High Frequency Chest Wall Oscillations Versus Lung Flute in Chronic Obstructive Pulmonary Disease Post(SARS-CoV-2)

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: high frequency chest wall oscillation with vest system
* Device: Lung flute (OPEP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vest Airway Clearance System<br>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 | Device: high frequency chest wall oscillation with vest system<br>* Patients were assigned to 2 groups with pre- and post- treatment protocol application. All patients were thoroughly evaluated before and after treatment protocol application.<br>|
| Active Comparator: Lung flute (OPEP)<br>Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 3 times per week twice a day | Device: Lung flute (OPEP)<br>* . Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 3 times per week twice a day for three successive weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced vital capacity (FVC) | FVC is the amount of air that can be forcibly exhaled from lungs after deepest inspiration, it's measured by spirometry | Forced vital capacity (FVC)will be measured at baseline, and after three weeks. | 
| Forced expiratory volume in one second (FEV1) | FEV1 is the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation | FEV1 will be measured at baseline, and after three weeks. | 
| FEV1/FVC ratio | 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 | FEV1/FVC ratio will be measured at baseline, and after three weeks. | 
| The forced mid-expiratory flow (FEF25-75%) | (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 | (FEF25-75%) will be measured at baseline, and after three weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk test | Six-minute walk test was carried out before and after interventions to determine the patient functional capacity | 6min walk test will be measured at baseline, and after three weeks. | 
| COPD assessment test (CAT | is a validated, short (8-item) and simple patient completed questionnaire | COPD assessment test (CAT)will be measured at baseline, and after three weeks. |