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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07765264
Lead Sponsor Delta University for Science and Technology
Conditions
(from sponsor)		 Pediatric Asthma, Chronic Respiratory Diseases, Obstructive Airway Disease
Related terms Lung Diseases, Obstructive
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov