Cystic Fibrosis (CF)EGmACT-CFNCT06958094
Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis
A study testing Gamified mobile health applications, Conventional Airway Clearance Therapy and Combination Treatment in people with Cystic Fibrosis (CF), run by Universidad de Córdoba at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- Gamified mobile health applications, Conventional Airway Clearance Therapy and Combination Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to 1 Jan 2027
- 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 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Asociación Andaluza de Fibrosis Quística
Seville, Seville, 41013
Prof. Alvaro Alba Rueda, Master. Current PhD student, +34 744723150, alvaro.alba@fqandalucia.org
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- Gamified mobile health applications, Conventional Airway Clearance Therapy, Combination Treatment
- Keywords
- MHealth, Gamification, Mobile App, Adherence, Engagement, Motivation, Children, Adolescent, Randomized Controlled Trial
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified mobile health applicationsOther
Also called Gamified mHealth Apps
- 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.
Conventional Airway Clearance TherapyOther
- 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.
Combination TreatmentOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Other: Gamified mobile health applications |
| Control Group | Active comparator | 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. Receives: Other: Conventional Airway Clearance Therapy |
| Mixed Intervention Group | Active comparator | 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. Receives: Other: Combination Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
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.
Measured: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Forced Expiratory Volume in the first second (FEV₁)
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.
Measured: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Adherence to therapy
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.
Measured: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Health-related quality of life (HRQoL)
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.
Measured: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Satisfaction with the intervention
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.
Measured: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Alba Rueda, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958094
- Sponsor's protocol ID
- AAFQFISIO2025
- Acronym
- EGmACT-CF
- Status last verified
- May 2025
- First submitted
- 27 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis: A 24-Week Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06958094
- Acronym / sponsor ID
- EGmACT-CF / AAFQFISIO2025
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- MHealth, Gamification, Mobile App, Adherence, Engagement, Motivation, Children, Adolescent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidad de CórdobaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Gamified mobile health applicationsAt 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. |
| Control Group | Active comparator | Other: Conventional Airway Clearance TherapyAt 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. |
| Mixed Intervention Group | Active comparator | Other: Combination TreatmentAt 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. |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified mobile health applicationsAlso: Gamified mHealth Apps* 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 | Experimental Group |
| 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. | Other | Control Group |
| 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 | Other | Mixed Intervention Group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified mobile health applications, Conventional Airway Clearance Therapy and Combination Treatment in people with Cystic Fibrosis (CF), run by Universidad de Córdoba at 1 site in Spain.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 May 2025. 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.). The study lists 5 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 8 May 2025.