the study:
- •patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure.
- •Sever cases of COPD (FEV1/FVC< 50%)
- •Mitral or aortic valvular disease, pericardial effusion.
- •Recent myocardial infarction.
结局指标
主要结局
Assessment of change in Physical Fitness Index (PFI)
时间窗: at baseline and 3 months of intervention
To assess the change in Physical Fitness Index (PFI) By using Modified Harvard Step Test (HST): The test will be done on a step height of 33 cm height. PFI was calculated by using following formula
Assessment of change in Forced vital capacity
时间窗: at baseline and 3 months of intervention
To assess the change in Forced vital capacity (FVC) by spirometry. The unit of measure is liters.
Assessment of change in Forced expiratory volume in the first one second
时间窗: at baseline and 3 months of intervention
To assess the change in Forced expiratory volume in the first one second (FEV1) by spirometry. The unit of measure is liters.
Assessment of change in Forced expiratory volume in the first one second expressed as percentage of the predicted FEV1
时间窗: at baseline and 3 months of intervention
To assess the change in the Forced expiratory volume in the first one second expressed as a percentage of the predicted FEV1 (FEV1%) by spirometry. The unit of measure is the liters.
Assessment of change in Rate Pressure Product
时间窗: at baseline and 3 months of intervention
To assess the change in Rate Pressure Product. First, the baseline heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be recorded, by an aneroid sphygmomanometer. HR will be constantly displayed on pulse oximetry. The rate-pressure product (RPP) = HR X SBP
Assessment of change in Maximum voluntry ventilation
时间窗: at baseline and 3 months of intervention
To assess the change in the maximum voluntary ventilation (MVV) by spirometry. The unit of measure is the liters/ minute.
Assessment of change in Ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs
时间窗: at baseline and 3 months of intervention
To assess the change in the ratio of forced expiratory volume in the first one second to the forced vital capacity of lungs (FEV1/FVC) by spirometry. The unit of measure is the ratio.
Assessment of change in Forced vital capacity expressed as percentage of the predicted FVC
时间窗: at baseline and 3 months of intervention
To assess the change in the Forced vital capacity expressed as a percentage of the predicted FVC (FVC%) by spirometry. The unit of measure is the liters.
次要结局
- Assessment of change in Oxygen saturation(at baseline and 3 months of intervention)
研究者
Eman Rashad Ali Elsayed
Principal investigator
Horus University