- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07402850
Oscillating Positive Expiratory Pressure Therapy Versus Autogenic Drainage in Patients With COPD (OPEP-AD-COPD)
Oscillating Positive Expiratory Pressure Therapy Versus Autogenic Drainage in Patients With Chronic Obstructive Pulmonary Disease: Effects on Pulmonary Function, Sputum Clearance, Dyspnea, and Quality of Life
Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung condition that causes breathing difficulty, cough, and sputum production. Airway clearance techniques are commonly used to help reduce symptoms and improve breathing in patients with COPD.
This study compared two airway clearance methods-oscillating positive expiratory pressure (OPEP) therapy and autogenic drainage-to determine which method is more effective in improving lung function, sputum clearance, shortness of breath, and quality of life in patients with COPD.
Participants were divided into two groups and received either OPEP therapy or autogenic drainage for four weeks. Outcomes were measured at the beginning of the study and again after completion of the intervention. The findings of this study aim to support evidence-based physiotherapy management for patients with COPD.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study was a comparative interventional clinical trial conducted to evaluate the effects of oscillating positive expiratory pressure therapy versus autogenic drainage in patients diagnosed with Chronic Obstructive Pulmonary Disease. Ethical approval was obtained from the institutional ethics review committee prior to study initiation, and written informed consent was obtained from all participants.
Eligible participants with stable COPD were enrolled and allocated into two intervention groups. Baseline assessments were performed prior to the initiation of treatment. Participants in the first group received oscillating positive expiratory pressure therapy as part of their airway clearance regimen, while participants in the second group were treated using autogenic drainage techniques. Both interventions were administered over a four-week period.
Outcome measures were assessed at two time points: baseline (pre-intervention) and after completion of the four-week intervention period. Pulmonary function was evaluated using spirometry. Sputum clearance was assessed using the Breathlessness Cough Sputum Scale (BCSS). Dyspnea was measured using the Modified Borg Dyspnea Scale, and quality of life was assessed using the COPD Assessment Test (CAT).
The results of this study aim to compare the effectiveness of the two airway clearance techniques and provide evidence to guide clinical decision-making in the physiotherapy management of patients with COPD.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 35 and 50 years
- Both genders
- Participants must have a confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) based on the GOLD 2023 guidelines
- Clinically stable
- History of Sputum Culture
Exclusion Criteria:
- Acute exacerbation of COPD
- Severe cardiovascular, neurological, or musculoskeletal disorders
- Recent thoracic or abdominal surgery
- Presence of other significant respiratory diseases
- Unwillingness to participate or inability to comply with the study protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Oscillating Positive Expiratory Pressure Therapy Group
Participants in this group received oscillating positive expiratory pressure therapy as an airway clearance technique for four weeks.
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Oscillating positive expiratory pressure therapy was administered using a handheld device to facilitate airway clearance by providing expiratory resistance and oscillations during exhalation.
The intervention was applied for four weeks.
|
|
Active Comparator: Autogenic Drainage Group
Participants in this group received autogenic drainage as an airway clearance technique for four weeks.
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Autogenic drainage is a breathing technique involving controlled breathing at different lung volumes to mobilize and clear bronchial secretions.
Participants performed autogenic drainage sessions for four weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second (FEV₁ % Predicted)
Time Frame: Baseline and at 4 weeks
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Pulmonary function was assessed using spirometry by measuring forced expiratory volume in one second (FEV₁), expressed as percentage of the predicted value, in patients with Chronic Obstructive Pulmonary Disease.
|
Baseline and at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sputum Clearance as Measured by the Breathlessness, Cough, and Sputum Scale (BCSS)
Time Frame: Baseline and at 4 weeks
|
Sputum clearance was assessed using the Breathlessness, Cough, and Sputum Scale (BCSS).
The BCSS is a patient-reported outcome measure consisting of three items (breathlessness, cough, and sputum), each scored from 0 to 4, resulting in a total score range of 0 to 12. Higher scores indicate worse symptoms.
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Baseline and at 4 weeks
|
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Change in Dyspnea Severity as Measured by the Modified Borg Dyspnea Scale
Time Frame: Baseline and at 4 weeks
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Dyspnea severity was assessed using the Modified Borg Dyspnea Scale, a numerical rating scale ranging from 0 to 10, where 0 represents no breathlessness and 10 represents maximal breathlessness.
Higher scores indicate greater perceived dyspnea.
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Baseline and at 4 weeks
|
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Change in Health-Related Quality of Life as Measured by the COPD Assessment Test (CAT)
Time Frame: Baseline and at 4 weeks
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Health-related quality of life was assessed using the COPD Assessment Test (CAT), an 8-item questionnaire with total scores ranging from 0 to 40.
Higher scores indicate worse health status and greater impact of COPD on daily life.
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Baseline and at 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adnan Hashim, DPT, Department of Physical Therapy, The University of Lahore
Publications and helpful links
General Publications
- Bridges, C., Graham-Wollard, L., Morris, H., Annandale, J., & Lewis, K. (2023). S56 A feasibility randomised control trial (RCT) of OPEP verses active cycle of breathing technique (ACBT) in people with chronic obstructive pulmonary disease (COPD). In: BMJ Publishing Group Ltd.
- Boers, E., Barrett, M., Su, J. G., Benjafield, A. V., Sinha, S., Kaye, L., Zar, H. J., Vuong, V., Tellez, D., Gondalia, R., Rice, M. B., Nunez, C. M., Wedzicha, J. A., & Malhotra, A. (2023). Global Burden of Chronic Obstructive Pulmonary Disease Through 2050. JAMA Netw Open, 6(12), e2346598. https://doi.org/10.1001/jamanetworkopen.2023.46598
- Bishop, K. L., & Malone, D. J. (2024). Pulmonary Diseases and Disorders. In Acute Care Physical Therapy (pp. 245-310). Routledge.
- Belli, S., Prince, I., Savio, G., Paracchini, E., Cattaneo, D., Bianchi, M., Masocco, F., Bellanti, M. T., & Balbi, B. (2021). Airway clearance techniques: the right choice for the right patient. Frontiers in medicine, 8, 544826.
- Awokola, B., Amusa, G., Jewell, C., Okello, G., Stobrink, M., Finney, L., Mohammed, N., Erhart, A., & Mortimer, K. (2022). Chronic obstructive pulmonary disease in sub-Saharan Africa. The International Journal of Tuberculosis and Lung Disease, 26(3), 232-242.
- Alruwaili, A. T. S., Alsirhani, A. F., khlaif Alrwili, A., Aldaghmi, M. T. A., Alharbi, S. E. M., & Aldhafeeri, R. Z. (2024). NURSING, PHYSICAL THERAPY, AND RESPIRATORY CARE IN ENHANCING PHYSICAL AND PSYCHOLOGICAL REHABILITATION FOR PATIENTS WITH RESPIRATORY DISEASES. Gland Surgery, 9(2).
- Alghamdi, S. M., Alsulayyim, A. S., Alasmari, A. M., Philip, K. E., Buttery, S. C., Banya, W. A., Polkey, M. I., Birring, S. S., & Hopkinson, N. S. (2023). Oscillatory positive expiratory pressure therapy in COPD (O-COPD): a randomised controlled trial. Thorax, 78(2), 136-143.
- Adeloye, D., Song, P., Zhu, Y., Campbell, H., Sheikh, A., & Rudan, I. (2022). Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. The Lancet Respiratory Medicine, 10(5), 447-458.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRI/IREB/26/01/0079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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