Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
2026년 7월 28일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
관찰
등록 (추정된)
30
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Gülşah Barğı, Assoc Prof
- 전화번호: +90 232 299 0739
- 이메일: gulsahbargi35@gmail.com
연구 연락처 백업
- 이름: Aybüke S Demir, PT, MSc
- 전화번호: +90 543 215 0018
- 이메일: aybukedemir1108@gmail.com
연구 장소
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Izmir, 터키 (Türkiye), 35140
- Izmir Democracy University
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연락하다:
- Gülşah Barğı, Assoc Prof
- 전화번호: +905317938766
- 이메일: gulsah.bargi@idu.edu.tr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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제어 그룹
이 그룹은 건강한 어린이와 청소년으로 구성됩니다.
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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.
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Primary Ciliary Dyskinesia Group
This group will consist of children and adolescents with primary ciliary dyskinesia group.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Hand Grip Strength
기간: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vertical Jump Power
기간: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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Core muscle strength
기간: through study completion, an average of 1 year
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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).
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through study completion, an average of 1 year
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Waist circumference measurement
기간: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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Malnutrition Risk Score of participants
기간: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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Body Fat Percentage
기간: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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Forced Vital Capacity
기간: through study completion, an average of 1 year
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Forced Vital Capacity will be measured via spirometry.
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through study completion, an average of 1 year
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Forced Expiratory Volume in 1 second
기간: through study completion, an average of 1 year
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Forced Expiratory Volume in 1 second will be measured using spirometry.
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through study completion, an average of 1 year
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Forced Expiratory Volume in 1 second Forced Vital Capacity Ratio
기간: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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Peak Expiratory Flow
기간: through study completion, an average of 1 year
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This value will be measured using spirometry.
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through study completion, an average of 1 year
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Forced Expiratory Flow at 25-75%
기간: through study completion, an average of 1 year
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This value will be measured using spirometry.
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through study completion, an average of 1 year
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Hip circumference measurement
기간: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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upper middle arm circumference measurement
기간: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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Triceps skinfold thickness
기간: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Gülşah Barğı, Assoc Prof, Izmir Democracy University
- 수석 연구원: Ece Ocak, Dr, İzmir City Hospital
- 수석 연구원: Aybüke S Demir, PT, MSc, Izmir Democracy University
- 수석 연구원: Kerim K Göküstün, Asst Prof, Izmir Democracy University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2027년 8월 1일
연구 완료 (추정된)
2027년 8월 1일
연구 등록 날짜
최초 제출
2026년 7월 23일
QC 기준을 충족하는 최초 제출
2026년 7월 28일
처음 게시됨 (실제)
2026년 7월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 28일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Sarcopenia in PCD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .