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临床试验/NCT05591781
NCT05591781Unknown不适用

Efficacy of High Frequency Chest Wall Oscillations Versus Lung Flute in Chronic Obstructive Pulmonary Disease Postcovid

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Forced vital capacity (FVC)

研究概览

简要总结

COPD causes an acute deterioration of respiratory symptoms, particularly increased breathlessness and cough, and increased sputum volume and/or purulence. Worsening airflow limitation is associated with an increasing prevalence of exacerbations and risk of death. These exacerbations can range from self-limited diseases to episodes of florid respiratory failure requiring mechanical ventilation .Hospitalization for COPD patients post COVID is associated with poor prognosis with increased risk of death. Hence techniques of efficient clearance of peripheral airways may reduce airway occlusion by excess mucus and inflammatory cells, improving lung function, exercise capacity and reducing exacerbation frequency.

详细描述

Patients were assigned to 2 groups with pre- and post- treatment protocol application. All patients were thoroughly evaluated before and after treatment protocol application. Thirty patients (Group A) received high frequency chest wall oscillation with vest system in addition to their prescribed medication, 3 times per week for three successive weeks and the total duration of each session was 15-30 minutes. Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 2 times per week twice a day for three successive weeks and the total duration of each session was 10-15 minutes

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
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • All patients aged 40-60 years old
  • All patients were recovered from COVID not more than 3 months
  • All patients were diagnosed as COPD for at least two years ago.
  • All patients had irreversible/ partially reversible obstruction of airflow.
  • COPD patients had a post-bronchodilator, FEV1/FVC% < 70%. They had an increase in FEV1< 200 ml, or < 12% of baseline value 20 minutes after 2 puffs of inhaled salbutamol (100 µg) given via a metered-dose inhaler.

排除标准

  • Presence of malignant disease.
  • Patients with acute infection.
  • History of osteoporosis, significant gastro-oesophageal reflux, hiatus hernia.
  • Recent acute cardiac event (6 weeks) or congestive cardiac failure.
  • Any significant musculoskeletal disorders.

结局指标

主要结局

Forced vital capacity (FVC)

时间窗: Forced vital capacity (FVC)will be measured at baseline, and after three weeks.

FVC is the amount of air that can be forcibly exhaled from lungs after deepest inspiration, it's measured by spirometry

The forced mid-expiratory flow (FEF25-75%)

时间窗: (FEF25-75%) will be measured at baseline, and after three weeks.

(FEF25-75) measures the average flow rates of medium-to-small airways during the forced vital capacity (FVC).it' is a potentially sensitive marker of obstructive peripheral airflow

Forced expiratory volume in one second (FEV1)

时间窗: FEV1 will be measured at baseline, and after three weeks.

FEV1 is the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation

FEV1/FVC ratio

时间窗: FEV1/FVC ratio will be measured at baseline, and after three weeks.

The FEV1/FVC is a ratio that reflects the amount of air you can forcefully exhale from your lungs. It's measured by spirometry, a test used to evaluate lung function

次要结局

  • COPD assessment test (CAT(COPD assessment test (CAT)will be measured at baseline, and after three weeks.)
  • Six-minute walk test(6min walk test will be measured at baseline, and after three weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Mohamed El-Moatasem Mohamed

lecturer of physical therapy

Cairo University

研究点 (2)

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