Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls

NCT07740551 | Not Yet Recruiting

• 1 other identifier: Sarcopenia in PCD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Ciliary Dyskinesia (PCD)

Keywords

primary ciliary dyskinesia (PCD); sarcopenia; respiratory function test; malnutrion

Outcome Measures

Primary Outcomes (1)

• Hand Grip Strength

  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

Secondary Outcomes (13)

• Vertical Jump Power

  through study completion, an average of 1 year

• Core muscle strength

  through study completion, an average of 1 year

• Waist circumference measurement

  through study completion, an average of 1 year

• Malnutrition Risk Score of participants

  through study completion, an average of 1 year

• Body Fat Percentage

  through study completion, an average of 1 year

Study Arms (2)

Primary Ciliary Dyskinesia Group

This group will consist of children and adolescents with primary ciliary dyskinesia group.

Other: Physical Evaluations in Children with Primary Ciliary Dyskinesia

Control Group

This group will consist of healthy children and adolescents.

Other: Physical Evaluations in Healthy Children

Interventions

Physical Evaluations in Children with Primary Ciliary Dyskinesia OTHER

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

Physical Evaluations in Healthy Children OTHER

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.

Control Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

Location

Related Publications (4)

• 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

  BACKGROUND

• 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.

  PMID: 29269581 BACKGROUND

• 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.

  PMID: 32877003 BACKGROUND

• 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.

  PMID: 34952415 BACKGROUND

MeSH Terms

Conditions

Ciliary Motility Disorders; Sarcopenia

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Gülşah Barğı, Assoc Prof

  Izmir Democracy University

  STUDY DIRECTOR

• Aybüke S Demir, PT, MSc

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Kerim K Göküstün, Asst Prof

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Ece Ocak, Dr

  Izmir City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülşah Barğı, Assoc Prof

CONTACT

+90 232 299 0739; gulsahbargi35@gmail.com

Aybüke S Demir, PT, MSc

CONTACT

+90 543 215 0018; aybukedemir1108@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)