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Completed

NCT Number: NCT03873688

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cough Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Expiratory Muscle Training

Other

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.

Primary outcomes

  1. Cough capacity

    Time frame: 6 weeks

    peak expiratory flow meter

Secondary outcomes

  1. Respiratory muscle strength

    Time frame: every two weeks

    maximal expiratory pressure, maximal inspiratory pressure

  2. Exercise capacity

    Time frame: 6 weeks

    six minute walking test

Sponsors and collaborators

Lead sponsor

Cigdem Emirza

Other

Collaborators

  • Istanbul University

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2019
Registry last updated
Nov 13, 2019

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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