Cystic Fibrosis (CF)NCT06984679
Physical Impairments in Children With Cystic Fibrosis
An observational study of Cystic Fibrosis (CF) and Cystic Fibrosis in Children, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cystic Fibrosis (CF), Cystic Fibrosis in Children
- What is being tested?
- Physical Evaluations in Children with Cystic Fibrosis and Physical Evaluations in Healthy Children
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 3 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Democracy University
Izmir, 35140
Gülşah Barğı, Assoc Prof, +905317938766, gulsah.bargi@idu.edu.tr
About this study
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
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.
Read the 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.
- Conditions
- Cystic Fibrosis (CF), Cystic Fibrosis in Children
- Being tested
- Physical Evaluations in Children with Cystic Fibrosis, Physical Evaluations in Healthy Children
- Keywords
- Cystic Fibrosis, Urinary Incontinence, Dyspnea, Muscle Strength, Quality of Life, Exercise Test
- Medical subject headings
- Cystic Fibrosis, Urinary Incontinence, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Evaluations in Children with Cystic FibrosisOther
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.
Physical Evaluations in Healthy ChildrenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis Group | This group will consist of children and adolescents with cystic fibrosis. Receives: Other: Physical Evaluations in Children with Cystic Fibrosis | |
| Control Group | This group will consist of healthy children and adolescents. Receives: Other: Physical Evaluations in Healthy Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Dyspnea score
Dyspnea will be assessed with the Modified Medical Research Council (MMRC) Dyspnea Scale, scored from 0 (no dyspnea) to 4 (maximum severity).
Measured: through study completion, an average of 1 year
Pulmonary Function Test Evaluation
Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height. A value below 80% of the expected value will be interpreted as abnormal.
Measured: through study completion, an average of 1 year
Respiratory Muscle Strength Evaluation
Respiratory muscle strength will be assessed with a spirometer. The test will be conducted with the participant seated, using a mouthpiece and a nose clip. The highest value for inspiratory and expiratory pressure will be recorded. A value below 80% of the expected value will be interpreted as abnormal.
Measured: through study completion, an average of 1 year
Cough Strength Evaluation
The peak cough expiratory flow of the individual will be assessed using a peak flow meter. The best of at least three repetitions is recorded.A value above 450 indicates effective cough.
Measured: through study completion, an average of 1 year
Aerobic Exercise Capacity Evaluation
Aerobic capacity will be assessed twice via 6-minute walk test. The longest distance will be used for analysis. A value below 80% of the expected value will be interpreted as abnormal.
Measured: through study completion, an average of 1 year
Anaerobic Exercise Capacity Evaluation
Anaerobic capacity will be assessed via the 3-minute step test (3-STT). For the 3-STT, participants will rest for 10 minutes before performing the test with a 15 cm step at a rate of 30 steps per minute, controlled by a metronome. The total number of steps will be recorded.A high number of steps indicates good capacity.
Measured: through study completion, an average of 1 year
Quality of Life Score
The scale we will use to assess health-related quality of life, the Pediatric Quality of Life Inventory (PedsQL 4.0). The scale was developed to assess the health-related quality of life of children and adolescents between the ages of 2 and 18 and consists of physical, emotional, social and school functioning items, totaling 23 items.Scores from this questionnaire are converted to a scale of 0 to 100. Higher scores indicate better health-related quality of life.
Measured: through study completion, an average of 1 year
Urinary incontinence score
Urinary incontinence will be assessed using the Voiding Dysfunction Symptom Score, a 15-item questionnaire. A score above 8.5 indicates the presence of lower urinary tract symptoms.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start15 Sep 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion3 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Bargi, Izmir Democracy University
- Investigators
- Gülşah Barğı, Assoc Prof, Study director, Izmir Democracy UniversityYağmur Külekçi, PT, Principal investigator, Izmir Democracy UniversityGökçen Kartal Öztürk, Assoc Prof, Principal investigator, Ege UniversityEce Ocak, Dr, Principal investigator, Izmir City HospitalKübra Özkaya, Dr, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984679
- Sponsor's protocol ID
- Healthy and Cystic Fibrosis
- Status last verified
- Mar 2026
- First submitted
- 14 May 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 28718995Heron 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.
PubMed 28292756
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06984679
- Acronym / sponsor ID
- Healthy and Cystic Fibrosis
- Conditions
- Cystic Fibrosis (CF), Cystic Fibrosis in Children
- Keywords
- Cystic Fibrosis, Urinary Incontinence, Dyspnea, Muscle Strength, Quality of Life, Exercise Test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 3 Mar 2027 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis Group | – | Other: Physical Evaluations in Children with Cystic FibrosisThis group will consist of children and adolescents with cystic fibrosis. |
| Control Group | – | Other: Physical Evaluations in Healthy ChildrenThis group will consist of healthy children and adolescents. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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
- Having any orthopedic, neurological, psychological or cardiovascular problem that may prevent the measurements from being performed in the last 6 months
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Evaluations in Children with Cystic FibrosisIn 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. | Other | Cystic Fibrosis Group |
| Physical Evaluations in Healthy ChildrenIn 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. | Other | Control Group |
Primary outcome
Hand Grip Strength
Time frame: through study completion, an average of 1 year
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.
8 secondary outcomes
Dyspnea score
Time frame: through study completion, an average of 1 year
Pulmonary Function Test Evaluation
Time frame: through study completion, an average of 1 year
Respiratory Muscle Strength Evaluation
Time frame: through study completion, an average of 1 year
Cough Strength Evaluation
Time frame: through study completion, an average of 1 year
Aerobic Exercise Capacity Evaluation
Time frame: through study completion, an average of 1 year
Anaerobic Exercise Capacity Evaluation
Time frame: through study completion, an average of 1 year
Quality of Life Score
Time frame: through study completion, an average of 1 year
Urinary incontinence score
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- BackgroundTuğay, 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.
- Background: PubMed 28718995Frayman 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.
- Background: PubMed 28292756Heron 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gülşah Barğı, Assoc Prof study director
Izmir Democracy University
Yağmur Külekçi, PT principal investigator
Izmir Democracy University
Gökçen Kartal Öztürk, Assoc Prof principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis (CF) and Cystic Fibrosis in Children, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gülşah Barğı, Assoc Prof (+90 232 299 0739, gulsahbargi35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Grip Strength (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06984679, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.