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Идёт набор NCT06984679

Physical Impairments in Children With Cystic Fibrosis

— Наблюдательное Cystic Fibrosis (CF) Cystic Fibrosis in Children

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Physical Evaluations in Children with Cystic Fibrosis, Physical Evaluations in Healthy Children.
Кому может быть актуально
Состояния в реестре: Cystic Fibrosis (CF), Cystic Fibrosis in Children. Базовые параметры: 6 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Comparison of Dyspnea, Functional Capacity, Muscle Strength, Urinary Incontinence and Quality of Life Between Children and Adolescents With Cystic Fibrosis and Healthy Children

Обзор

It is aimed to reveal impairments regarding urinary incontinence, dyspnea, muscle strength, functional capacity or quality of life in children and adolescents with cystic fibrosis compared to healthy children and adolescents.

Подробное описание

This study aims to compare dyspnea, functional capacity, muscle strength, urinary incontinence and quality of life between children and adolescents with cystic fibrosis and healthy children and adolescents. Participants will be assessed for these parameters through clinical evaluations, exercise tests, questionnaires and measurements. The study aims to understand the health implications of cystic fibrosis and provide the basis for improvements in the health management of these individuals.

Вмешательства

  • Другое Physical Evaluations in Children with Cystic Fibrosis
    In this study, dyspnea, functional capacity, muscle strength, urinary incontinence and quality of life will be evaluated in children and adolescents with cystic fibrosis. The data to be obtained through all these evaluations will be done face to face within 45-60 minutes.
  • Другое Physical Evaluations in Healthy Children
    In this study, dyspnea, functional capacity, muscle strength, urinary incontinence and quality of life will be evaluated in healthy children and adolescents. The data to be obtained from all these assessments will be made face to face within 45-60 minutes.

Первичные конечные точки

  • Hand Grip Strength [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (8)
  • Dyspnea score [Срок оценки: through study completion, an average of 1 year]
  • Pulmonary Function Test Evaluation [Срок оценки: through study completion, an average of 1 year]
  • Respiratory Muscle Strength Evaluation [Срок оценки: through study completion, an average of 1 year]
  • Cough Strength Evaluation [Срок оценки: through study completion, an average of 1 year]
  • Aerobic Exercise Capacity Evaluation [Срок оценки: through study completion, an average of 1 year]
  • Anaerobic Exercise Capacity Evaluation [Срок оценки: through study completion, an average of 1 year]
  • Quality of Life Score [Срок оценки: through study completion, an average of 1 year]
  • Urinary incontinence score [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Inclusion Criteria for Children and Adolescents with Cystic Fibrosis:

  • To be between the ages of 6-18
  • To have been diagnosed with cystic fibrosis
  • 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 cystic fibrosis 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 Cystic Fibrosis:

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр
  • Izmir Democracy University — Izmir

Публикации

  • Tuğay, B. U., Arıkan, H., & Özçelik, U. (2004). Kistik fibrozisli çocuklarda pulmoner fonksiyonlar ve vücut kompozisyonu ile kas kuvveti arasındaki ilişki. Fizyoterapi ve Rehabilitasyon, 15(2), 47-54.
  • Frayman KB, Kazmerski TM, Sawyer SM. A systematic review of the prevalence and impact of urinary incontinence in cystic fibrosis. Respirology. 2018 Jan;23(1):46-54. doi: 10.1111/resp.13125. Epub 2017 Jul 18. PMID 28718995
  • Heron J, Grzeda MT, von Gontard A, Wright A, Joinson C. Trajectories of urinary incontinence in childhood and bladder and bowel symptoms in adolescence: prospective cohort study. BMJ Open. 2017 Mar 14;7(3):e014238. doi: 10.1136/bmjopen-2016-014238. PMID 28292756

Идентификаторы

NCT: NCT06984679 · Healthy and Cystic Fibrosis

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗