Cystic Fibrosis (CF), Cystic Fibrosis in Children
Conditions
Keywords
Cystic Fibrosis, Urinary Incontinence, Dyspnea, Muscle Strength, Quality of Life, Exercise Test
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.
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
OTHERPhysical 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.
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.
Sponsors
Izmir Democracy University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand Grip Strength | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea score | through study completion, an average of 1 year | Dyspnea will be assessed with the Modified Medical Research Council (MMRC) Dyspnea Scale, scored from 0 (no dyspnea) to 4 (maximum severity). |
| Pulmonary Function Test Evaluation | through study completion, an average of 1 year | 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. |
| Respiratory Muscle Strength Evaluation | through study completion, an average of 1 year | 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. |
| Cough Strength Evaluation | through study completion, an average of 1 year | 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. |
| Aerobic Exercise Capacity Evaluation | through study completion, an average of 1 year | 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. |
| Anaerobic Exercise Capacity Evaluation | through study completion, an average of 1 year | 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. |
| Quality of Life Score | through study completion, an average of 1 year | 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. |
| Urinary incontinence score | through study completion, an average of 1 year | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTGülşah Barğı, Assoc Prof
CONTACTYağmur Külekçi, PT
STUDY_DIRECTORGülşah Barğı, Assoc Prof
Izmir Democracy University
PRINCIPAL_INVESTIGATORYağmur Külekçi, PT
Izmir Democracy University
PRINCIPAL_INVESTIGATORGökçen Kartal Öztürk, Assoc Prof
Ege University
PRINCIPAL_INVESTIGATOREce Ocak, Dr
Izmir City Hospital
PRINCIPAL_INVESTIGATORKübra Özkaya, Dr
Ege University
Outcome results
None listed