Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis

Study Overview
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Brief Summary
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Cystic fibrosis (CF) is an autosomal recessive genetic disease characterized by recurrent airway infections, affecting many systems including lung, pancreas and sweat glands. Cough is an important defense mechanism for clearing the secretions that increase in respiratory diseases. There have been studies investigating the effect of expiratory muscle training on disease groups such as chronic obstructive pulmonary disease, multiple sclerosis, parkinson's disease, and the elderly and healthy individuals. Studies that evaluating effects of expiratory muscle training in cystic fibrosis are limited in the literature. The aim of this study was to evaluate the effect of cough strength in children and adolescents with CF and the effect of expiratory muscle training program on cough strength, exercise capacity, respiratory muscle strength and quality of life.

Official Title
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Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: expiratory muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with cystic fibrosis 8-18 years Clinically stable during last six weeks Exclusion Criteria: hemoptysis low saturation (SpO2<90%) acute lower respiratory tract infection cardiac problems (heart failure, arrhythmia, cardiomyopathy, etc.) cognitive problems pneumothorax

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Patients in experimental group will perform expiratory muscle training as home programme for at least five days a week, twice a day for 15 minutes at each session during six weeks by Threshold Positive Expiratory Pressure device. The intensity of training will been setted 30% of the maximal expiratory pressure level. | Other: expiratory muscle training<br>* The intensity of training will been determined after assessment of maximal expiratory pressure (MEP). The first training session will perform under the supervision of a physiotherapist, patients will perform training at home. MEP measurement will reevaluate every two weeks and the intensity of training will set according to MEP levels.<br>|
| Sham Comparator: Sham Group<br>In sham group, patients will perform expiratory muscle training at home for at least five days a week, twice a day for 15 minutes at each session during six weeks by Threshold Positive Expiratory Pressure device that the intensity of training will been setted 5 cm H₂O. | Other: expiratory muscle training<br>* The intensity of training will been determined after assessment of maximal expiratory pressure (MEP). The first training session will perform under the supervision of a physiotherapist, patients will perform training at home. MEP measurement will reevaluate every two weeks and the intensity of training will set according to MEP levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough capacity | peak expiratory flow meter | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle strength | maximal expiratory pressure, maximal inspiratory pressure | every two weeks | 
| Exercise capacity | six minute walking test | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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expiratory muscle training, cough, respiratory muscle strength, exercise capacity