Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls

July 28, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
This group will consist of healthy children and adolescents.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertical Jump Power
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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%
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Democracy University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

July 23, 2026

First Submitted That Met QC Criteria

July 28, 2026

First Posted (Actual)

July 31, 2026

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sarcopenia in PCD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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