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NCT Number: NCT04170114

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

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.

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Key information

Conditions

Cystic Fibrosis Bronchial Diseases Bronchiectasis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Istanbul, 34060, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Respiratory Physiotherapy

Other

All patients will receive comprehensive respiratory physiotherapy training by the physiotherapist. All patients will undergo comprehensive respiratory physiotherapy techniques twice daily for 8 weeks.

Comprehensive respiratory physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control.

Primary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: 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)

  2. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 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)

  3. Peak Expiratory Flow (PEF)

    Time frame: 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)

  4. Respiratory Muscle Strength - MIP

    Time frame: 8 Weeks

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

  5. Respiratory Muscle Strength - MEP

    Time frame: 8 Weeks

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

  6. Six-minute walk test distance

    Time frame: 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)

  7. M. Quadriceps strength

    Time frame: 8 Weeks

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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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