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

Not Applicable

Completed

• Conditions: Bronchiolectasis
• Interventions: Other: IS (Incentive spirometry); Other: PEP (Positive Expiratory Pressure)

• Registration Number: NCT05719597
• Lead Sponsor: Riphah International University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2022-12-31
• Status Verified: 2023-01
• Study Completion: 2023-01-30
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Last Update Submitted: 2023-01-31
• Study First Posted: 2023-02-09
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IS (Incentive Spirometry)	IS (Incentive spirometry)	Group B
PEP (Positive Expiratory Pressure)	PEP (Positive Expiratory Pressure)	Group A

Primary Outcome Measures

Name	Time	Method
Cough and Sputum Assessment Questionnaire (CASA-Q)	4 Weeks	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.
Dyspnea Severity Index	4 Weeks	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.

Trial Locations

Locations (1)

Mayo Hospital Lahore; 🇵🇰 Lahore, Punjab, Pakistan