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Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Device: Intrathoracic oscillatory quake
Device: High frequency extra thoracic oscillations vest

Study type

Interventional

Funder types

Other

Identifiers

NCT03885128
P.T.REC/012/001741

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Male

Ages

45 to 72 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Vest arm
Experimental group
Description:
high frequency chest wall oscillation vest performed 4 times per week for 6 successive weeks for 30 patients
Treatment:
Device: High frequency extra thoracic oscillations vest
Quake arm
Experimental group
Description:
Vibratory positive expiratory pressure quake performed 4 times per week for 6 successive weeks for 30 patients
Treatment:
Device: Intrathoracic oscillatory quake

Trial contacts and locations

1

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Central trial contact

Alaa M Elmotasm, ass Lecturer; Nagwa M Badr, Professor

Data sourced from clinicaltrials.gov

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