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,

NCT06801106 | Completed FDA Device

• 1 other identifier: P.T.REC/012/002208
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Airway Disease

Outcome Measures

Primary Outcomes (3)

• • 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

Study Arms (2)

Acapella

EXPERIMENTAL

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

Lung flute

ACTIVE COMPARATOR

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

Interventions

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

Acapella

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

Lung flute

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: males only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Health and Population, Egypt: lead

Study Sites (1)

Cairo University

Cairo, Egypt, 11432, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.Sc. in Physical Therapy (2009) Physical Therapist at Abu El Nomros Central Hospital

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: January 31, 2021
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: January 30, 2025

Record last verified: 2021-01

Locations

EG (1)