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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

high frequency chest wall oscillation with vest system

Lung flute (OPEP)

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vest Airway Clearance System

Lung flute (OPEP)

Arm Description

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, 3 times per week twice a day

Outcomes

Primary Outcome Measures

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 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/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

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

Secondary Outcome Measures

Six-minute walk test

Six-minute walk test was carried out before and after interventions to determine the patient functional capacity

COPD assessment test (CAT

is a validated, short (8-item) and simple patient completed questionnaire

Full Information

NCT ID

NCT05591781

First Posted

October 14, 2022

Last Updated

October 19, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05591781

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 2022 (Anticipated)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vest Airway Clearance System

Arm Type

Experimental

Arm Description

Arm Title

Lung flute (OPEP)

Arm Type

Active Comparator

Arm Description

Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 3 times per week twice a day

Intervention Type

Device

Intervention Name(s)

high frequency chest wall oscillation with vest system

Intervention 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.

Intervention Type

Device

Intervention Name(s)

Lung flute (OPEP)

Intervention Description

. 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

Primary Outcome Measure Information:

Title

Forced vital capacity (FVC)

Description

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

Time Frame

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

Title

Forced expiratory volume in one second (FEV1)

Description

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

Time Frame

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

Title

FEV1/FVC ratio

Description

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

Time Frame

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

Title

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

Description

(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

Time Frame

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

Secondary Outcome Measure Information:

Title

Six-minute walk test

Description

Six-minute walk test was carried out before and after interventions to determine the patient functional capacity

Time Frame

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

Title

COPD assessment test (CAT

Description

is a validated, short (8-item) and simple patient completed questionnaire

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alaa El-Moatasem, lecturer

Phone

01006625054

alaamotasem@rocketmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Omnia Ahmed, Lecturer

Phone

01227805225

omsaeed@msa.edu.eg

Facility Information:

Facility Name

Cairo University

City

Cairo

ZIP/Postal Code

11432

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alaa El-Moatasem, lecturer

Phone

01006625054

alaamotasem@rocketmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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