Comparison of the Efficacy of Comprehensive Respiratory Physiotherapy in Children With Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis
Primary Purpose
Cystic Fibrosis, Bronchiectasis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Comprehensive Respiratory Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Bronchiectasis, Respiratory Physiotherapy, Pulmonary Function, Exercise Capacity, Six Minute Walk Test, Muscle Strength
Eligibility Criteria
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
Sites / Locations
- Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cystic Fibrosis
Bronchiectasis
Arm Description
Children with cystic fibrosis
Children with bronchiectasis
Outcomes
Primary Outcome Measures
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)
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)
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)
Respiratory Muscle Strength - MIP
Maximum Inspiratory Pressure (MIP) will be measured using MicroRPM portable manometer and the unit will be expressed in mmHg
Respiratory Muscle Strength - MEP
Maximum Expiratory Pressure (MEP) will be measured using MicroRPM portable manometer and the unit will be expressed in mmHg
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)
M. Quadriceps strength
sometric M. Quadriceps strength (kg) will be measured using electronic hand held dynamometer in sitting position.
Secondary Outcome Measures
Full Information
NCT ID
NCT04170114
First Posted
November 12, 2019
Last Updated
November 1, 2020
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04170114
Brief Title
Comparison of the Efficacy of Comprehensive Respiratory Physiotherapy in Children With Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis
Official Title
Comparison of the Efficacy of Comprehensive Respiratory Physiotherapy in Children With Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Bronchiectasis
Keywords
Cystic Fibrosis, Bronchiectasis, Respiratory Physiotherapy, Pulmonary Function, Exercise Capacity, Six Minute Walk Test, Muscle Strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cystic Fibrosis
Arm Type
Experimental
Arm Description
Children with cystic fibrosis
Arm Title
Bronchiectasis
Arm Type
Experimental
Arm Description
Children with bronchiectasis
Intervention Type
Other
Intervention Name(s)
Comprehensive Respiratory Physiotherapy
Intervention Description
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 Outcome Measure Information:
Title
Forced Vital Capacity (FVC)
Description
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)
Time Frame
8 Weeks
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
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)
Time Frame
8 Weeks
Title
Peak Expiratory Flow (PEF)
Description
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)
Time Frame
8 Weeks
Title
Respiratory Muscle Strength - MIP
Description
Maximum Inspiratory Pressure (MIP) will be measured using MicroRPM portable manometer and the unit will be expressed in mmHg
Time Frame
8 Weeks
Title
Respiratory Muscle Strength - MEP
Description
Maximum Expiratory Pressure (MEP) will be measured using MicroRPM portable manometer and the unit will be expressed in mmHg
Time Frame
8 Weeks
Title
Six-minute walk test distance
Description
Distance walked in six minutes will be recorded in meters. Test will be conducted according to the guideline of American Thoracic Society (ATS)
Time Frame
8 Weeks
Title
M. Quadriceps strength
Description
sometric M. Quadriceps strength (kg) will be measured using electronic hand held dynamometer in sitting position.
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation
City
Istanbul
ZIP/Postal Code
34060
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of the Efficacy of Comprehensive Respiratory Physiotherapy in Children With Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis
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