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.

• Digital-Gamified Diaphragmatic Training (DGDT) (Behavioral): Interactive mobile application providing real-time biofeedback and acoustic/visual gamification mechanics to guide slow, deep diaphragmatic breathing and prolonged exhalations.
• Standard Mechanical Incentive Spirometer (Device): Standard non-gamified three-ball plastic incentive spirometer utilized for daily respiratory exercise with manual logbook recording.

Primary outcomes

• 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 outcomes

• 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)

Sex: All, ages: 6 Years to 14 Years

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.

• Study Protocol (PDF, 2026-08-01)