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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873688
• Other study ID #: TYL-2018-31769
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: November 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Cigdem Emirza	Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough capacity	peak expiratory flow meter	6 weeks
Secondary	Respiratory muscle strength	maximal expiratory pressure, maximal inspiratory pressure	every two weeks
Secondary	Exercise capacity	six minute walking test	6 weeks

External Links

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