CClinicalTrials.gg
CompletedNCT06812793Updated Jan 6, 2026

Muscle Endurance in Children With Cystic Fibrosis

An observational study in Cystic Fibrosis, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Bezmialem Vakif University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
48
Ages
6 Years to 18 Years
Sex
All
01

Study summary

Cystic fibrosis (CF) is a genetic disorder affecting exocrine glands, leading to thick, viscous secretions that damage organs such as the lungs, pancreas, and reproductive system. Respiratory failure from CF lung disease is a major cause of morbidity and mortality, with chronic inflammation and infections disrupting mucociliary clearance. This results in declining respiratory functions, muscle strength, physical inactivity, and quality of life. While some studies compare respiratory and lower extremity muscle endurance in children with CF, none have evaluated core muscle endurance. This study aims to compare respiratory muscle strength, endurance, and muscle endurance in the core and lower extremities between children with CF and healthy peers.

Read the detailed description

Cystic fibrosis (CF) is an autosomal recessive genetic disease characterized by the involvement of exocrine glands, resulting from a disorder in the synthesis or function of the Cystic Fibrosis Transmembrane Regulator (CFTR) protein. The CFTR protein is responsible for ion and water transport in the cell epithelium. Dysfunction of this protein causes the secretion produced to be deficient in water. Viscous secretion, which is difficult to remove from its environment, causes permanent damage to many organs and systems such as the lungs, pancreas, hepatobiliary system and reproductive system. Respiratory failure due to CF lung disease is the most important cause of morbidity and mortality. The basic mechanism in the pathophysiology of CF lung disease is chronic inflammation and recurrent infections that occur as a result of the disruption of mucociliary clearance by sticky secretions. This vicious cycle causes obstruction in the airways and leads to progressive losses in respiratory functions. The decrease in respiratory functions; loss of muscle strength, reduced functional capacity, physical inactivity and reduced quality of life. There are limited studies in the literature comparing the respiratory muscle strength, respiratory muscle endurance and lower extremity muscle endurance of children with CF with their healthy peers. However, there is no study evaluating the core muscle endurance of children with CF. This study aims to compare the respiratory muscle strength, respiratory muscle endurance, core muscle endurance and lower extremity muscle endurance in children with CF and their healthy peers.

02

Conditions studied

  • Cystic Fibrosis

Browse trials for

Keywords

  • Pediatric chest diseases
  • core muscle endurance
  • respiratory muscles
  • sit-to-stand test
03

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 48 is below the median of 85 across 482 observational studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.

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

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children diagnosed with cystic fibrosis and age matched healthy volunteers who do not have any diagnosed chronic diseases

Inclusion Criteria for Children with Cystic Fibrosis

  • Being between the ages of 6-18,
  • Being diagnosed with Cystic Fibrosis according to the American Cystic Fibrosis Association consensus guideline,
  • Having a forced expiratory volume in one second (FEV1) above 40% of the predicted value

Exclusion Criteria for Children with Cystic Fibrosis

  • Not being able to cooperate with the assessment methods performed in the study
  • Having an orthopedic, neurological, vestibular, etc. problem that may negatively affect the assessment methods performed in the study
  • Having a history of exacerbation in the last month
  • Having an organ transplantation history
  • Using systemic corticosteroids

Inclusion criteria

Inclusion Criteria for Healthy Children

- Being between the ages of 6-18

Exclusion criteria

Exclusion Criteria for Healthy Children

  • Not being able to cooperate with the assessment methods performed in the study
  • Having an orthopedic, neurological, vestibular, etc. problem that may negatively affect the assessment methods performed in the study
  • Having had a respiratory tract infection in the last month
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
48 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Children with cystic fibrosis

    Children diagnosed cystic fibrosis

    Other: Measurement of Core Muscle Endurance · Other: Respiratory Muscle Strength · Other: Respiratory Muscle Endurance · Other: Peripheral Muscle Endurance

  • Healthy children

    Age-matched healthy volunteers

    Other: Measurement of Core Muscle Endurance · Other: Respiratory Muscle Strength · Other: Respiratory Muscle Endurance · Other: Peripheral Muscle Endurance

Interventions

  • OtherMeasurement of Core Muscle Endurance

    Endurance of the flexor, extensor and lateral trunk muscles will be assessed using the McGill Trunk Endurance Tests.

  • OtherRespiratory Muscle Strength

    Inspiratory and expiratory muscle strength will be made with a portable, electronic intra-oral pressure measuring device.

  • OtherRespiratory Muscle Endurance

    Respiratory muscle endurance testing will be measured using an inspiratory muscle training device at increasing threshold load.

  • OtherPeripheral Muscle Endurance

    Peripheral muscle endurance will be assessed by performing 30 and 60 second sit-to-stand tests.

06

What researchers measure

Primary outcomes

  1. Core muscles endurance

    Endurance of the flexor, extensor and lateral trunk muscles will be assessed using the McGill Trunk Endurance Tests.

    Time frame: Baseline

Secondary outcomes

  1. Respiratory Muscle Strength

    Inspiratory and expiratory muscle strength will be made with a portable, electronic intra-oral pressure measuring device.

    Time frame: Baseline

  2. Respiratory muscle endurance

    Respiratory muscle endurance testing will be measured using an inspiratory muscle training device at increasing threshold load.

    Time frame: Baseline

  3. Peripheral muscle endurance

    Peripheral muscle endurance will be assessed by performing 30 and 60 second sit-to-stand tests.

    Time frame: Baseline

07

Study locations

1 site
  • Bezmialem Vakif University
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06812793
Lead sponsor
Bezmialem Vakif University
Responsible party
Betül Çınar (Lecturer, PhD, Bezmialem Vakif University) — Principal investigator
First posted
Feb 6, 2025
Start date
Feb 5, 2025
Primary completion
Nov 3, 2025
Completion
Dec 29, 2025
Last update
Jan 6, 2026

Oversight

Data monitoring committee
No
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 Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion