CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
PEP (Positive Expiratory Pressure) +1 moreother
Likely dose
Not stated in record
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Search/NCT05719597
NCT05719597N/ACompleted

Effects of Positive Expiratory Pressure Breathing Versus Incentive Spirometry on Dyspnea and Sputum Profile in Bronchiolectasis Patients

Riphah International University·interventional·Posted Feb 9, 2023·Updated Feb 9, 2023

In Brief

A clinical study evaluating PEP (Positive Expiratory Pressure) and IS (Incentive spirometry) for Bronchiolectasis. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPakistan
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedFeb 9, 2023
Enrollment StartJun 1, 2022
Primary CompletionDec 31, 2022
Study CompletionJan 30, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.4 years ago

Interventions

PEP (Positive Expiratory Pressure)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)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).