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Идёт набор NCT07729787

Autogenic Drainage Versus Mechanical Percussion in Children With Cystic Fibrosis

Без фазы С лечением Cystic Fibrosis (CF)

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: Autogenic Drainage, Mechanical Percussion.
Кому может быть актуально
Состояния в реестре: Cystic Fibrosis (CF). Базовые параметры: 6 лет — 12 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparative Effects of Autogenic Drainage and Mechanical Percussion on Lung Function, Dyspnea and Quality of Life in Children With Cystic Fibrosis

Обзор

The goal of this clinical trial is to compare the effects of autogenic drainage and mechanical percussion on lung function, dyspnea, and quality of life in children with cystic fibrosis. The main questions it aims to answer are: * Does autogenic drainage improve lung function more effectively than mechanical percussion in children with cystic fibrosis? * Does autogenic drainage reduce dyspnea (breathlessness) more effectively than mechanical percussion? * Does autogenic drainage improve health-related quality of life more effectively than mechanical percussion? Researchers will compare autogenic drainage with mechanical percussion to determine which airway clearance technique provides greater benefits for children with cystic fibrosis. Participants will: * Be randomly assigned to receive either autogenic drainage or mechanical percussion therapy. * Participate in supervised treatment sessions five times per week for six weeks. * Undergo assessments of lung function using spirometry (FEV₁ and FVC), dyspnea using the Modified Borg Dyspnea Scale, and quality of life using the Cystic Fibrosis Questionnaire-Revised (CFQ-R) before and after the intervention period. The findings of this study may help identify the most effective airway clearance technique for improving respiratory health and quality of life in children with cystic fibrosis.

Подробное описание

Cystic fibrosis (CF) is a life-limiting autosomal recessive genetic disorder caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Dysfunction of the CFTR protein leads to impaired chloride and water transport across epithelial surfaces, resulting in the production of thick, dehydrated secretions in multiple organ systems, particularly the respiratory tract. The accumulation of viscous mucus within the airways contributes to chronic airway obstruction, recurrent pulmonary infections, persistent inflammation, progressive lung damage, and declining respiratory function. Despite advances in pharmacological treatment and supportive care, pulmonary complications remain the leading cause of morbidity and mortality in individuals with cystic fibrosis.

Airway clearance therapy is a fundamental component of respiratory management in patients with CF. The primary objective of airway clearance techniques (ACTs) is to mobilize and remove retained airway secretions, thereby improving ventilation, reducing airway obstruction, minimizing infection risk, preserving lung function, and enhancing quality of life. Various ACTs are available and are routinely incorporated into multidisciplinary CF care programs. However, determining the most effective airway clearance strategy remains challenging because patient responses vary and comparative evidence among techniques is often limited.

Autogenic drainage (AD) is an airway clearance technique based on controlled breathing at different lung volumes. The technique consists of three phases: unsticking, collecting, and evacuating secretions. Through carefully regulated inspiratory and expiratory airflow, AD promotes mucus mobilization from peripheral airways toward central airways where it can be effectively expectorated. Because the technique relies on self-regulated breathing rather than external mechanical forces, it may improve patient comfort, encourage independence, and facilitate long-term adherence. Previous studies have suggested that AD may improve pulmonary function, reduce airway resistance, enhance mucus clearance, and improve patient satisfaction. Nevertheless, evidence in pediatric populations remains limited.

Mechanical percussion is another commonly utilized airway clearance intervention in cystic fibrosis management. This technique employs rhythmic mechanical vibrations or percussion applied externally to the thoracic cage to loosen mucus adhered to airway walls. Mechanical percussion aims to facilitate mucus mobilization and subsequent clearance from the respiratory tract. The technique is frequently used in pediatric respiratory rehabilitation because it requires minimal active participation from younger children and can be administered by healthcare professionals or caregivers. Several studies have reported beneficial effects of mechanical percussion on secretion clearance and respiratory status. However, concerns regarding comfort, treatment burden, and long-term adherence have led clinicians to explore alternative airway clearance approaches.

Although both autogenic drainage and mechanical percussion are widely used in clinical practice, direct comparisons between these interventions in children with cystic fibrosis are scarce. Existing studies often include mixed age groups, employ heterogeneous outcome measures, or focus primarily on short-term physiological responses. Furthermore, limited evidence is available regarding their comparative effects on patient-centered outcomes such as dyspnea and health-related quality of life. Consequently, there remains uncertainty regarding which intervention provides superior clinical benefits for pediatric patients with CF.

The present study is designed to address this gap in the literature by directly comparing autogenic drainage and mechanical percussion in children diagnosed with cystic fibrosis. The study will employ a randomized clinical trial design to evaluate the relative effectiveness of these interventions on respiratory function, symptom burden, and quality of life. Participants meeting eligibility criteria will be recruited from tertiary care healthcare facilities and randomly allocated to one of two intervention groups.

Participants assigned to the Autogenic Drainage Group will receive therapist-guided autogenic drainage sessions. The intervention will be delivered according to standardized clinical procedures and will emphasize controlled breathing patterns designed to mobilize secretions from distal to proximal airways. Participants will receive training and supervision from qualified physiotherapists to ensure proper technique execution and treatment consistency.

Participants assigned to the Mechanical Percussion Group will receive standardized mechanical chest percussion therapy using a mechanical percussion device. Treatment protocols will follow established clinical recommendations to ensure consistent delivery and participant safety. Sessions will be administered by trained physiotherapists using appropriate positioning and device settings tailored to individual patient tolerance.

Both intervention groups will receive treatment five days per week for six consecutive weeks. Each treatment session will last approximately ten minutes and will be delivered under professional supervision to maximize adherence and ensure protocol fidelity. The frequency and duration of treatment were selected based on previous research demonstrating clinically meaningful improvements in respiratory outcomes among pediatric respiratory populations.

The primary outcomes of interest will include pulmonary function parameters measured using spirometry. Forced Expiratory Volume in One Second (FEV₁) and Forced Vital Capacity (FVC) will be assessed as objective indicators of respiratory function and airway clearance effectiveness. Spirometry remains the gold-standard method for evaluating pulmonary status in individuals with cystic fibrosis and provides clinically relevant information regarding disease progression and treatment response.

Secondary outcomes will include dyspnea and health-related quality of life. Dyspnea will be evaluated using the Modified Borg Dyspnea Scale, a validated subjective measure commonly used to assess perceived breathlessness in respiratory populations. Health-related quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a disease-specific instrument that evaluates the impact of cystic fibrosis on physical, emotional, and social functioning.

Outcome assessments will be conducted at baseline before intervention initiation and repeated following completion of the six-week treatment program. Statistical analyses will compare changes within each intervention group and between groups to determine whether one airway clearance technique demonstrates superior effectiveness.

The findings of this study are expected to contribute important evidence regarding airway clearance management in pediatric cystic fibrosis. By directly comparing autogenic drainage and mechanical percussion using objective and patient-reported outcome measures, the study may help clinicians make informed treatment decisions and optimize respiratory rehabilitation strategies. Improved understanding of the relative benefits of these interventions may ultimately enhance pulmonary health, reduce symptom burden, promote treatment adherence, and improve quality of life for children living with cystic fibrosis.

Вмешательства

  • Процедура Autogenic Drainage
    Autogenic drainage is a breathing-based airway clearance technique designed to mobilize and remove bronchial secretions. Participants will receive therapist-guided autogenic drainage sessions consisting of controlled breathing at low, medium, and high lung volumes to facilitate mucus movement from peripheral to central airways. Treatment sessions will be conducted under physiotherapist supervision for approximately 10 minutes per session, five times per week, for six weeks.
  • Устройство Mechanical Percussion
    Mechanical percussion is an airway clearance intervention that utilizes a mechanical percussion device to generate rhythmic vibrations over the chest wall to loosen and mobilize pulmonary secretions. Participants will receive supervised mechanical percussion therapy for approximately 10 minutes per session, five times per week, for six weeks. Treatment will be delivered according to standardized clinical procedures, with device settings adjusted to participant tolerance and clinical response.

Первичные конечные точки

  • Forced Expiratory Volume in One Second (FEV₁) [Срок оценки: Baseline (Week 0) and post-intervention (Week 6).]
  • Forced Vital Capacity (FVC) [Срок оценки: Baseline (Week 0) and post-intervention (Week 6).]
  • Dyspnea [Срок оценки: Baseline (Week 0) and post-intervention (Week 6).]
Вторичные конечные точки (1)
  • Cystic Fibrosis Questionnaire-Revised (CFQ-R) Total Score [Срок оценки: Baseline (Week 0) and post-intervention (Week 6).]

Критерии участия

Критерии включения

  • Confirmed diagnosis of cystic fibrosis (CF) through a sweat test or genetic testing.
  • Age between 6 and 12 years.
  • Clinically stable condition (no acute pulmonary exacerbation within the last 4 weeks).

Критерии исключения

  • History of thoracic surgery.
  • Active hemoptysis.
  • Severe physical or cognitive disabilities limiting participation in the intervention or assessments.

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
  • Nishter Hospital Multan — Multan Khurd

Идентификаторы

NCT: NCT07729787 · REC/RCR & AHS/25/0318

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗