Autogenic Drainage Versus Mechanical Percussion in Children With Cystic Fibrosis (ADMP-CF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis (CF)
• Intervention / Treatment: Procedure: Autogenic Drainage; Device: Mechanical Percussion

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, PhD; Phone Number: 03324390125; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Multan Khurd, Punjab Province, Pakistan, 59300
      • Recruiting
      • Nishter Hospital Multan
      • Contact: Humera Ayub, MS CPPT; Phone Number: +923045938096; Email: humera.ayub@riphah.edu.pk
      • Sub-Investigator: Muhammad Farhan Faiz, MS-CPPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autogenic Drainage Group; Participants assigned to this arm will receive therapist-guided autogenic drainage, an airway clearance technique that uses controlled breathing at different lung volumes to mobilize secretions from peripheral to central airways. Treatment sessions will be administered five times per week for six weeks, with each session lasting approximately 10 minutes under physiotherapist supervision.	Procedure: 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.; Other Names: Airway Clearance Technique AD
Experimental: Mechanical Percussion Group; Participants assigned to this arm will receive mechanical chest percussion therapy using a high-frequency percussion device to facilitate airway secretion clearance. Treatment sessions will be administered five times per week for six weeks, with each session lasting approximately 10 minutes under physiotherapist supervision.	Device: 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.; Other Names: Mechanical Chest Percussion Chest Percussion Therapy High-Frequency Percussion Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Week 0) and post-intervention (Week 6).
Forced Vital Capacity (FVC)	Change in Forced Vital Capacity (FVC) measured using spirometry and reported in liters (L). Higher values indicate improved pulmonary function.	Baseline (Week 0) and post-intervention (Week 6).
Dyspnea	Change in dyspnea severity measured using the Modified Borg Dyspnea Scale (0-10). Lower scores indicate reduced dyspnea and clinical improvement.	Baseline (Week 0) and post-intervention (Week 6).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Week 0) and post-intervention (Week 6).

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Humera Ayub, MS-CPPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 27, 2026
• First Posted (Actual): July 28, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Pulmonary Function; Dyspnea; Spirometry; Chest Physiotherapy; Airway Clearance Techniques; Autogenic Drainage; Mechanical Percussion
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Respiration Disorders; Infant, Newborn, Diseases; Pancreatic Diseases; Signs and Symptoms, Respiratory; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cystic Fibrosis; Dyspnea
• Other Study ID Numbers: REC/RCR & AHS/25/0318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data (IPD) will not be shared because the study involves a small sample of pediatric participants with cystic fibrosis, and sharing de-identified data may still pose a risk of participant re-identification. Furthermore, the informed consent obtained from participants and their guardians did not include provisions for public sharing of individual-level data. Only aggregate study results will be reported to protect participant confidentiality and privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No