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CompletedNCT03873688Updated Nov 13, 2019

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

An interventional study of expiratory muscle training in Cystic Fibrosis, sponsored by Cigdem Emirza. Completed at 1 site in Turkey. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by Cigdem Emirza · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study 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.

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Conditions studied

  • Cystic Fibrosis

Keywords

  • expiratory muscle training
  • cough
  • respiratory muscle strength
  • exercise capacity
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In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 28 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

This is the only study on the registry with Cigdem Emirza as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Diagnosed with cystic fibrosis
  • 8-18 years
  • Clinically stable during last six weeks

Exclusion criteria

Exclusion Criteria:

  • hemoptysis
  • low saturation (SpO2\<90%)
  • acute lower respiratory tract infection
  • cardiac problems (heart failure, arrhythmia, cardiomyopathy, etc.)
  • cognitive problems
  • pneumothorax
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Otherexpiratory 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.

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What researchers measure

Primary outcomes

  1. Cough capacity

    peak expiratory flow meter

    Time frame: 6 weeks

Secondary outcomes

  1. Respiratory muscle strength

    maximal expiratory pressure, maximal inspiratory pressure

    Time frame: every two weeks

  2. Exercise capacity

    six minute walking test

    Time frame: 6 weeks

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Study locations

1 site
  • Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty
    Istanbul, Turkey
08

References and documents

Publications

  • Emirza C, Aslan GK, Kilinc AA, Cokugras H. Effect of expiratory muscle training on peak cough flow in children and adolescents with cystic fibrosis: A randomized controlled trial. Pediatr Pulmonol. 2021 May;56(5):939-947. doi: 10.1002/ppul.25259. Epub 2021 Jan 26. PubMed 33421333 ↗
  • Stanford G, Ryan H, Solis-Moya A. Respiratory muscle training for cystic fibrosis. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD006112. doi: 10.1002/14651858.CD006112.pub5. PubMed 33331663 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03873688
Lead sponsor
Cigdem Emirza
Collaborators
Istanbul University
Responsible party
Cigdem Emirza (Physiotherapist, Istanbul University) — Sponsor-investigator
First posted
Mar 13, 2019
Start date
Jan 2, 2019
Primary completion
Oct 31, 2019
Completion
Oct 31, 2019
Last update
Nov 13, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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