Clinical trial NCT06984679: Physical Impairments in Children With Cystic Fibrosis
Official title: Comparison of Dyspnea, Functional Capacity, Muscle Strength, Urinary Incontinence and Quality of Life Between Children and Adolescents With Cystic Fibrosis and Healthy Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cystic Fibrosis (CF)
Cystic Fibrosis in Children
Keywords: Cystic Fibrosis
Urinary Incontinence
Dyspnea
Muscle Strength
Quality of Life
Exercise Test
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 25 patients with cystic fibrosis will be included in the main group and at least 25 healthy individuals will be included in the control group.

Brief summary: It is aimed to reveal impairments regarding urinary incontinence, dyspnea, muscle strength, functional capacity or quality of life in children and adolescents with cystic fibrosis compared to healthy children and adolescents.

Detailed description: This study aims to compare dyspnea, functional capacity, muscle strength, urinary incontinence and quality of life between children and adolescents with cystic fibrosis and healthy children and adolescents. Participants will be assessed for these parameters through clinical evaluations, exercise tests, questionnaires and measurements. The study aims to understand the health implications of cystic fibrosis and provide the basis for improvements in the health management of these individuals.

Eligibility criteria: Inclusion Criteria for Children and Adolescents with Cystic Fibrosis:

* To be between the ages of 6-18
* To have been diagnosed with cystic fibrosis
* To be clinically stable for at least 3 weeks
* To have the necessary cooperation for the measurements
* To volunteer to participate in the study

Inclusion Criteria for Healthy Children and Adolescents:

* To be between the ages of 6-18
* To be in a similar average and ratio with the group of children and adolescents with cystic fibrosis in terms of age and gender
* To have the necessary cooperation for the measurements
* To volunteer to participate in the study

Exclusion Criteria for Children and Adolescents with Cystic Fibrosis:

* Having any orthopedic, neurological, psychological or cardiovascular problem that may prevent the measurements from being performed in the last 6 months
* Smoking or quitting smoking

Exclusion Criteria for Healthy Children and Adolescents:

* Having any orthopedic, neurological, psychological or cardiovascular problem that may prevent the measurements from being performed in the last 6 months
* Having any chronic disease
* Smoking or quitting smoking

Primary outcomes:
measure: Hand Grip Strength
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Dyspnea score
timeFrame: through study completion, an average of 1 year
measure: Pulmonary Function Test Evaluation
timeFrame: through study completion, an average of 1 year
measure: Respiratory Muscle Strength Evaluation
timeFrame: through study completion, an average of 1 year
measure: Cough Strength Evaluation
timeFrame: through study completion, an average of 1 year
measure: Aerobic Exercise Capacity Evaluation
timeFrame: through study completion, an average of 1 year
measure: Anaerobic Exercise Capacity Evaluation
timeFrame: through study completion, an average of 1 year
measure: Quality of Life Score
timeFrame: through study completion, an average of 1 year
measure: Urinary incontinence score
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Democracy University
Study officials:
affiliation: Izmir Democracy University
name: Gülşah Barğı, Assoc Prof
role: STUDY_DIRECTOR
affiliation: Izmir Democracy University
name: Yağmur Külekçi, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Gökçen Kartal Öztürk, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir City Hospital
name: Ece Ocak, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Kübra Özkaya, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tuğay, B. U., Arıkan, H., & Özçelik, U. (2004). Kistik fibrozisli çocuklarda pulmoner fonksiyonlar ve vücut kompozisyonu ile kas kuvveti arasındaki ilişki. Fizyoterapi ve Rehabilitasyon, 15(2), 47-54.
citation: Frayman KB, Kazmerski TM, Sawyer SM. A systematic review of the prevalence and impact of urinary incontinence in cystic fibrosis. Respirology. 2018 Jan;23(1):46-54. doi: 10.1111/resp.13125. Epub 2017 Jul 18.
citation: Heron J, Grzeda MT, von Gontard A, Wright A, Joinson C. Trajectories of urinary incontinence in childhood and bladder and bowel symptoms in adolescence: prospective cohort study. BMJ Open. 2017 Mar 14;7(3):e014238. doi: 10.1136/bmjopen-2016-014238.