NCT06801106

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,

ACAPELLA VERSUS LUNG FLUTE in TREATMENT of CHRONIC OBSTRUCTIVE PULMONARY DISEASE

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Ministry of Health and Population, Egypt · Other Government
• Sex: Male
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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
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

Timeline

• Start date: 2021-01-31
• Primary completion: 2024-01-20
• Completion: 2024-01-20
• First posted: 2025-01-30
• Last updated: 2025-01-30

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study