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Cystic Fibrosis (CF)ADMP-CFNCT07729787

Autogenic Drainage Versus Mechanical Percussion in Children With Cystic Fibrosis

A study testing Autogenic Drainage and Mechanical Percussion in people with Cystic Fibrosis (CF), run by Riphah International University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Cystic Fibrosis (CF)
What is being tested?
Autogenic Drainage and Mechanical Percussion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
14 Jun 2026to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Imran Amjad, PhD contact

03324390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Nishter Hospital Multan

    Multan Khurd, Punjab Province, 59300

    Humera Ayub, MS CPPT, +923045938096, humera.ayub@riphah.edu.pk

    Muhammad Farhan Faiz, MS-CPPT

    Recruiting

Other trials in Pakistan

About this study

Official title: 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:

Read more
  • 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.

Read the 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.

Being tested
Autogenic Drainage, Mechanical Percussion
Keywords
Cystic Fibrosis, Autogenic Drainage, Mechanical Percussion, Airway Clearance Techniques, Chest Physiotherapy, Pulmonary Function, Spirometry, Dyspnea
Medical subject headings
Cystic Fibrosis, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autogenic DrainageProcedure or surgery

    Also called Airway Clearance Technique AD

    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 PercussionDevice

    Also called Mechanical Chest Percussion Chest Percussion Therapy High-Frequency Percussion Therapy

    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.

Study groups in NCT07729787
Study groupRoleWhat they receive
Autogenic Drainage GroupExperimentalParticipants 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.
Receives: Procedure: Autogenic Drainage
Mechanical Percussion GroupExperimentalParticipants 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.
Receives: Device: Mechanical Percussion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Week 0) and post-intervention (Week 6).

  2. Forced Vital Capacity (FVC)

    Change in Forced Vital Capacity (FVC) measured using spirometry and reported in liters (L). Higher values indicate improved pulmonary function.

    Measured: Baseline (Week 0) and post-intervention (Week 6).

  3. Dyspnea

    Change in dyspnea severity measured using the Modified Borg Dyspnea Scale (0-10). Lower scores indicate reduced dyspnea and clinical improvement.

    Measured: Baseline (Week 0) and post-intervention (Week 6).

Secondary outcomes (1)
  1. 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.

    Measured: Baseline (Week 0) and post-intervention (Week 6).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start14 Jun 2026
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07729787
Sponsor's protocol ID
REC/RCR & AHS/25/0318
Acronym
ADMP-CF
Status last verified
Jul 2026
First submitted
21 Jul 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Autogenic Drainage and Mechanical Percussion in people with Cystic Fibrosis (CF), run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Expiratory Volume in One Second (FEV₁) (time frame: Baseline (Week 0) and post-intervention (Week 6).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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