Physical Impairments in Children With Cystic Fibrosis

NCT ID: NCT06984679

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-15

Study Completion Date

2027-03-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis (CF) Cystic Fibrosis in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cystic Fibrosis Group

This group will consist of children and adolescents with cystic fibrosis.

Physical Evaluations in Children with Cystic Fibrosis

Intervention Type OTHER

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.

Control Group

This group will consist of healthy children and adolescents.

Physical Evaluations in Healthy Children

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical Evaluations in Children with Cystic Fibrosis

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.

Intervention Type OTHER

Physical Evaluations in Healthy Children

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Izmir Democracy University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gulsah Bargi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gülşah Barğı, Assoc Prof

Role: STUDY_DIRECTOR

Izmir Democracy University

Yağmur Külekçi, PT

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Gökçen Kartal Öztürk, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Ege University

Ece Ocak, Dr

Role: PRINCIPAL_INVESTIGATOR

Izmir City Hospital

Kübra Özkaya, Dr

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Izmir Democracy University

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gülşah Barğı, Assoc Prof

Role: CONTACT

+90 232 299 0739

Yağmur Külekçi, PT

Role: CONTACT

+90 533 661 4001

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gülşah Barğı, Assoc Prof

Role: primary

+905317938766

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 28718995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28292756 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Healthy and Cystic Fibrosis

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.