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Effects of Positive Expiratory Pressure Breathing Versus Incentive Spirometry on Dyspnea and Sputum Profile in Bronchiolectasis Patients
Sponsor study identifier
interventional
24
1 country
1
Study Start
June 1, 2022
Actual (reported)Primary Completion
December 31, 2022
Actual (reported)Study Completion
January 30, 2023
Actual (reported)Bronchiolectasis is the manifestation of chronic bronchitis characterized by saccular dilatation of the terminal bronchioles \& bronchiectasis refers to abnormal dilatation of the bronchi. In bronchiolectasis more proximal bronchi may or may not show radiological changes. Airway dilatation can lead to failure of mucus clearance and increased risk of infection. Pathophysiological mechanism of bronchiectasis/bronchiolectasis include persistent bacterial infections, deregulated immune responses, impaired mucociliary clearance and airway obstruction. Treatment is directed at reducing the frequency of exacerbations, improving quality of life. Although no therapy is licensed for bronchiectasis by regulatory agencies, evidence supports the effectiveness of airway clearance techniques, antibiotics and mucolytic agents. Enhancing effective expectoration of stagnated bronchopulmonary secretions, usually with physiotherapy support, is key to management. There are different methods for delivering chest physiotherapy, such as the active cycle of breathing technique, postural drainage, (PEP) and oscillating PEP devices. The objective of the study is to compare the effects of PEP \& Incentive spirometry techniques on bronchiolectasis patients. The study will be a randomized clinical trial. Total 24 subjects will be assigned randomly into two groups by using convenient sampling technique. Baseline treatment will be same (chest physiotherapy) in both groups. Group A will use PEP and Group B will use incentive spirometry technique for total 60 repetitions (15 repetitions 2 sets, two times per a day) 5 sessions per week and total 4 weeks. Dyspnea severity index and cough \& sputum assessment questionnaire (CASA-Q) would be used as an outcome measurement tools. Measurements will be taken at Baseline, and at the end of the 4 weeks treatment session. After assessing the normality, data will be analyzed by using parametric and non-parametric tests.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2023
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2022
Actual (reported)December 31, 2022
Actual (reported)January 30, 2023
Actual (reported)January 31, 2023
Actual (reported)February 9, 2023
Actual (reported)Dyspnea Severity Index
The Dyspnea severity index is a patient-centered questionnaire that can be used for assessment of initial severity of dyspnea symptoms related to the upper airway and can also be used as a follow-up assessment tool to evaluate treatment outcomes and drive evidence-based medical decisions.
4 Weeks
Cough and Sputum Assessment Questionnaire (CASA-Q)
The CASA-Q is a self-administered questionnaire that assesses cough and sputum based on their frequency, severity, and impact on daily activities in the previous 7 days. The CASA-Q contains four domains: cough symptoms, cough impact, sputum symptoms, and sputum impact.
4 Weeks
Group A
Group B
Group A containing 12 participants, will perform Positive expiratory pressure (PEP) technique for total 60 repetitions (15 repetitions 2 sets, twice) per a day (5 sessions/week and total 4 weeks).
Group B containing 12 participants, will perform Incentive spirometry technique for total 60 repetitions (15 repetitions 2 sets, twice) per a day (5 sessions/week and total 4 weeks).
Mayo Hospital Lahore
Lahore, Punjab Province, 54000, Pakistan
Anderson WH, Coakley RD, Button B, Henderson AG, Zeman KL, Alexis NE, Peden DB, Lazarowski ER, Davis CW, Bailey S, Fuller F, Almond M, Qaqish B, Bordonali E, Rubinstein M, Bennett WD, Kesimer M, Boucher RC. The Relationship of Mucus Concentration (Hydration) to Mucus Osmotic Pressure and Transport in Chronic Bronchitis. Am J Respir Crit Care Med. 2015 Jul 15;192(2):182-90. doi: 10.1164/rccm.201412-2230OC.
King PT. The pathophysiology of bronchiectasis. Int J Chron Obstruct Pulmon Dis. 2009;4:411-9. doi: 10.2147/copd.s6133. Epub 2009 Nov 29.
Hafiza Muriam Ghani, MSCPPT
Riphah International University
24 participants (actual enrollment reported by the registry).
First Submitted
January 31, 2023
First Posted
February 9, 2023
Study Start
June 1, 2022
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
WISOFF CP. Bronchiolectasis in chronic bronchitis. Radiology. 1958 Jun;70(6):848-50. doi: 10.1148/70.6.848. No abstract available.
Redondo M, Keyt H, Dhar R, Chalmers JD. Global impact of bronchiectasis and cystic fibrosis. Breathe (Sheff). 2016 Sep;12(3):222-235. doi: 10.1183/20734735.007516.
King PT, Holdsworth SR, Freezer NJ, Villanueva E, Holmes PW. Characterisation of the onset and presenting clinical features of adult bronchiectasis. Respir Med. 2006 Dec;100(12):2183-9. doi: 10.1016/j.rmed.2006.03.012. Epub 2006 May 2.
Dodd JD, Lavelle LP, Fabre A, Brady D. Imaging in cystic fibrosis and non-cystic fibrosis bronchiectasis. Semin Respir Crit Care Med. 2015 Apr;36(2):194-206. doi: 10.1055/s-0035-1546749. Epub 2015 Mar 31.
Chalmers JD, Chang AB, Chotirmall SH, Dhar R, McShane PJ. Bronchiectasis. Nat Rev Dis Primers. 2018 Nov 15;4(1):45. doi: 10.1038/s41572-018-0042-3.
Lee AL, Williamson HC, Lorensini S, Spencer LM. The effects of oscillating positive expiratory pressure therapy in adults with stable non-cystic fibrosis bronchiectasis: A systematic review. Chron Respir Dis. 2015 Feb;12(1):36-46. doi: 10.1177/1479972314562407. Epub 2014 Dec 17.
Gartner-Schmidt JL, Shembel AC, Zullo TG, Rosen CA. Development and validation of the Dyspnea Index (DI): a severity index for upper airway-related dyspnea. J Voice. 2014 Nov;28(6):775-82. doi: 10.1016/j.jvoice.2013.12.017. Epub 2014 Oct 12.
Reychler G, Uribe Rodriguez V, Hickmann CE, Tombal B, Laterre PF, Feyaerts A, Roeseler J. Incentive spirometry and positive expiratory pressure improve ventilation and recruitment in postoperative recovery: A randomized crossover study. Physiother Theory Pract. 2019 Mar;35(3):199-205. doi: 10.1080/09593985.2018.1443185. Epub 2018 Feb 27.
Primary Completion
December 31, 2022
Actual (reported)Study Completion
January 30, 2023
Actual (reported)Last Updated
February 9, 2023
Record last verified: 2023-01
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