About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
History of thoracic surgery.
Active hemoptysis.
Severe physical or cognitive disabilities limiting participation in the intervention or assessments.
Trial design
Parallel
Treatments tested in this trial
Autogenic Drainage
Procedure/SurgeryAutogenic 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.
Mechanical Percussion
DeviceMechanical 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.
Treatment groups
Trial outcomes
Primary outcomes
Forced Expiratory Volume in One Second (FEV₁)
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)
Change in Forced Vital Capacity (FVC) measured using spirometry and reported in liters (L). Higher values indicate improved pulmonary function.
Dyspnea
Change in dyspnea severity measured using the Modified Borg Dyspnea Scale (0-10). Lower scores indicate reduced dyspnea and clinical improvement.
Secondary outcomes
Cystic Fibrosis Questionnaire-Revised (CFQ-R) Total Score
Change in health-related quality of life measured using the Cystic Fibrosis Questionnaire-Revised (CFQ-R). Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Sponsors and contacts
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