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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591781
• Other study ID #: P.T.REC/012/003822
• Status: Recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: Cairo University
• Contact: Alaa El-Moatasem, lecturer
• Phone: 01006625054
• Email: alaamotasem[@]rocketmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• high frequency chest wall oscillation with vest system
Patients were assigned to 2 groups with pre- and post- treatment protocol application. All patients were thoroughly evaluated before and after treatment protocol application.
• Lung flute (OPEP)
. 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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.