Clinical and Autonomic Efficacy of Digital-Gamified Diaphragmatic Training in Pediatric Pulmonary Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysts and clinical outcome assessors conducting the spirometric evaluations at baseline, Week 6, and Week 12 are fully blinded to participant allocation.
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •- Occurrence of an acute pulmonary exacerbation, status asthmaticus, or respiratory tract infection requiring hospitalization within the last 30 days.
研究组 & 干预措施
Intervention Group (DGDT)
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.
干预措施: Digital-Gamified Diaphragmatic Training (DGDT) (Behavioral)
Control Group (Standard Care)
Participants perform 12 weeks of standard home-based respiratory exercise using a traditional 3-ball mechanical incentive spirometer for 15 minutes twice daily.
干预措施: Standard Mechanical Incentive Spirometer (Device)
结局指标
主要结局
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1)
时间窗: 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)
时间窗: 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
时间窗: 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
次要结局
- Treatment Adherence Rate(Continuously over 12 weeks)