Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis

N/ANot Yet RecruitingNCT06958094

Universidad de Córdoba36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis (CF)

Gamified mobile health applicationsOTHER

* 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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 20 Years

Medical Language ↔ Plain English

* 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).

Outcomes

Primary Outcomes

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.