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CompletedNCT03885128Updated Aug 30, 2023

Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease

An interventional study of High frequency extra thoracic oscillations vest and Intrathoracic oscillatory quake in Chronic Obstructive Pulmonary Disease, sponsored by Cairo University. Completed at 1 site in Egypt. Open to male participants aged 45 Years to 72 Years. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2017, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
45 Years to 72 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
03

In context

Pulmonary Disease, Chronic Obstructive

4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 72 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • 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

  • Experimental
    Quake arm

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

    Device: Intrathoracic oscillatory quake

Interventions

  • DeviceHigh frequency extra thoracic oscillations vest

    Oscillations applied extra thoracic through vest device aiming for airway clearance

  • DeviceIntrathoracic oscillatory quake

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before and 6 weeks

Secondary outcomes

  1. 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.

    Time frame: before and 6 weeks

07

Study locations

1 site
  • Faculty of physical therapy
    Dokki, Giza Governorate 12613, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03885128
Lead sponsor
Cairo University
Responsible party
Alaa Mohamed El-Moatasem Mohamed (Principal investigator, Cairo University) — Principal investigator
First posted
Mar 21, 2019
Start date
Nov 1, 2017
Primary completion
May 1, 2019
Completion
May 30, 2019
Last update
Aug 30, 2023

Study contacts

Nagwa M Badr, Professor
study chair · Professor physical therapy at Cairo university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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