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Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT03885128
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Alaa Mohamed El-Moatasem Mohamed, Cairo University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: High frequency extra thoracic oscillations vest Device: Intrathoracic oscillatory quake Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.



Eligibility Criteria
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Ages Eligible for Study:   45 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885128


Contacts
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Contact: Alaa M Elmotasm, ass Lecturer 0201006625054 Alaamotasm@rocketmail.com
Contact: Nagwa M Badr, Professor 021223683849 nagwambadr@yahoo.com

Locations
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Egypt
Faculty of physical therapy Recruiting
Dokki, Giza, Egypt, 12613
Contact: Nagwa M Badr, Professor       nagwambadr@yahoo.com   
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Nagwa M Badr, Professor Professor physical therapy at Cairo university
More Information
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Responsible Party: Alaa Mohamed El-Moatasem Mohamed, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03885128    
Other Study ID Numbers: P.T.REC/012/001741
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases