Muscle Endurance in Children With Cystic Fibrosis

NCT ID: NCT06812793

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2025-12-29

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.

Conditions

Cystic Fibrosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Children with cystic fibrosis

Children diagnosed cystic fibrosis

Measurement of Core Muscle Endurance

Intervention Type: OTHER

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

Respiratory Muscle Strength

Intervention Type: OTHER

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

Respiratory Muscle Endurance

Intervention Type: OTHER

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

Peripheral Muscle Endurance

Intervention Type: OTHER

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

Healthy children

Age-matched healthy volunteers

Measurement of Core Muscle Endurance

Intervention Type: OTHER

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

Respiratory Muscle Strength

Intervention Type: OTHER

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

Respiratory Muscle Endurance

Intervention Type: OTHER

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

Peripheral Muscle Endurance

Intervention Type: OTHER

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

Interventions

Measurement of Core Muscle Endurance

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

Intervention Type: OTHER

Respiratory Muscle Strength

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

Intervention Type: OTHER

Respiratory Muscle Endurance

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

Intervention Type: OTHER

Peripheral Muscle Endurance

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Being between the ages of 6-18

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Betül Çınar

Lecturer, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

bvubcinar02

Identifier Type: -

Identifier Source: org_study_id