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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Airway Disease
• Intervention / Treatment: Device: Acapella; Device: Lung flute

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Spirometer	Spirometer will be used to assess pulmonary functions ( FEV1 , FEV 6 , FVC , FEV1/ FVC)	pulmonary functions will be measured at baseline, and it will be measured again after eight weeks.
6 minute walk test	The 6MWT measures exercise tolerance in people with various health conditions. Not only is the test a way to measure the general health of an individual, but a doctor can also use it to monitor the effectiveness of the current treatment plan and see whether it is improving a person's condition	6 min walk test will be measured at baseline, and it will be measured again after eight weeks
The VQ11 Quality of life questionnaire	was used to determine the functional, psychological, relational and total scores.	Vq 11 will be measured at baseline, and it will be measured again after eight weeks

Collaborators and Investigators

• Sponsor: Ministry of Health and Population, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2021
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: P.T.REC/012/002208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes