Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorIzmir Democracy University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Physical Evaluations in Children with Primary Ciliary Dyskinesia

    Other intervention

    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 intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Primary Ciliary Dyskinesia Group1 intervention
Group B: Control Group1 intervention

Trial outcomes

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.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

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.

Time frame
through study completion, an average of 1 year
2

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).

Time frame
through study completion, an average of 1 year
3

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.

Time frame
through study completion, an average of 1 year
4

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.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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