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NCT Number: NCT06958094

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

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.

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Key information

Conditions

Cystic Fibrosis (CF) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

8 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asociación Andaluza de Fibrosis Quística

Seville, 41013, Spain

Location contact

Prof. Alvaro Alba Rueda, Master. Current PhD student

CONTACT

[email protected]

+34 744723150

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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).

Treatment and study plan

Gamified mobile health applications

Other
  • 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

Conventional Airway Clearance Therapy

Other
  • 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 treatment

Other
  • 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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Córdoba

Other

Registry information

Official study title

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

Acronym: EGmACT-CF

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 6, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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