Clinical trial 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,
Official title: ACAPELLA VERSUS LUNG FLUTE in TREATMENT of CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Airway Disease
Lead sponsor: Ministry of Health and Population, Egypt
Sponsor class: OTHER_GOV
First posted: 2025-01-30
Enrollment: 70
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: • Spirometer
timeFrame: pulmonary functions will be measured at baseline, and it will be measured again after eight weeks.
measure: 6 minute walk test
timeFrame: 6 min walk test will be measured at baseline, and it will be measured again after eight weeks
measure: The VQ11 Quality of life questionnaire
timeFrame: Vq 11 will be measured at baseline, and it will be measured again after eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: