Comparative Effects of Autogenic Drainage and Mechanical Percussion on Lung Function, Dyspnea and Quality of Life in Children With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in One Second (FEV₁)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study uses a single-blind design in which outcome assessors are blinded to participant group allocation. Outcome assessments, including spirometry, dyspnea evaluation, and quality-of-life measurements, are performed by assessors who are not involved in treatment delivery. Participants and treating physiotherapists are not blinded because of the nature of the interventions.
入排标准
- 年龄范围
- 6 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •History of thoracic surgery.
- •Active hemoptysis.
- •Severe physical or cognitive disabilities limiting participation in the intervention or assessments.
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV₁)
时间窗: Baseline (Week 0) and post-intervention (Week 6).
Change in Forced Expiratory Volume in one second (FEV₁) measured using spirometry and reported in liters (L). Higher values indicate improved pulmonary function.
Forced Vital Capacity (FVC)
时间窗: Baseline (Week 0) and post-intervention (Week 6).
Change in Forced Vital Capacity (FVC) measured using spirometry and reported in liters (L). Higher values indicate improved pulmonary function.
Dyspnea
时间窗: Baseline (Week 0) and post-intervention (Week 6).
Change in dyspnea severity measured using the Modified Borg Dyspnea Scale (0-10). Lower scores indicate reduced dyspnea and clinical improvement.
次要结局
- Cystic Fibrosis Questionnaire-Revised (CFQ-R) Total Score(Baseline (Week 0) and post-intervention (Week 6).)
