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

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Bronchiectasis
• Interventions: Other: Comprehensive Respiratory Physiotherapy

• Registration Number: NCT04170114
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Study Start: 2020-01-01
• Status Verified: 2020-11
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01
• Last Update Submitted: 2020-11-01
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bronchiectasis	Comprehensive Respiratory Physiotherapy	Children with bronchiectasis
Cystic Fibrosis	Comprehensive Respiratory Physiotherapy	Children with cystic fibrosis

Primary Outcome Measures

Name	Time	Method
Peak Expiratory Flow (PEF)	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	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	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)
M. Quadriceps strength	8 Weeks	sometric M. Quadriceps strength (kg) will be measured using electronic hand held dynamometer in sitting position.
Forced Vital Capacity (FVC)	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	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)	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)

Trial Locations

Locations (1)

Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation; 🇹🇷 Istanbul, Turkey