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

NCT07765264 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

  • Pediatric Asthma
  • Chronic Respiratory Diseases
  • Obstructive Airway Disease

Interventions

BEHAVIORAL

Digital-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.

DEVICE

Standard Mechanical Incentive Spirometer

Standard non-gamified three-ball plastic incentive spirometer utilized for daily respiratory exercise with manual logbook recording.

Sponsors & Collaborators

  • Delta University for Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-07-01
Completion
2026-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07765264 on ClinicalTrials.gov