Physical Impairments in Children With Cystic Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Evaluations in Children with Cystic Fibrosis, Physical Evaluations in Healthy Children.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis (CF), Cystic Fibrosis in Children. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other 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. - 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.
Primary outcome measures
- Hand Grip Strength [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (8)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Izmir Democracy University — Izmir
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. PMID 28718995
- 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. PMID 28292756
Identifiers
NCT: NCT06984679 · Healthy and Cystic Fibrosis