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

November 12, 2019 updated by: Cigdem Emirza
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cigdem Emirza

Collaborators

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2019

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (ACTUAL)

March 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYL-2018-31769

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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