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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
expiratory muscle training
Sponsored by
Cigdem Emirza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring expiratory muscle training, cough, respiratory muscle strength, exercise capacity

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental Group

Sham Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cough capacity
peak expiratory flow meter

Secondary Outcome Measures

Respiratory muscle strength
maximal expiratory pressure, maximal inspiratory pressure
Exercise capacity
six minute walking test

Full Information

First Posted
March 12, 2019
Last Updated
November 12, 2019
Sponsor
Cigdem Emirza
Collaborators
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03873688
Brief Title
Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis
Official Title
Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cigdem Emirza
Collaborators
Istanbul University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
expiratory muscle training, cough, respiratory muscle strength, exercise capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
expiratory muscle training
Intervention Description
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 Measure Information:
Title
Cough capacity
Description
peak expiratory flow meter
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Respiratory muscle strength
Description
maximal expiratory pressure, maximal inspiratory pressure
Time Frame
every two weeks
Title
Exercise capacity
Description
six minute walking test
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33421333
Citation
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.
Results Reference
derived
PubMed Identifier
33331663
Citation
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/23143864
Description
Related Info
URL
https://www.rehab.research.va.gov/jour/2014/514/pdf/JRRD-2013-03-0076.pdf
Description
Related Info
URL
http://rc.rcjournal.com/content/59/12/1912.short
Description
Related Info

Learn more about this trial

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

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