Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High frequency extra thoracic oscillations vest
Intrathoracic oscillatory quake
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
- Faculty of physical therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vest arm
Quake arm
Arm Description
high frequency chest wall oscillation vest performed 4 times per week for 6 successive weeks for 30 patients
Vibratory positive expiratory pressure quake performed 4 times per week for 6 successive weeks for 30 patients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03885128
Brief Title
Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease
Official Title
Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vest arm
Arm Type
Experimental
Arm Description
high frequency chest wall oscillation vest performed 4 times per week for 6 successive weeks for 30 patients
Arm Title
Quake arm
Arm Type
Experimental
Arm Description
Vibratory positive expiratory pressure quake performed 4 times per week for 6 successive weeks for 30 patients
Intervention Type
Device
Intervention Name(s)
High frequency extra thoracic oscillations vest
Intervention Description
Oscillations applied extra thoracic through vest device aiming for airway clearance
Intervention Type
Device
Intervention Name(s)
Intrathoracic oscillatory quake
Intervention Description
Oscillation introduced intrathoracic through quake device through placing quake in mouth and ordering patient to breathing to move secretions
Primary Outcome Measure Information:
Title
Pulmonary function test (spirometry)
Description
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 Outcome Measure Information:
Title
impulse oscillometry
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagwa M Badr, Professor
Organizational Affiliation
Professor physical therapy at Cairo university
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of physical therapy
City
Dokki
State/Province
Giza
ZIP/Postal Code
12613
Country
Egypt
12. IPD Sharing Statement
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Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease
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