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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cystic Fibrosis Group | This group will consist of children and adolescents with cystic fibrosis. |
| |
| Control Group | This group will consist of healthy children and adolescents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Evaluations in Children with Cystic Fibrosis | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea score | Dyspnea will be assessed with the Modified Medical Research Council (MMRC) Dyspnea Scale, scored from 0 (no dyspnea) to 4 (maximum severity). | through study completion, an average of 1 year |
| Pulmonary Function Test Evaluation |
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Inclusion Criteria for Children and Adolescents with Cystic Fibrosis:
Inclusion Criteria for Healthy Children and Adolescents:
Exclusion Criteria for Children and Adolescents with Cystic Fibrosis:
Exclusion Criteria for Healthy Children and Adolescents:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gülşah Barğı, Assoc Prof | Contact | +90 232 299 0739 | gulsahbargi35@gmail.com | |
| Yağmur Külekçi, PT | Contact | +90 533 661 4001 | yagmurkulekci1401@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gülşah Barğı, Assoc Prof | Izmir Democracy University | Study Director |
| Yağmur Külekçi, PT | Izmir Democracy University | Principal Investigator |
| Gökçen Kartal Öztürk, Assoc Prof |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Democracy University | Recruiting | Izmir | 35140 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 28718995 | 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. | |
| 28292756 |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D014549 | Urinary Incontinence |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| Physical Evaluations in Healthy Children | 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. |
|
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.
| 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. | 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. | 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. | 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. | 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. | 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. | through study completion, an average of 1 year |
| Ege University |
| Principal Investigator |
| Ece Ocak, Dr | Izmir City Hospital | Principal Investigator |
| Kübra Özkaya, Dr | Ege University | Principal Investigator |
| Background |
| 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. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |