Clinical trial NCT05591781: High Frequency Chest Wall Oscillations Versus Lung Flute in Chronic Obstructive Pulmonary Disease Post(SARS-CoV-2)
Official title: Efficacy of High Frequency Chest Wall Oscillations Versus Lung Flute in Chronic Obstructive Pulmonary Disease Postcovid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: Forced vital capacity (FVC)will be measured at baseline, and after three weeks.
measure: Forced expiratory volume in one second (FEV1)
timeFrame: FEV1 will be measured at baseline, and after three weeks.
measure: FEV1/FVC ratio
timeFrame: FEV1/FVC ratio will be measured at baseline, and after three weeks.
measure: The forced mid-expiratory flow (FEF25-75%)
timeFrame: (FEF25-75%) will be measured at baseline, and after three weeks.
Secondary outcomes:
measure: Six-minute walk test
timeFrame: 6min walk test will be measured at baseline, and after three weeks.
measure: COPD assessment test (CAT
timeFrame: COPD assessment test (CAT)will be measured at baseline, and after three weeks.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: