Skip to main content
OpenTrials
Completed

NCT Number: 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,

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt, 11432

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acapella

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

Device

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

Primary outcomes

  1. • Spirometer

    Time frame: pulmonary functions will be measured at baseline, and it will be measured again after eight weeks.

    Spirometer will be used to assess pulmonary functions ( FEV1 , FEV 6 , FVC , FEV1/ FVC)

  2. 6 minute walk test

    Time frame: 6 min walk test will be measured at baseline, and it will be measured again after eight weeks

    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

  3. The VQ11 Quality of life questionnaire

    Time frame: Vq 11 will be measured at baseline, and it will be measured again after eight weeks

    was used to determine the functional, psychological, relational and total scores.

Sponsors and collaborators

Lead sponsor

Ministry of Health and Population, Egypt

Other Gov

Registry information

Official study title

ACAPELLA VERSUS LUNG FLUTE in TREATMENT of CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.