Physical Impairments in Children With Cystic Fibrosis
Comparison of Dyspnea, Functional Capacity, Muscle Strength, Urinary Incontinence and Quality of Life Between Children and Adolescents With Cystic Fibrosis and Healthy Children
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2025
CompletedFirst Posted
Study publicly available on registry
May 22, 2025
CompletedStudy Start
First participant enrolled
September 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 3, 2027
March 27, 2026
March 1, 2026
1.5 years
May 14, 2025
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hand Grip Strength
Grip strength will be measured using a dynamometer. Each hand will be tested three times, and the highest value will be recorded for both sides.
through study completion, an average of 1 year
Secondary Outcomes (8)
Dyspnea score
through study completion, an average of 1 year
Pulmonary Function Test Evaluation
through study completion, an average of 1 year
Respiratory Muscle Strength Evaluation
through study completion, an average of 1 year
Cough Strength Evaluation
through study completion, an average of 1 year
Aerobic Exercise Capacity Evaluation
through study completion, an average of 1 year
- +3 more secondary outcomes
Study Arms (2)
Cystic Fibrosis Group
This group will consist of children and adolescents with cystic fibrosis.
Control Group
This group will consist of healthy children and adolescents.
Interventions
In this study, dyspnea, functional capacity, muscle strength, urinary incontinence and quality of life will be evaluated in healthy children and adolescents. The data to be obtained from all these assessments will be made face to face within 45-60 minutes.
In this study, dyspnea, functional capacity, muscle strength, urinary incontinence and quality of life will be evaluated in children and adolescents with cystic fibrosis. The data to be obtained through all these evaluations will be done face to face within 45-60 minutes.
Eligibility Criteria
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.
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Izmir Democracy University
Izmir, 35140, Turkey (Türkiye)
Related Publications (3)
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.
BACKGROUNDFrayman 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.
PMID: 28718995BACKGROUNDHeron 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.
PMID: 28292756BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gülşah Barğı, Assoc Prof
Izmir Democracy University
- PRINCIPAL INVESTIGATOR
Yağmur Külekçi, PT
Izmir Democracy University
- PRINCIPAL INVESTIGATOR
Gökçen Kartal Öztürk, Assoc Prof
Ege University
- PRINCIPAL INVESTIGATOR
Ece Ocak, Dr
Izmir City Hospital
- PRINCIPAL INVESTIGATOR
Kübra Özkaya, Dr
Ege University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 14, 2025
First Posted
May 22, 2025
Study Start
September 15, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 3, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share