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

NCT07765264 | Active Not Recruiting

• 1 other identifier: R-26-08-0015
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Asthma; Chronic Respiratory Diseases; Obstructive Airway Disease

Keywords

Gamification; Pediatrics; Spirometry; Telehealth; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1)

  Measured in liters (L) using a clinical-grade smart pocket spirometer to evaluate dynamic lung function and expiratory flow improvement.

  Baseline, Week 6 (midpoint), and Week 12 (study exit)

• Change from Baseline in Forced Vital Capacity (FVC)

  Measured in liters (L) via spirometry to evaluate total capacity of air forcefully exhaled following maximum inhalation.

  Baseline, Week 6 (midpoint), and Week 12 (study exit)

• Change from Baseline in FEV1/FVC Ratio

  Calculated as the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (expressed as a percentage) to assess airway obstruction severity

  Baseline, Week 6 (midpoint), and Week 12 (study exit)

Secondary Outcomes (1)

• Treatment Adherence Rate

  Continuously over 12 weeks

Study Arms (2)

Intervention Group (DGDT)

EXPERIMENTAL

Participants undergo a 12-week home-based protocol using an open-access interactive gamified breathing application on a mobile device for 15 minutes twice daily.

Behavioral: Digital-Gamified Diaphragmatic Training (DGDT)

Control Group (Standard Care)

ACTIVE COMPARATOR

Participants perform 12 weeks of standard home-based respiratory exercise using a traditional 3-ball mechanical incentive spirometer for 15 minutes twice daily.

Device: Standard Mechanical Incentive Spirometer

Interventions

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.

Intervention Group (DGDT)

Standard Mechanical Incentive Spirometer DEVICE

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

Control Group (Standard Care)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- Occurrence of an acute pulmonary exacerbation, status asthmaticus, or respiratory tract infection requiring hospitalization within the last 30 days.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Outpatient Pediatric Pulmonology Clinics, Damietta

Damietta, 1234, Egypt

Location

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts and clinical outcome assessors conducting the spirometric evaluations at baseline, Week 6, and Week 12 are fully blinded to participant allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 allocation parallel-group trial comparing a 12-week Digital-Gamified Diaphragmatic Training (DGDT) home protocol against standard mechanical incentive spirometry.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 14, 2026
• Study Start: April 1, 2026
• Primary Completion: July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available beginning 6 months following primary publication and will remain accessible for up to 3 years.
• Access Criteria: Requests must be directed to the Principal Investigator via email with a formally approved scientific proposal and data transfer agreement. All shared data will remain strictly anonymized in accordance with institutional IRB privacy guidelines.

Locations

EG (1)