NCT03873688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

10 months

First QC Date

March 12, 2019

Last Update Submit

November 12, 2019

Conditions

Cystic Fibrosis

Keywords

expiratory muscle trainingcoughrespiratory muscle strengthexercise capacity

Outcome Measures

Primary Outcomes (1)

  • Cough capacity

    peak expiratory flow meter

    6 weeks

Secondary Outcomes (2)

  • Respiratory muscle strength

    every two weeks

  • Exercise capacity

    6 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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 Group

SHAM COMPARATOR

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

expiratory muscle trainingOTHER

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.

Experimental GroupSham Group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 33421333DERIVED

  • 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.

    PMID: 33331663DERIVED

Related Links

MeSH Terms

Conditions

Cystic FibrosisCough

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 13, 2019

Study Start

January 2, 2019

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)