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Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls

28. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

30

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Kontrollgruppe
Diese Gruppe wird aus gesunden Kindern und Jugendlichen bestehen.
Sonstiges: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hand Grip Strength
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Vertical Jump Power
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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%
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Izmir Democracy University

Ermittler

  • Studienleiter: Gülşah Barğı, Assoc Prof, Izmir Democracy University
  • Hauptermittler: Ece Ocak, Dr, İzmir City Hospital
  • Hauptermittler: Aybüke S Demir, PT, MSc, Izmir Democracy University
  • Hauptermittler: Kerim K Göküstün, Asst Prof, Izmir Democracy University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. August 2027

Studienabschluss (Geschätzt)

1. August 2027

Studienanmeldedaten

Zuerst eingereicht

23. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juli 2026

Zuerst gepostet (Tatsächlich)

31. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Sarcopenia in PCD

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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