Clinical trial NCT05719597: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolectasis
Keywords: Bronchiolectasis
Dyspnea Severity Index
Incentive Spirometry
Positive Expiratory Pressure (PEP)
Saccular Dilation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 24
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Dyspnea Severity Index
timeFrame: 4 Weeks
measure: Cough and Sputum Assessment Questionnaire (CASA-Q)
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mayo Hospital Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hafiza Muriam Ghani, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
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