Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
28. července 2026 aktualizováno: Gulsah Bargi, Izmir Democracy University
Comparison of Nutritional Status and Sarcopenia Between Children and Adolescents With Primary Ciliary Dyskinesia and Healthy Children
To date, the literature has not yet elucidated the status of malnutrition and sarcopenia in children and adolescents with PCD compared to healthy controls.
Therefore, the aim of this study is to compare the nutritional and sarcopenia status of children and adolescents with primary ciliary dyskinesia to that of healthy controls.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
Primary ciliary dyskinesia (PCD) is an autosomal recessive disorder characterized by abnormal ciliary motility and impaired mucociliary clearance, caused by mutations in the genes responsible for ciliary movement.
Structural or functional defects of the cilia lead to chronic upper and lower respiratory tract infections, fertility issues, and organ asymmetry.
Activities of daily living predominantly consist of movements requiring short-term and repetitive anaerobic performance, and in children particularly, physical activities generally involve brief, low-to-moderate intensity exertion.
However, in children with PCD, factors such as pulmonary dysfunction, malnutrition, and decreased physical activity levels can adversely affect anaerobic exercise capacity.
Typ studie
Pozorovací
Zápis (Odhadovaný)
30
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Gülşah Barğı, Assoc Prof
- Telefonní číslo: +90 232 299 0739
- E-mail: gulsahbargi35@gmail.com
Studijní záloha kontaktů
- Jméno: Aybüke S Demir, PT, MSc
- Telefonní číslo: +90 543 215 0018
- E-mail: aybukedemir1108@gmail.com
Studijní místa
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Izmir, Turecko (Türkiye), 35140
- Izmir Democracy University
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Kontakt:
- Gülşah Barğı, Assoc Prof
- Telefonní číslo: +905317938766
- E-mail: gulsah.bargi@idu.edu.tr
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
At least 15 patients with primary ciliary dyskinesia will be included in the main group and at least 15 healthy individuals will be included in the control group.
Popis
Inclusion Criteria for Children and Adolescents with Primary Ciliary Dyskinesia:
- To be between the ages of 6-18
- To have been diagnosed with primary ciliary dyskinesia
- 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 primary ciliary dyskinesia 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 Primary Ciliary Dyskinesia:
- 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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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Kontrolní skupina
Tato skupina se bude skládat ze zdravých dětí a dospívajících.
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In this study, malnutrition and sarcopenia status in children and adolescents diagnosed with primary ciliary dyskinesia will be evaluated.
All data pertaining to these assessments will be acquired via face-to-face interviews with a duration of 45 to 60 minutes.
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Primary Ciliary Dyskinesia Group
This group will consist of children and adolescents with primary ciliary dyskinesia group.
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In this study, malnutrition and sarcopenia status in children and adolescents diagnosed with primary ciliary dyskinesia will be evaluated.
All data pertaining to these assessments will be acquired via face-to-face interviews with a duration of 45 to 60 minutes.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Hand Grip Strength
Časové okno: through study completion, an average of 1 year
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Handgrip strength (kg) will be assessed twice in each hand using a dynamometer (Jamar) with a maximal isometric contraction lasting approximately 2 seconds.
The best result (kg) will be used for data analysis.
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through study completion, an average of 1 year
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Vertical Jump Power
Časové okno: through study completion, an average of 1 year
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Vertical jump test, participants will assume a jumping position with their hands resting at the waist and their feet spaced pelvis-width apart.
Participants will perform one practice jump and three test jumps.
The highest of the three test jumps will be used for data analysis.
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through study completion, an average of 1 year
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Core muscle strength
Časové okno: through study completion, an average of 1 year
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Core muscle strength was assessed using the plank test (Plank, s) in which the body weight was supported by the toes and forearms.
The test was terminated when participants were unable to maintain posture or their pelvis moved up or down five or more cm, measured using a ruler.
The test was also ended if participants remained in the plank position for 3 minutes (highest score).
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through study completion, an average of 1 year
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Waist circumference measurement
Časové okno: through study completion, an average of 1 year
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Waist circumference measurement is the assessment of abdominal fat by measuring the distance around the narrowest part of the torso, usually just above the hip bones.
It is a simple indicator used to evaluate central obesity and the risk of metabolic and cardiovascular diseases.
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through study completion, an average of 1 year
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Malnutrition Risk Score of participants
Časové okno: through study completion, an average of 1 year
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Screening Tool for Risk on Nutritional Status and Growth will used to evaluate malnutrition risk score.
Total score of this tool ranges from 0 to 5; 0 shows low risk score while 5 shows high risk score.
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through study completion, an average of 1 year
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Body Fat Percentage
Časové okno: through study completion, an average of 1 year
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Body fat percentage is the proportion of fat mass compared to total body weight.
It is an important indicator of overall health and fitness, reflecting the balance between fat and lean body tissues.
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through study completion, an average of 1 year
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Forced Vital Capacity
Časové okno: through study completion, an average of 1 year
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Forced Vital Capacity will be measured via spirometry.
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through study completion, an average of 1 year
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Forced Expiratory Volume in 1 second
Časové okno: through study completion, an average of 1 year
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Forced Expiratory Volume in 1 second will be measured using spirometry.
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through study completion, an average of 1 year
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Forced Expiratory Volume in 1 second Forced Vital Capacity Ratio
Časové okno: through study completion, an average of 1 year
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This value will be measured using spirometry.
This ratio compares the amount of air exhaled in the first second to the total exhaled air.
It is used to differentiate between obstructive and restrictive lung disorders.
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through study completion, an average of 1 year
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Peak Expiratory Flow
Časové okno: through study completion, an average of 1 year
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This value will be measured using spirometry.
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through study completion, an average of 1 year
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Forced Expiratory Flow at 25-75%
Časové okno: through study completion, an average of 1 year
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This value will be measured using spirometry.
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through study completion, an average of 1 year
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Hip circumference measurement
Časové okno: through study completion, an average of 1 year
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Hip circumference measurement is the process of measuring the distance around the widest part of the hips and buttocks using a measuring tape.
It is commonly used to assess body fat distribution and calculate ratios like the waist-to-hip ratio.
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through study completion, an average of 1 year
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upper middle arm circumference measurement
Časové okno: through study completion, an average of 1 year
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Upper middle arm circumference (MUAC) measurement is the process of measuring the circumference of the upper arm at the midpoint between the shoulder and the elbow using a measuring tape.
It is commonly used to assess nutritional status, especially in children and adults in clinical or field settings.
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through study completion, an average of 1 year
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Triceps skinfold thickness
Časové okno: through study completion, an average of 1 year
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Triceps skinfold thickness is the measurement of the thickness of a fold of skin and subcutaneous fat at the back of the upper arm using calipers.
It is used to estimate body fat percentage and assess nutritional status.
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through study completion, an average of 1 year
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Gülşah Barğı, Assoc Prof, Izmir Democracy University
- Vrchní vyšetřovatel: Ece Ocak, Dr, İzmir City Hospital
- Vrchní vyšetřovatel: Aybüke S Demir, PT, MSc, Izmir Democracy University
- Vrchní vyšetřovatel: Kerim K Göküstün, Asst Prof, Izmir Democracy University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Denizoglu Kulli H, Gurses HN, Zeren M, Ucgun H, Cakir E. Do pulmonary and extrapulmonary features differ among cystic fibrosis, primary ciliary dyskinesia, and healthy children? Pediatr Pulmonol. 2020 Nov;55(11):3067-3073. doi: 10.1002/ppul.25052. Epub 2020 Sep 11.
- Firat M, Bosnak-Guclu M, Sismanlar-Eyuboglu T, Tana-Aslan A. Respiratory muscle strength, exercise capacity and physical activity in patients with primary ciliary dyskinesia: A cross-sectional study. Respir Med. 2022 Jan;191:106719. doi: 10.1016/j.rmed.2021.106719. Epub 2021 Dec 17.
- Baptista, F., Zymbal, V., & Janz, K. F. (2022). Predictive validity of handgrip strength, vertical jump power, and plank time in the identification of pediatric sarcopenia. Measurement in Physical Education and Exercise Science, 26(4), 361-370. https://doi.org/10.1080/1091367X.2021.1987242
- Goutaki M, Halbeisen FS, Spycher BD, Maurer E, Belle F, Amirav I, Behan L, Boon M, Carr S, Casaulta C, Clement A, Crowley S, Dell S, Ferkol T, Haarman EG, Karadag B, Knowles M, Koerner-Rettberg C, Leigh MW, Loebinger MR, Mazurek H, Morgan L, Nielsen KG, Phillipsen M, Sagel SD, Santamaria F, Schwerk N, Yiallouros P, Lucas JS, Kuehni CE; PCD Israeli Consortium; Swiss PCD Group; French Reference Centre for Rare Lung Diseases. Growth and nutritional status, and their association with lung function: a study from the international Primary Ciliary Dyskinesia Cohort. Eur Respir J. 2017 Dec 21;50(6):1701659. doi: 10.1183/13993003.01659-2017. Print 2017 Dec.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. srpna 2027
Dokončení studie (Odhadovaný)
1. srpna 2027
Termíny zápisu do studia
První předloženo
23. července 2026
První předloženo, které splnilo kritéria kontroly kvality
28. července 2026
První zveřejněno (Aktuální)
31. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
31. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Ciliopatie
- Neurologické projevy
- Nemoci nervového systému
- Neuromuskulární projevy
- Patologické stavy, anatomické
- Genetické choroby, vrozené
- Nemoci dýchacích cest
- Vrozené vady
- Otorinolaryngologická onemocnění
- Abnormality, vícenásobné
- Svalová atrofie
- Atrofie
- Vrozené, dědičné a neonatální nemoci a abnormality
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Poruchy ciliární motility
- Sarkopenie
Další identifikační čísla studie
- Sarcopenia in PCD
Plán pro data jednotlivých účastníků (IPD)
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Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .