Muscle Endurance in Children With Cystic Fibrosis

NCT06812793 | Completed

• 1 other identifier: bvubcinar02
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Core muscles endurance

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

  Baseline

Secondary Outcomes (3)

• Respiratory Muscle Strength

  Baseline

• Respiratory muscle endurance

  Baseline

• Peripheral muscle endurance

  Baseline

Study Arms (2)

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

Measurement of Core Muscle Endurance OTHER

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

Children with cystic fibrosis; Healthy children

Respiratory Muscle Strength OTHER

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

Children with cystic fibrosis; Healthy children

Respiratory Muscle Endurance OTHER

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

Children with cystic fibrosis; Healthy children

Peripheral Muscle Endurance OTHER

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

Children with cystic fibrosis; Healthy children

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• \- Being between the ages of 6-18
• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PhD

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 6, 2025
• Study Start: February 5, 2025
• Primary Completion: November 3, 2025
• Study Completion: December 29, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)