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Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls

28 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

30

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Gruppo di controllo
Questo gruppo consisterà in bambini sani e adolescenti.
Altro: Physical Evaluations in Healthy Children
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.
Primary Ciliary Dyskinesia Group
This group will consist of children and adolescents with primary ciliary dyskinesia group.
Altro: Physical Evaluations in Children with Primary Ciliary Dyskinesia
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hand Grip Strength
Lasso di tempo: through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Vertical Jump Power
Lasso di tempo: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Core muscle strength
Lasso di tempo: through study completion, an average of 1 year
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).
through study completion, an average of 1 year
Waist circumference measurement
Lasso di tempo: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Malnutrition Risk Score of participants
Lasso di tempo: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Body Fat Percentage
Lasso di tempo: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Forced Vital Capacity
Lasso di tempo: through study completion, an average of 1 year
Forced Vital Capacity will be measured via spirometry.
through study completion, an average of 1 year
Forced Expiratory Volume in 1 second
Lasso di tempo: through study completion, an average of 1 year
Forced Expiratory Volume in 1 second will be measured using spirometry.
through study completion, an average of 1 year
Forced Expiratory Volume in 1 second Forced Vital Capacity Ratio
Lasso di tempo: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Peak Expiratory Flow
Lasso di tempo: through study completion, an average of 1 year
This value will be measured using spirometry.
through study completion, an average of 1 year
Forced Expiratory Flow at 25-75%
Lasso di tempo: through study completion, an average of 1 year
This value will be measured using spirometry.
through study completion, an average of 1 year
Hip circumference measurement
Lasso di tempo: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
upper middle arm circumference measurement
Lasso di tempo: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Triceps skinfold thickness
Lasso di tempo: through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Izmir Democracy University

Investigatori

  • Direttore dello studio: Gülşah Barğı, Assoc Prof, Izmir Democracy University
  • Investigatore principale: Ece Ocak, Dr, İzmir City Hospital
  • Investigatore principale: Aybüke S Demir, PT, MSc, Izmir Democracy University
  • Investigatore principale: Kerim K Göküstün, Asst Prof, Izmir Democracy University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

23 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 luglio 2026

Primo Inserito (Effettivo)

31 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Sarcopenia in PCD

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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