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NCT Number: NCT07740551

Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls

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.

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Key information

Conditions

Primary Ciliary Dyskinesia (PCD) Abnormalities, Multiple Atrophy Ciliary Motility Disorders Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sarcopenia Signs and Symptoms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. Forced Vital Capacity

    Time frame: through study completion, an average of 1 year

    Forced Vital Capacity will be measured via spirometry.

  7. 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.

  8. 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.

  9. Peak Expiratory Flow

    Time frame: through study completion, an average of 1 year

    This value will be measured using spirometry.

  10. Forced Expiratory Flow at 25-75%

    Time frame: through study completion, an average of 1 year

    This value will be measured using spirometry.

  11. 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.

  12. 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.

  13. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aybüke S Demir, PT, MSc

CONTACT

[email protected]

+90 543 215 0018

Gülşah Barğı, Assoc Prof

CONTACT

[email protected]

+90 232 299 0739

Sponsors and collaborators

Lead sponsor

Izmir Democracy University

Other

Registry information

Official study title

Comparison of Nutritional Status and Sarcopenia Between Children and Adolescents With Primary Ciliary Dyskinesia and Healthy Children

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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