Clinical and Autonomic Efficacy of Digital-Gamified Diaphragmatic Training in Pediatric Pulmonary Rehabilitation

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.

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.