Primary Ciliary Dyskinesia (PCD)NCT07740551
Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
An observational study of Primary Ciliary Dyskinesia (PCD), run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Ciliary Dyskinesia (PCD)
- What is being tested?
- Physical Evaluations in Children with Primary Ciliary Dyskinesia and Physical Evaluations in Healthy Children
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2026to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Democracy University
Izmir, 35140
Gülşah Barğı, Assoc Prof, +905317938766, gulsah.bargi@idu.edu.tr
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Primary Ciliary Dyskinesia (PCD)
- Being tested
- Physical Evaluations in Children with Primary Ciliary Dyskinesia, Physical Evaluations in Healthy Children
- Keywords
- primary ciliary dyskinesia (PCD), sarcopenia, respiratory function test, malnutrion
- Medical subject headings
- Ciliary Motility Disorders, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Evaluations in Children with Primary Ciliary DyskinesiaOther
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.
Physical Evaluations in Healthy ChildrenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary Ciliary Dyskinesia Group | This group will consist of children and adolescents with primary ciliary dyskinesia group. Receives: Other: Physical Evaluations in Children with Primary Ciliary Dyskinesia | |
| Control Group | This group will consist of healthy children and adolescents. Receives: Other: Physical Evaluations in Healthy Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (13)
Vertical Jump Power
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.
Measured: through study completion, an average of 1 year
Core muscle strength
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).
Measured: through study completion, an average of 1 year
Waist circumference measurement
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.
Measured: through study completion, an average of 1 year
Malnutrition Risk Score of participants
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.
Measured: through study completion, an average of 1 year
Body Fat Percentage
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.
Measured: through study completion, an average of 1 year
Forced Vital Capacity
Forced Vital Capacity will be measured via spirometry.
Measured: through study completion, an average of 1 year
Forced Expiratory Volume in 1 second
Forced Expiratory Volume in 1 second will be measured using spirometry.
Measured: through study completion, an average of 1 year
Forced Expiratory Volume in 1 second Forced Vital Capacity Ratio
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.
Measured: through study completion, an average of 1 year
Peak Expiratory Flow
This value will be measured using spirometry.
Measured: through study completion, an average of 1 year
Forced Expiratory Flow at 25-75%
This value will be measured using spirometry.
Measured: through study completion, an average of 1 year
Hip circumference measurement
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.
Measured: through study completion, an average of 1 year
upper middle arm circumference measurement
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.
Measured: through study completion, an average of 1 year
Triceps skinfold thickness
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start16 Jun 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Ciliary Dyskinesia (PCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Bargi, Izmir Democracy University
- Investigators
- Gülşah Barğı, Assoc Prof, Study director, Izmir Democracy UniversityAybüke S Demir, PT, MSc, Principal investigator, Izmir Democracy UniversityKerim K Göküstün, Asst Prof, Principal investigator, Izmir Democracy UniversityEce Ocak, Dr, Principal investigator, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740551
- Sponsor's protocol ID
- Sarcopenia in PCD
- Status last verified
- Nov 2026
- First submitted
- 23 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29269581Denizoglu 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.
PubMed 32877003Firat 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.
PubMed 34952415
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nutritional Status and Sarcopenia Between Children and Adolescents With Primary Ciliary Dyskinesia and Healthy Children
- ClinicalTrials.gov ID
- NCT07740551
- Acronym / sponsor ID
- Sarcopenia in PCD
- Conditions
- Primary Ciliary Dyskinesia (PCD)
- Keywords
- primary ciliary dyskinesia (PCD), sarcopenia, respiratory function test, malnutrion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Ciliary Dyskinesia Group | – | Other: Physical Evaluations in Children with Primary Ciliary DyskinesiaThis group will consist of children and adolescents with primary ciliary dyskinesia group. |
| Control Group | – | Other: Physical Evaluations in Healthy ChildrenThis group will consist of healthy children and adolescents. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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
- Having any orthopedic, neurological, psychological or cardiovascular problem that may prevent the measurements from being performed in the last 6 months
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Evaluations in Children with Primary Ciliary DyskinesiaIn 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. | Other | Primary Ciliary Dyskinesia Group |
| Physical Evaluations in Healthy ChildrenIn 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. | Other | Control Group |
Primary outcome
Hand Grip Strength
Time frame: 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.
13 secondary outcomes
Vertical Jump Power
Time frame: through study completion, an average of 1 year
Core muscle strength
Time frame: through study completion, an average of 1 year
Waist circumference measurement
Time frame: through study completion, an average of 1 year
Malnutrition Risk Score of participants
Time frame: through study completion, an average of 1 year
Body Fat Percentage
Time frame: through study completion, an average of 1 year
Forced Vital Capacity
Time frame: through study completion, an average of 1 year
Forced Expiratory Volume in 1 second
Time frame: through study completion, an average of 1 year
Forced Expiratory Volume in 1 second Forced Vital Capacity Ratio
Time frame: through study completion, an average of 1 year
Peak Expiratory Flow
Time frame: through study completion, an average of 1 year
Forced Expiratory Flow at 25-75%
Time frame: through study completion, an average of 1 year
Hip circumference measurement
Time frame: through study completion, an average of 1 year
upper middle arm circumference measurement
Time frame: through study completion, an average of 1 year
Triceps skinfold thickness
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- BackgroundBaptista, 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: PubMed 29269581Goutaki 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.
- Background: PubMed 32877003Denizoglu 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.
- Background: PubMed 34952415Firat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gülşah Barğı, Assoc Prof study director
Izmir Democracy University
Aybüke S Demir, PT, MSc principal investigator
Izmir Democracy University
Kerim K Göküstün, Asst Prof principal investigator
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Ciliary Dyskinesia (PCD), run by Izmir Democracy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gülşah Barğı, Assoc Prof (+90 232 299 0739, gulsahbargi35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Grip Strength (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07740551, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.