Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis (EGmACT-CF)

May 5, 2025 updated by: Alvaro Alba Rueda, Universidad de Córdoba

Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis: A 24-Week Randomized Controlled Trial.

The aim of this randomized controlled trial is to evaluate the effectiveness of gamified mobile health (mHealth) applications for airway clearance therapy in children and adolescents with cystic fibrosis. Primary outcomes include Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV₁), adherence to therapy, health-related quality of life (HRQoL), and satisfaction with the intervention. The intervention will consist of 20-minute sessions, performed twice daily over a 24-week period. At least a total of 36 participants aged 8 to 18 years with cystic fibrosis will be randomly assigned to three equally sized groups: the experimental group (gamified mHealth apps: Voice Volume Catcher, Scream Go Hero, and Chicken Scream), the control group (conventional airway clearance techniques: Autogenic Drainage, Active Cycle of Breathing Techniques, and Positive Expiratory Pressure therapy), and the mixed group (10 minutes of gamified mHealth apps combined with 10 minutes of conventional techniques). This study seeks to provide evidence on the feasibility and clinical benefits of integrating gamification into airway clearance therapy to improve respiratory outcomes and patient engagement in pediatric cystic fibrosis care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41013
        • Asociación Andaluza de Fibrosis Quística
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

  • Inclusion Criteria:

    • Population with cystic fibrosis (CF), aged 8-20 years.
    • Individuals using or not using CFTR modulators (e.g., Kaftrio, Kalydeco, etc.), regardless of their specific mutation.

  • Exclusion Criteria:

    • Forced Vital Capacity (FVC) and/or Forced Expiratory Volume in the first second (FEV1) < 40%.
    • Oxygen therapy or continuous mechanical ventilation.
    • Moderate hemoptysis or recent pneumothorax (within the past 3 months).
    • Presence of an active, uncontrolled respiratory infection exacerbation that required hospitalization within the 30 days prior to the intervention.
    • Other conditions such as neuromuscular disorders or cognitive difficulties (Mini-Mental State Examination score < 19 points).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
At least twelve participants will engage in airway clearance therapy using gamified mobile health (mHealth) applications. These apps are designed to promote the control of sound intensity during open-glottis expiratory maneuvers, utilizing the smartphone's integrated microphone to detect vocal output. The sound generated during breathing reflects active respiratory effort and effective glottic control, supporting secretion mobilization and enhancing airway clearance efficacy.
Other: Gamified mobile health applications
  • Voice Volume Catcher: A game where players control a character's movement by modulating their voice volume. Louder or softer sounds move a basket to collect different types of fruits, encouraging continuous vocal engagement and fine control of breath intensity.
  • Scream Go Hero: A voice-controlled platform game where players produce short or long vocalizations to make the hero character jump or move across obstacles. The game demands breath control and supports prolonged exhalations for larger jumps with an open glottis, which is beneficial for airway clearance.
  • Chicken Scream: A voice-activated game where players guide a chicken character by varying their vocal intensity to make it walk, jump, and avoid enemies. Participants must dynamically adjust their breath pressure and vocal intensity while maintaining open-glottis breathing, promoting agility in respiratory control.
Other Names:
  • Gamified mHealth Apps
Active Comparator: Control Group
At least twelve participants will undergo treatment with conventional airway clearance techniques. These techniques are designed to promote effective secretion mobilization and improve lung function. Participants will be guided through a series of controlled breathing exercises aimed at optimizing airflow and enhancing secretion clearance. These methods involve active participation to perform specific maneuvers that facilitate the removal of mucus from the airways, improving overall respiratory function.
Other: Conventional Airway Clearance Therapy
  • Autogenic Drainage: A technique where participants perform a series of controlled breathing cycles-deep inhalations followed by forceful exhalations-to mobilize mucus from the lower airways to the upper airways. The technique encourages breath control and helps clear secretions without the need for coughing, promoting efficient airway clearance.
  • Active Cycle of Breathing Techniques (ACBT): In this technique, participants alternate between relaxed breathing, deep breaths, and huffing to mobilize and expel mucus from the lungs. It focuses on breathing control to loosen and expel secretions effectively while maintaining a steady airflow throughout the process.
  • Positive Expiratory Pressure (PEP) Therapy: This technique involves exhaling against a resistance through a device, which helps to open the airways and prevent their collapse. The resistance promotes prolonged exhalations, facilitating the movement of mucus from the small airways to the larger airways for easier clearance.
Active Comparator: Mixed Intervention Group
At least twelve participants will undergo a combined intervention, consisting of 10 minutes of gamified mHealth app use followed by 10 minutes of conventional airway clearance techniques, or the sequence may be reversed. This dual approach will enable participants to benefit from both interactive digital engagement and established respiratory therapies, optimizing mucus clearance and enhancing overall pulmonary function.
Other: Combination Treatment

- Gamified mHealth Apps (10 minutes):

Voice Volume Catcher

Scream Go Hero

Chicken Scream

- Conventional Airway Clearance Techniques (10 minutes):

Autogenic Drainage

Active Cycle of Breathing Techniques (ACBT)

Positive Expiratory Pressure (PEP) Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC)
Time Frame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Total volume of air that can be forcibly exhaled after a full inhalation. It is a key parameter measured during spirometry testing to assess lung function.
This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Forced Expiratory Volume in the first second (FEV₁)
Time Frame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
The volume of air exhaled during the first second of a forced exhalation after a full inhalation. It is a key parameter measured during spirometry testing to assess airflow and diagnose respiratory conditions.
This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Adherence to therapy
Time Frame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
The extent to which participants follow the prescribed therapeutic regimen. Adherence will be assessed over time using the gamified mHealth app (experimental group), a stopwatch application (control group), or a combination of both (mixed intervention group), all monitored through the StayFree app.
This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Health-related quality of life (HRQoL)
Time Frame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
This measure will evaluate the impact of cystic fibrosis on participants' daily lives, including physical, emotional, and social well-being. The age-adapted Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be used. The CFQ-R scores range from 0 to 100, with higher scores indicating better health-related quality of life. Cut-off points may vary depending on the study's context, but scores below 50 are often interpreted as indicating significant impairment in quality of life.
This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Satisfaction with the intervention
Time Frame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
The outcome will be assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM), adapted for a physical therapy intervention. This tool will measure participants' contentment with the therapy and their overall treatment experience. The TSQM scores range from 0 to 100 for each domain (effectiveness, side effects, convenience, and global satisfaction), with higher scores indicating greater satisfaction. There are no universally established cut-off points, but higher scores typically reflect more positive treatment experiences.
This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Córdoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAFQFISIO2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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