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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis; Cystic Fibrosis
• Intervention / Treatment: Other: Comprehensive Respiratory Physiotherapy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34060
    • Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cystic Fibrosis; Children with cystic fibrosis	Other: Comprehensive Respiratory Physiotherapy; 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.
Experimental: Bronchiectasis; Children with bronchiectasis	Other: Comprehensive Respiratory Physiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Vital Capacity (FVC)	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)	8 Weeks
Forced Expiratory Volume in 1 second (FEV1)	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)	8 Weeks
Peak Expiratory Flow (PEF)	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)	8 Weeks
Respiratory Muscle Strength - MIP	Maximum Inspiratory Pressure (MIP) will be measured using MicroRPM portable manometer and the unit will be expressed in mmHg	8 Weeks
Respiratory Muscle Strength - MEP	Maximum Expiratory Pressure (MEP) will be measured using MicroRPM portable manometer and the unit will be expressed in mmHg	8 Weeks
Six-minute walk test distance	Distance walked in six minutes will be recorded in meters. Test will be conducted according to the guideline of American Thoracic Society (ATS)	8 Weeks
M. Quadriceps strength	sometric M. Quadriceps strength (kg) will be measured using electronic hand held dynamometer in sitting position.	8 Weeks

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Exercise Capacity; Cystic Fibrosis; Pulmonary Function; Muscle Strength; Bronchiectasis; Six Minute Walk Test; Respiratory Physiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Bronchial Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Bronchiectasis; Cystic Fibrosis
• Other Study ID Numbers: bvuhucgun02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No