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Набор скоро начнётся NCT07062939

Comparative Effects of Mechanical and Manual Airway Clearance Techniques in Cystic Fibrosis

Без фазы С лечением Cystic Fibrosis

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: postural drainage with ACBT, flutter with ACBT.
Кому может быть актуально
Состояния в реестре: Cystic Fibrosis. Базовые параметры: 16 лет — 40 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
Пакистан
Следующий шаг
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Официальное название

Comparative Effects of Manual Versus Mechanical Airway Clearance Techniques in Cystic Fibrosis

Обзор

This study will help to establish evidence-based physiotherapy on postural drainage and ACBT against flutter with ACBT is better to improve sleep quality, adherence, dyspnea in patients with cystic fibrosis and which method can improve respiratory function, reduce the risk of complications after illness and additionally advancements in respiratory therapy can lead to improve sleep quality, individual preference and adherence and dyspnea.

Подробное описание

Cystic fibrosis (CF) is a genetic disorder that leads to the accumulation of thick mucus in the lungs and other organs, resulting in recurrent infections and progressive lung damage. This condition is due to mutations in the cystic fibrosis transmembrane conductance regulator CFTR gene, which governs the transport of chloride and other ions across cell membranes. CF affects a significant number of people worldwide, with certain genetic mutations leading to more severe manifestations of the disease. The management of CF is centered on clearing the airways of mucus to prevent infections and slow the progression of lung damage. Various studies have yielded inconsistent results regarding the comparative effectiveness of manual versus mechanical airway clearance techniques in improving pulmonary function tests (PFTs) in CF patients.

Despite the existing literature on postural drainage with ACBT in patient with cystic fibrosis, there is a significant research gap regarding the flutter and ACBT on the bases of outcomes in cystic fibrosis. Most studies have not adequately addressed the distinct needs and responses of flutter with ACBT on the basis of outcomes, leaving a void in understanding how these two intervention effect on sleep, adherence and dyspnea in the context of patients with cystic fibrosis. Closing this gap is essential for developing evidence-based and pulmonary rehabilitation techniques for this specific patient group.

Вмешательства

  • Другое postural drainage with ACBT
    postural drainage and ACBT for 2 times a day for 30 min for 4 weeks.
  • Другое flutter with ACBT
    flutter with active cycle breathing technique for 30 min. for 4 week and 2 times a day.

Первичные конечные точки

  • The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 4 weeks]
  • The Shwachman-Kulczycki score [Срок оценки: 4 weeks]
  • Borg dyspnea scale [Срок оценки: 4 weeks]
Вторичные конечные точки (1)
  • The Breathlessness, Cough and Sputum Scale (BCSS) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

  • Patient having clinically diagnose Cystic fibrosis.
  • Age 16-40 year.
  • Both male and female.
  • Subjects who are conscious and cooperative .

Критерии исключения

  • Rib fracture
  • History of cardiac surgery.
  • Subject with any Physical or Mental Disability
  • Age less than 16 years

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • DHQ Hospital — Sheikhupura

Публикации

  • Zisi D, Chryssanthopoulos C, Nanas S, Philippou A. The effectiveness of the active cycle of breathing technique in patients with chronic respiratory diseases: A systematic review. Heart Lung. 2022 May-Jun;53:89-98. doi: 10.1016/j.hrtlng.2022.02.006. Epub 2022 Feb 27. PMID 35235877
  • Chen Q, Shen Y, Zheng J. A review of cystic fibrosis: Basic and clinical aspects. Animal Model Exp Med. 2021 Sep 16;4(3):220-232. doi: 10.1002/ame2.12180. eCollection 2021 Sep. PMID 34557648
  • Elborn JS, Ramsey BW, Boyle MP, Konstan MW, Huang X, Marigowda G, Waltz D, Wainwright CE; VX-809 TRAFFIC and TRANSPORT study groups. Efficacy and safety of lumacaftor/ivacaftor combination therapy in patients with cystic fibrosis homozygous for Phe508del CFTR by pulmonary function subgroup: a pooled analysis. Lancet Respir Med. 2016 Aug;4(8):617-626. doi: 10.1016/S2213-2600(16)30121-7. Epub 2016 J PMID 27298017
  • Wilson LM, Saldanha IJ, Robinson KA. Active cycle of breathing technique for cystic fibrosis. Cochrane Database Syst Rev. 2023 Feb 2;2(2):CD007862. doi: 10.1002/14651858.CD007862.pub5. PMID 36727723
  • Rowbotham NJ, Smith SJ, Davies G, Daniels T, Elliott ZC, Gathercole K, Rayner OC, Smyth AR. Can exercise replace airway clearance techniques in cystic fibrosis? A survey of patients and healthcare professionals. J Cyst Fibros. 2020 Jul;19(4):e19-e24. doi: 10.1016/j.jcf.2019.10.026. Epub 2019 Nov 15. PMID 31740105
  • Zhao M, Cheng L, Fu W, Ma X, Chen X. Measuring parents' perceptions of inclusive school quality in China: the development of the PISQ scale. Int J Dev Disabil. 2021 Mar 10;68(6):824-837. doi: 10.1080/20473869.2021.1895696. eCollection 2022. PMID 36568612

Идентификаторы

NCT: NCT07062939 · REC/RCR & AHS/24/0350

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗