Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
28. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
30
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Gülşah Barğı, Assoc Prof
- Telefonnummer: +90 232 299 0739
- E-mail: gulsahbargi35@gmail.com
Undersøgelse Kontakt Backup
- Navn: Aybüke S Demir, PT, MSc
- Telefonnummer: +90 543 215 0018
- E-mail: aybukedemir1108@gmail.com
Studiesteder
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Izmir, Tyrkiet (Türkiye), 35140
- Izmir Democracy University
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Kontakt:
- Gülşah Barğı, Assoc Prof
- Telefonnummer: +905317938766
- E-mail: gulsah.bargi@idu.edu.tr
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Kontrolgruppe
Denne gruppe vil bestå af sunde børn og unge.
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hand Grip Strength
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Vertical Jump Power
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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%
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Gülşah Barğı, Assoc Prof, Izmir Democracy University
- Ledende efterforsker: Ece Ocak, Dr, İzmir City Hospital
- Ledende efterforsker: Aybüke S Demir, PT, MSc, Izmir Democracy University
- Ledende efterforsker: Kerim K Göküstün, Asst Prof, Izmir Democracy University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. august 2027
Studieafslutning (Anslået)
1. august 2027
Datoer for studieregistrering
Først indsendt
23. juli 2026
Først indsendt, der opfyldte QC-kriterier
28. juli 2026
Først opslået (Faktiske)
31. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Ciliopatier
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Neuromuskulære manifestationer
- Patologiske Tilstande, Anatomiske
- Genetiske sygdomme, medfødte
- Luftvejssygdomme
- Medfødte abnormiteter
- Otorhinolaryngologiske sygdomme
- Abnormiteter, multiple
- Muskelatrofi
- Atrofi
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Ciliære motilitetsforstyrrelser
- Sarkopeni
Andre undersøgelses-id-numre
- Sarcopenia in PCD
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