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临床试验/NCT05719597
NCT05719597已完成不适用

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

Riphah International University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Cough and Sputum Assessment Questionnaire (CASA-Q)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
22 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Cough and Sputum Assessment Questionnaire (CASA-Q)

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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