Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease

NCT ID: NCT03885128

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2019-05-30

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is the fourth-leading cause of death. It is a progressive illness that requires life-long treatment.Promoting airway clearance (AC) using mucolytics together with airway clearance techniques (ACTs) form the basis for pulmonary therapy in COPD care.Therefore, new airway clearance modalities are required to decrease the detrimental effects of accumulated secretions in COPD.

One of the devices used in AC is the high frequency chest wall oscillation (The Vest). HFCWO involves the use of an inflatable vest/jacket that covers the chest and is attached to an air pulse-generating compressor which rapidly inflates and deflates the vest, producing oscillations to the chest wall of 5-25 Hz.

Another new airway clearance modality is oscillating positive expiratory pressure(Quake) which combines PEP therapy with high frequency oscillations.

Detailed Description

The present study aimed to evaluate the effectiveness of the extra thoracic oscillations via high frequency chest wall oscillation vest (HFCWO) versus the intra thoracic oscillations via oscillatory positive expiratory pressure (OPEP) Quake device in COPD Group A: consists of 30 patients will be treated by high frequency chest wall oscillation vest along with their prescribed medical treatment. This program will be performed 4 times per week for 6 successive weeks.

Group B: consists of 30 patients will be treated by vibratory PEP (The Quake) along with their prescribed medical treatment. This program will be performed 4 times per week for 6 successive weeks.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vest arm

high frequency chest wall oscillation vest performed 4 times per week for 6 successive weeks for 30 patients

Group Type: EXPERIMENTAL

High frequency extra thoracic oscillations vest

Intervention Type: DEVICE

Oscillations applied extra thoracic through vest device aiming for airway clearance

Quake arm

Vibratory positive expiratory pressure quake performed 4 times per week for 6 successive weeks for 30 patients

Group Type: EXPERIMENTAL

Intrathoracic oscillatory quake

Intervention Type: DEVICE

Oscillation introduced intrathoracic through quake device through placing quake in mouth and ordering patient to breathing to move secretions

Interventions

High frequency extra thoracic oscillations vest

Oscillations applied extra thoracic through vest device aiming for airway clearance

Intervention Type: DEVICE

Intrathoracic oscillatory quake

Oscillation introduced intrathoracic through quake device through placing quake in mouth and ordering patient to breathing to move secretions

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• • All patients were diagnosed by chest physician based on the modified criteria defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2017.

• All patients were diagnosed as COPD for at least two years.
• All Patients must use their prescribed medications.

Exclusion Criteria

• All patients that had one of the following were excluded from the study. History of osteoporosis, significant gastro-esophageal reflux, hiatus hernia. Recent acute cardiac event (6 weeks) or congestive cardiac failure. Any significant musculoskeletal disorders. Presence of active hemoptysis Presence of malignant disease

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mohamed El-Moatasem Mohamed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nagwa M Badr, Professor

Role: STUDY_CHAIR

Professor physical therapy at Cairo university

Locations

Faculty of physical therapy

Dokki, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/001741

Identifier Type: -

Identifier Source: org_study_id