Physical function and symptoms 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
This project will compare breathing difficulty, exercise capacity, muscle strength, bladder control, and quality of life in children aged 6–18 with cystic fibrosis versus healthy peers to see where support is needed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Izmir Democracy University Academic / other |
| Locations | 1 site (Izmir) |
| Trial ID | NCT06984679 on ClinicalTrials.gov |
What this trial studies
This observational study compares dyspnea, functional capacity, muscle strength, urinary incontinence, and quality of life between children and adolescents with cystic fibrosis and age- and gender-matched healthy peers. Participants aged 6–18 will undergo clinical evaluations, exercise tests, physical measurements, and standardized questionnaires. Data will be collected at Izmir Democracy University and analyzed to identify differences in physical impairments and symptom burden. Results are intended to inform health management and rehabilitation priorities for children with cystic fibrosis.
Who should consider this trial
Good fit: Children and adolescents aged 6–18 with a confirmed diagnosis of cystic fibrosis who are clinically stable for at least three weeks and able to cooperate with testing are ideal candidates.
Not a fit: Children who are not clinically stable, have recent orthopedic, neurological, psychological, or cardiovascular problems, cannot cooperate with tests, or are current/former smokers are unlikely to be included or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could identify specific physical or symptom areas to target with therapy and rehabilitation to improve daily functioning and quality of life for children with CF.
How similar studies have performed: Previous observational studies have reported reduced exercise capacity and muscle strength in children with CF and have helped guide rehabilitation, so the basic approach is established though local data may be limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Izmir
- Izmir Democracy University — Izmir, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Yağmur Külekçi, PT — Izmir Democracy University
- Study coordinator: Gülşah Barğı, Assoc Prof
- Email: gulsahbargi35@gmail.com
- Phone: +90 232 299 0739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.