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

Primary Purpose

Bronchiolectasis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
PEP (Positive Expiratory Pressure)
IS (Incentive spirometry)
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolectasis focused on measuring Bronchiolectasis, Dyspnea Severity Index, Incentive Spirometry, Positive Expiratory Pressure (PEP), Saccular Dilation

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Hospital Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PEP (Positive Expiratory Pressure)

IS (Incentive Spirometry)

Arm Description

Group A

Group B

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2023
Last Updated
January 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05719597
Brief Title
PEP Breathing Versus Incentive Spirometry on Dyspnea and Sputum Profile in Bronchiolectasis Patients
Official Title
Effects of Positive Expiratory Pressure Breathing Versus Incentive Spirometry on Dyspnea and Sputum Profile in Bronchiolectasis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolectasis
Keywords
Bronchiolectasis, Dyspnea Severity Index, Incentive Spirometry, Positive Expiratory Pressure (PEP), Saccular Dilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEP (Positive Expiratory Pressure)
Arm Type
Experimental
Arm Description
Group A
Arm Title
IS (Incentive Spirometry)
Arm Type
Experimental
Arm Description
Group B
Intervention Type
Other
Intervention Name(s)
PEP (Positive Expiratory Pressure)
Intervention Description
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
Intervention Name(s)
IS (Incentive spirometry)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Dyspnea Severity Index
Description
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.
Time Frame
4 Weeks
Title
Cough and Sputum Assessment Questionnaire (CASA-Q)
Description
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.
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Muriam Ghani, MSCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25909230
Citation
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.
Results Reference
background
PubMed Identifier
20037680
Citation
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.
Results Reference
background
PubMed Identifier
13554852
Citation
WISOFF CP. Bronchiolectasis in chronic bronchitis. Radiology. 1958 Jun;70(6):848-50. doi: 10.1148/70.6.848. No abstract available.
Results Reference
background
PubMed Identifier
28210295
Citation
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.
Results Reference
background
PubMed Identifier
16650970
Citation
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.
Results Reference
background
PubMed Identifier
25826587
Citation
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.
Results Reference
background
PubMed Identifier
30442957
Citation
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.
Results Reference
background
PubMed Identifier
25518845
Citation
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.
Results Reference
background
PubMed Identifier
25311596
Citation
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.
Results Reference
background
PubMed Identifier
29485340
Citation
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.
Results Reference
background

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

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