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

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ClinicalTrials.gov Identifier: NCT03873688
Recruitment Status : Enrolling by invitation
First Posted : March 13, 2019
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
Istanbul University
Information provided by (Responsible Party):
Cigdem Emirza, Istanbul University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: expiratory muscle training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group
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
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.

Sham Comparator: Sham Group
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
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 Outcome Measures :
  1. Cough capacity [ Time Frame: 6 weeks ]
    peak expiratory flow meter


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873688


Locations
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Turkey
Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul, Turkey
Sponsors and Collaborators
Cigdem Emirza
Istanbul University

Additional Information:
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Responsible Party: Cigdem Emirza, Physiotherapist, Istanbul University
ClinicalTrials.gov Identifier: NCT03873688     History of Changes
Other Study ID Numbers: TYL-2018-31769
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cigdem Emirza, Istanbul University:
expiratory muscle training
cough
respiratory muscle strength
exercise capacity

Additional relevant MeSH terms:
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Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases