Chronic Obstructive Airway DiseaseNCT06801106
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,
A study testing Acapella and Lung flute in people with Chronic Obstructive Airway Disease, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Chronic Obstructive Airway Disease
- What is being tested?
- Acapella and Lung flute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2021to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Acapella, Lung flute
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcapellaDevice
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 fluteDevice
is a new oscillatory positive expiratory pressure (OPEP) device that produces a low frequency acoustic wave with vigorous exhalation that increases mucociliary clearance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Lung flute |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Spirometer
Spirometer will be used to assess pulmonary functions ( FEV1 , FEV 6 , FVC , FEV1/ FVC)
Measured: 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
Measured: 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.
Measured: Vq 11 will be measured at baseline, and it will be measured again after eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start31 Jan 2021
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Airway DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Population, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Hussein El Dessouky, Ministry of Health and Population, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801106
- Sponsor's protocol ID
- P.T.REC/012/002208
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACAPELLA VERSUS LUNG FLUTE in TREATMENT of CHRONIC OBSTRUCTIVE PULMONARY DISEASE
- ClinicalTrials.gov ID
- NCT06801106
- Acronym / sponsor ID
- P.T.REC/012/002208
- Conditions
- Chronic Obstructive Airway Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ministry of Health and Population, EgyptOther government
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acapella | Experimental | Device: Acapellapatients 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. |
| Lung flute | Active comparator | Device: Lung flutepatients 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- • History of osteoporosis, significant gastro-esophageal reflux, hiatus hernia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acapellais 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 | Acapella |
| Lung fluteis a new oscillatory positive expiratory pressure (OPEP) device that produces a low frequency acoustic wave with vigorous exhalation that increases mucociliary clearance | Device | Lung flute |
Primary outcome
• 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)
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acapella and Lung flute in people with Chronic Obstructive Airway Disease, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Spirometer (time frame: pulmonary functions will be measured at baseline, and it will be measured again after eight weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.