Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: High frequency extra thoracic oscillations vest; Device: Intrathoracic oscillatory quake

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Dokki, Giza, Egypt, 12613
      • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vest arm; high frequency chest wall oscillation vest performed 4 times per week for 6 successive weeks for 30 patients	Device: High frequency extra thoracic oscillations vest; Oscillations applied extra thoracic through vest device aiming for airway clearance
Experimental: Quake arm; Vibratory positive expiratory pressure quake performed 4 times per week for 6 successive weeks for 30 patients	Device: Intrathoracic oscillatory quake; Oscillation introduced intrathoracic through quake device through placing quake in mouth and ordering patient to breathing to move secretions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function test (spirometry)	it measure ventilatory functions.; Then the patients sat comfortably and upright while putting the nose clip and relax.; The patient was asked to inhale as deeply as possible, hold the breath, and then inserted the mouthpiece carefully into the mouth.; The patient held the mouthpiece tightly between the lips, and kept tongue down.; The patient was asked to exhale for as long as possible and blow for at least 6 seconds.	Before and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impulse oscillometry	The patient was in sitting position, Legs kept uncrossed The patient firmly supported his cheeks during measurement. The mouthpiece was at a comfortable height so that the neck is slightly extended and ensure that there is a tight seal between the mouthpiece and lips to prevent air leak. The patient was instructed to perform normal tidal breathing in a relaxed state during the procedure. The recording was performed for at least 30-45 s. During this period, around 120-150 sound impulses were pushed into the lungs from which the mean reactance and resistance values were determined at frequencies from 5 to 20 Hz.	before and 6 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Nagwa M Badr, Professor, Professor physical therapy at Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: P.T.REC/012/001741

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No