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

NCT05591781 | Unknown FDA Device

• 1 other identifier: P.T.REC/012/003822
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Six-minute walk test

  6min walk test will be measured at baseline, and after three weeks.

• COPD assessment test (CAT

  COPD assessment test (CAT)will be measured at baseline, and after three weeks.

Study Arms (2)

Vest Airway Clearance System

EXPERIMENTAL

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

Lung flute (OPEP)

ACTIVE COMPARATOR

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)

Interventions

high frequency chest wall oscillation with vest system DEVICE

Patients were assigned to 2 groups with pre- and post- treatment protocol application. All patients were thoroughly evaluated before and after treatment protocol application.

Vest Airway Clearance System

Lung flute (OPEP) DEVICE

. 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

Lung flute (OPEP)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Central Study Contacts

Alaa El-Moatasem, lecturer

CONTACT

01006625054; alaamotasem@rocketmail.com

Omnia Ahmed, Lecturer

CONTACT

01227805225; omsaeed@msa.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of physical therapy

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 24, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-06

Locations

EG (1)