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

Universidad de Córdoba

Status: Begins enrollment in 7 months

Conditions: Cystic Fibrosis (CF)

Treatments: Other: Combination Treatment; Other: Conventional Airway Clearance Therapy; Other: Gamified mobile health applications

Study type: Interventional

Funder types: Other

Identifiers

NCT06958094

AAFQFISIO2025

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 8 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Experimental Group

Experimental group

Description:

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.

Treatment:

Other: Gamified mobile health applications

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Airway Clearance Therapy

Mixed Intervention Group

Active Comparator group

Description:

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.

Treatment:

Other: Combination Treatment