NCT07729787

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress29%
Jun 2026Nov 2026

Study Start

First participant enrolled

June 14, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 21, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

Cystic FibrosisAutogenic DrainageMechanical PercussionAirway Clearance TechniquesChest PhysiotherapyPulmonary FunctionSpirometryDyspnea

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

EXPERIMENTAL

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

Mechanical Percussion Group

EXPERIMENTAL

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

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.

Also known as: Airway Clearance Technique AD
Autogenic Drainage Group

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.

Also known as: Mechanical Chest Percussion Chest Percussion Therapy High-Frequency Percussion Therapy
Mechanical Percussion Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

RECRUITING

MeSH Terms

Conditions

Cystic FibrosisDyspnea

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Humera Ayub, MS-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

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
Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups: Autogenic Drainage (AD) or Mechanical Percussion (MP). Each group will receive its assigned intervention five times per week for six weeks. Outcomes including lung function (FEV₁ and FVC), dyspnea, and quality of life will be assessed at baseline and after completion of the intervention period. Participants will remain in their assigned group throughout the study, and no crossover between interventions will occur.
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.

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