PEP Breathing Versus Incentive Spirometry on Dyspnea and Sputum Profile in Bronchiolectasis Patients

NCT ID: NCT05719597

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-01-30

Brief Summary

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.

Conditions

Bronchiolectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PEP (Positive Expiratory Pressure)

Group A

Group Type: EXPERIMENTAL

PEP (Positive Expiratory Pressure)

Intervention Type: OTHER

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).

IS (Incentive Spirometry)

Group B

Group Type: EXPERIMENTAL

IS (Incentive spirometry)

Intervention Type: OTHER

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).

Interventions

PEP (Positive Expiratory Pressure)

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).

Intervention Type: OTHER

IS (Incentive spirometry)

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age group of 22 to 85 years
• Both GenderCOVID-19 negative
• Indoor patients
• Ability to use PEP devices
• Diagnosed Bronchiolectasis Patients (through CT scan, X-Ray)

Exclusion Criteria

• Rib fracture
• Neurological problems
• Lungs carcinomas
• Any other serious comorbidity

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hafiza Muriam Ghani, MSCPPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Mayo Hospital Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 25909230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20037680 (View on PubMed)

WISOFF CP. Bronchiolectasis in chronic bronchitis. Radiology. 1958 Jun;70(6):848-50. doi: 10.1148/70.6.848. No abstract available.

Reference Type: BACKGROUND

PMID: 13554852 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28210295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16650970 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25826587 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30442957 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25518845 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25311596 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29485340 (View on PubMed)

Other Identifiers

REC/RCR&AHS/22/0352

Identifier Type: -

Identifier Source: org_study_id