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Completed

NCT Number: NCT03885128

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–72 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy

Dokki, Giza Governorate, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High frequency extra thoracic oscillations vest

Device

Oscillations applied extra thoracic through vest device aiming for airway clearance

Intrathoracic oscillatory quake

Device

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

Primary outcomes

  1. Pulmonary function test (spirometry)

    Time frame: Before and 6 weeks

    • 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.

Secondary outcomes

  1. impulse oscillometry

    Time frame: before and 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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