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

NCT ID: NCT05591781

Last Updated: 2022-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2022-12-31

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

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vest Airway Clearance System

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

Group Type EXPERIMENTAL

high frequency chest wall oscillation with vest system

Intervention Type 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.

Lung flute (OPEP)

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

Group Type ACTIVE_COMPARATOR

Lung flute (OPEP)

Intervention Type 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

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type DEVICE

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Mohamed El-Moatasem Mohamed

lecturer of physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Alaa El-Moatasem, lecturer

Role: CONTACT

01006625054

Omnia Ahmed, Lecturer

Role: CONTACT

01227805225

Facility Contacts

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Alaa El-Moatasem, lecturer

Role: primary

01006625054

Other Identifiers

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P.T.REC/012/003822

Identifier Type: -

Identifier Source: org_study_id

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