Acapella Versus Lung Flute in Treatment of COPD Patients the Study Aims to Identify the Preference Between the Two Devices According to Treatment of COPD Patients Regarding Pulmonary Function Tests , Exercise Tolerence and Quality of Life Questionnaire,

NCT ID: NCT06801106

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2024-01-20

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a prevalent and progressive condition characterized by persistent airflow limitation and chronic respiratory symptoms. Among the many approaches to managing COPD, airway clearance techniques (ACTs) play a pivotal role in improving pulmonary function, reducing symptoms, and enhancing quality of life. So, this study aimed to investigate the comparative efficacy of two ACT devices-the Acapella® and the Lung Flute®- on improving pulmonary function, exercise capacity, and quality of life in COPD patients.

The Acapella® and the Lung Flute®. Both devices utilize distinct mechanisms to facilitate mucus clearance and improve lung function. The Acapella® combines positive expiratory pressure (PEP) with oscillatory vibration, aiding in the loosening and mobilization of mucus . On the other hand, the Lung Flute® generates low-frequency sound waves through patient exhalation, stimulating mucus movement from the peripheral to central airways . While both devices have demonstrated efficacy in previous studies, there is limited comparative research evaluating their impact in COPD patients.

Detailed Description

A controlled randomized study having 70 individuals with COPD was conducted. Before the treatment began, all participants signed a permission after being informed about the study's specifics and their rights as patients. The Ethics Committee Board of Cairo University's Faculty of Physical Therapy authorized this study (P.T.REC/012/002208). The research was done in accordance with the Helsinki 0 male COPD patients aged 40-60 years, recruited from Kasr Al Ainy Hospital, Cairo University. Participants were diagnosed with moderate to severe COPD and were randomly assigned into two groups: Group A received Acapella® therapy alongside standard chest physiotherapy, and Group B received Lung Flute® therapy with the same physiotherapy protocol. Both groups underwent interventions every other day for eight weeks. Outcomes were assessed using pulmonary function tests (PFTs), the six-minute walk test (6MWT), and the VQ11 quality-of-life questionnaire.

Conditions

Chronic Obstructive Airway Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acapella

patients received medical treatment only and conventional chest physical therapy (including diaphragmatic breathing, postural drainage, vibration and huffing and coughing techniques) in addition to respiratory training using acapella device for one time day after day for 8 consecutive weeks.

Group Type: EXPERIMENTAL

Acapella

Intervention Type: DEVICE

is an airway clearance device that combines the resistive features of a positive expiratory pressure device with oscillations, which diminishes the mucus adhesiveness and decrease the collapsibility of airways

Lung flute

patients received medical treatment only and conventional chest (including diaphragmatic breathing, postural drainage, vibration and huffing and coughing techniques) physical therapy in addition to respiratory training using Lung flute device one time day after day for 8 consecutive weeks.

Group Type: ACTIVE_COMPARATOR

Lung flute

Intervention Type: DEVICE

is a new oscillatory positive expiratory pressure (OPEP) device that produces a low frequency acoustic wave with vigorous exhalation that increases mucociliary clearance

Interventions

Acapella

is an airway clearance device that combines the resistive features of a positive expiratory pressure device with oscillations, which diminishes the mucus adhesiveness and decrease the collapsibility of airways

Intervention Type: DEVICE

Lung flute

is a new oscillatory positive expiratory pressure (OPEP) device that produces a low frequency acoustic wave with vigorous exhalation that increases mucociliary clearance

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Moderate and mild severe COPD patients were selected according GOLD guidelines.

• All patients were diagnosed as COPD with chronic bronchitis for at least two years.
• All Patients were using their prescribed medications including Broncho-dilators and mucolytics.
• Patients ceased smoking 2 months before undergoing the study.
• Patients were selected of BMI between 25-34.9.

Exclusion Criteria

• • 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.
• Patients undergoing exacerbations.
• Patients of hospital admission in last 6 month.
• Patients with cough, rhonchi, and expectoration in last 6 month.
• Patients who undergo exertional desaturation of oxygen below 90% after 6MWT.
• Patients who suffer from prolonged recovery time of HR for more than one minute after finishing 6MWT.
• Prolonged recovery time of heart rate <1 min.
• Patients who cannot walk.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health and Population, Egypt

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmed Hussein El Dessouky

B.Sc. in Physical Therapy (2009) Physical Therapist at Abu El Nomros Central Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, Egypt, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/002208

Identifier Type: -

Identifier Source: org_study_id