Intra Versus Extra-thoracic Oscillations in Chronic Obstructive Pulmonary Disease

NCT03885128 | Completed

• 1 other identifier: P.T.REC/012/001741
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

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.

  Before and 6 weeks

Secondary Outcomes (1)

• impulse oscillometry

  before and 6 weeks

Study Arms (2)

Vest arm

EXPERIMENTAL

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

Quake arm

EXPERIMENTAL

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

Device: Intrathoracic oscillatory quake

Interventions

High frequency extra thoracic oscillations vest DEVICE

Oscillations applied extra thoracic through vest device aiming for airway clearance

Vest arm

Intrathoracic oscillatory quake DEVICE

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

Quake arm

Eligibility Criteria

• Age: 45 Years - 72 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Dokki, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Nagwa M Badr, Professor

  Professor physical therapy at Cairo university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 21, 2019
• Study Start: November 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 30, 2019
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

EG (1)