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
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2026
CompletedFirst Submitted
Initial submission to the registry
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
July 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
July 28, 2026
July 1, 2026
6 months
July 21, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Cystic Fibrosis Questionnaire-Revised (CFQ-R) Total Score
Baseline (Week 0) and post-intervention (Week 6).
Study Arms (2)
Autogenic Drainage Group
EXPERIMENTALParticipants 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.
Mechanical Percussion Group
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- History of thoracic surgery.
- Active hemoptysis.
- Severe physical or cognitive disabilities limiting participation in the intervention or assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nishter Hospital Multan
Multan Khurd, Punjab Province, 59300, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Humera Ayub, MS-CPPT
Riphah International University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2026
First Posted
July 28, 2026
Study Start
June 14, 2026
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
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.