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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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 mobil
• Другое 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

Первичные конечные точки

• Forced Vital Capacity (FVC) [Срок оценки: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.]
• Forced Expiratory Volume in the first second (FEV₁) [Срок оценки: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.]
• Adherence to therapy [Срок оценки: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.]
• Health-related quality of life (HRQoL) [Срок оценки: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.]
• Satisfaction with the intervention [Срок оценки: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.]

Критерии участия

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Asociación Andaluza de Fibrosis Quística — Seville

Идентификаторы

NCT: NCT06958094 · AAFQFISIO2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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