Chronic Respiratory Diseases, Obstructive Airway Disease, Pediatric Asthma
Conditions
Keywords
Gamification, Pediatrics, Spirometry, Telehealth, Pulmonary Rehabilitation
Brief summary
Adherence to traditional pediatric pulmonary rehabilitation exercises is often low due to their repetitive nature, leading to poor respiratory outcomes. Digital-Gamified Diaphragmatic Training (DGDT) integrates real-time biofeedback into smartphone applications to turn breathing exercises into interactive games, encouraging children to practice more consistently. The purpose of this prospective, randomized controlled clinical trial is to evaluate the clinical efficacy of a 12-week home-based DGDT protocol compared to standard mechanical incentive spirometry among pediatric patients aged 6 to 14 years with chronic respiratory conditions. The primary goal is to assess changes in key spirometric parameters-specifically Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC), and the FEV1/FVC ratio-to determine if gamified digital training offers physiological benefits over standard rehabilitation methods.
Detailed description
Pediatric patients with chronic restrictive or obstructive pulmonary conditions often face challenges maintaining compliance with home rehabilitation regimens. This multi-center, parallel-group randomized clinical trial (1:1 allocation ratio) evaluates whether a low-cost, decentralized digital application can improve objective pulmonary metrics and exercise adherence in pediatric cohorts. Study Procedures: Eligible participants aged 6-14 years are randomized to either the DGDT Intervention Group or the Standard Control Group. Intervention Group: Participants download an open-access interactive gamified breathing application on their household smartphone. Patients perform guided diaphragmatic breathing for 15 minutes twice daily for 12 weeks. The application provides real-time acoustic/visual feedback to promote controlled inhalation and prolonged exhalation while logging compliance data. Control Group: Participants receive standard three-ball mechanical incentive spirometers and perform an identical schedule (15 minutes, twice daily for 12 weeks) with manual logbook tracking. Outcome Evaluation & Biosafety: Spirometric assessments are conducted at baseline, Week 6 (midpoint), and Week 12 (study exit) across outpatient pediatric clinics. To optimize resources and biosafety, baseline and follow-up clinical testing utilize a centralized clinical-grade smart pocket spirometer (MIR Spirobank Smart) with single-use disposable cardboard/plastic mouthpieces and medical-grade sterilization between tests. Statistical Plan: Changes in FEV1, FVC, and FEV1/FVC ratios from baseline to 6 and 12 weeks will be analyzed using Repeated Measures Analysis of Variance (RM-ANOVA), following an Intent-to-Treat (ITT) approach.
Interventions
BEHAVIORALDigital-Gamified Diaphragmatic Training (DGDT)
Interactive mobile application providing real-time biofeedback and acoustic/visual gamification mechanics to guide slow, deep diaphragmatic breathing and prolonged exhalations.
DEVICEStandard Mechanical Incentive Spirometer
Standard non-gamified three-ball plastic incentive spirometer utilized for daily respiratory exercise with manual logbook recording.
Sponsors
Delta University for Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analysts and clinical outcome assessors conducting the spirometric evaluations at baseline, Week 6, and Week 12 are fully blinded to participant allocation.
Intervention model description
1:1 allocation parallel-group trial comparing a 12-week Digital-Gamified Diaphragmatic Training (DGDT) home protocol against standard mechanical incentive spirometry.
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients aged 6 to 14 years at the time of screening. * Documented clinical diagnosis of a chronic respiratory condition (e.g., bronchial asthma, post-inflammatory pulmonary conditions), stable under standard pharmacological management for at least 4 consecutive weeks. * Household access to a functional smartphone (Android or iOS) capable of running mobile applications. * Written informed consent provided by a parent or legal guardian, and child's verbal or written assent.
Exclusion criteria
\- Occurrence of an acute pulmonary exacerbation, status asthmaticus, or respiratory tract infection requiring hospitalization within the last 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline, Week 6 (midpoint), and Week 12 (study exit) | Measured in liters (L) using a clinical-grade smart pocket spirometer to evaluate dynamic lung function and expiratory flow improvement. |
| Change from Baseline in Forced Vital Capacity (FVC) | Baseline, Week 6 (midpoint), and Week 12 (study exit) | Measured in liters (L) via spirometry to evaluate total capacity of air forcefully exhaled following maximum inhalation. |
| Change from Baseline in FEV1/FVC Ratio | Baseline, Week 6 (midpoint), and Week 12 (study exit) | Calculated as the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (expressed as a percentage) to assess airway obstruction severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Adherence Rate | Continuously over 12 weeks | Percentage of completed diaphragmatic breathing training sessions logged digitally via the mobile application (intervention group) or manually via logbooks (control group) |
Countries
Egypt
Outcome results
None listed