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临床试验/NCT04170114
NCT04170114已完成不适用

Comparison of the Efficacy of Comprehensive Respiratory Physiotherapy in Children With Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1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
60
试验地点
2
主要终点
M. Quadriceps strength

研究概览

简要总结

The effect of comprehensive respiratory physiotherapy applications on respiratory function, functional capacity and peripheral muscle strength in children with cystic fibrosis and non-cystic fibrosis will be compared.

详细描述

Bronchiectasis may be a congenital cause such as cystic fibrosis (CF) or non-cystic fibrosis such as primary ciliary dyskinesia, post-infectious conditions, aspiration and immunodeficiency; It is a disease characterized by irreversible dilatation of airways. Symptoms; purulent sputum production, chronic cough, hemoptysis, recurrent fever and pleurisy. Mucociliary clearance disorder secondary to inflammation and involvement of exocrine glands in CF plays a major role in the development of symptoms; In non-cystic fibrosis bronchiectasis (NCFB), the development of similar symptoms may occur regardless of these reasons. However, in the examinations of CF, proximal airways; In NCFB, distal airways have been affected more intensively. As part of pulmonary rehabilitation, comprehensive respiratory physiotherapy (CRP) has an important role in the treatment and management of bronchiectasis. Airway cleaning techniques, approaches to reducing respiratory work, and patient education form the basis of CRP and play an active role in the treatment and management of the disease. In the literature, there are studies in which the effects of CRP are given in both CF and NCFB patients and studies comparing evaluation results in both groups without treatment. However, no study was found to compare the efficacy of CRP in these two groups of diseases. Therefore, in this study, the investigators aimed to investigate the differences between the efficacy of CRP among the groups in children with CF and NCFB.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Being between 6-18 years old
  • Clinically diagnosed as cystic fibrosis or non-cystic fibrosis bronchiectasis

排除标准

  • Previous history of lung or liver transplantation
  • Have had an acute exacerbation in the last month and / or have a history of hospitalization
  • Having a diagnosis of orthopedic problems affecting mobility or a history of musculoskelatal surgery

结局指标

主要结局

M. Quadriceps strength

时间窗: 8 Weeks

sometric M. Quadriceps strength (kg) will be measured using electronic hand held dynamometer in sitting position.

Peak Expiratory Flow (PEF)

时间窗: 8 Weeks

PEF will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

Respiratory Muscle Strength - MEP

时间窗: 8 Weeks

Maximum Expiratory Pressure (MEP) will be measured using MicroRPM portable manometer and the unit will be expressed in mmHg

Six-minute walk test distance

时间窗: 8 Weeks

Distance walked in six minutes will be recorded in meters. Test will be conducted according to the guideline of American Thoracic Society (ATS)

Forced Vital Capacity (FVC)

时间窗: 8 Weeks

FVC will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

Respiratory Muscle Strength - MIP

时间窗: 8 Weeks

Maximum Inspiratory Pressure (MIP) will be measured using MicroRPM portable manometer and the unit will be expressed in mmHg

Forced Expiratory Volume in 1 second (FEV1)

时间窗: 8 Weeks

FEV1 will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

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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