Muscle Endurance in Children With Cystic Fibrosis

Recruiting

• Conditions: Cystic Fibrosis

• Registration Number: NCT06812793
• Lead Sponsor: Bezmialem Vakif University

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.

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study Start: 2025-02-05
• Study First Posted: 2025-02-06
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-04-04
• Study Completion: 2025-05-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Core muscles endurance	Baseline	Endurance of the flexor, extensor and lateral trunk muscles will be assessed using the McGill Trunk Endurance Tests.

Secondary Outcome Measures

Name	Time	Method
Respiratory Muscle Strength	Baseline	Inspiratory and expiratory muscle strength will be made with a portable, electronic intra-oral pressure measuring device.
Respiratory muscle endurance	Baseline	Respiratory muscle endurance testing will be measured using an inspiratory muscle training device at increasing threshold load.
Peripheral muscle endurance	Baseline	Peripheral muscle endurance will be assessed by performing 30 and 60 second sit-to-stand tests.

Trial Locations

Locations (2)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey