The study design is a prospective, non-randomized controlled intervention study involving 588 patients with moderate-to-severe stable COPD (GOLD grades 2-4). The study was conducted at a single institution. Because this is a protocol publication, no results have been reported yet.
Group B received IoT-assisted pulmonary rehabilitation, which included IoT-enabled devices, a smartphone app for home-based pulmonary rehabilitation, daily respiratory muscle training, and structured aerobic/resistance exercise (3-5 sessions/week). Group A served as the comparator, receiving conventional pulmonary rehabilitation with standard education and guidance.
The primary outcome is the 12-month rate of moderate-to-severe AECOPD. Secondary outcomes include pulmonary function, exercise capacity, HRQoL, right cardiac function, pneumonia incidence, all-cause mortality, and adherence. Follow-up assessments are planned for weeks 4, 12, 26, and 52.
Safety data, including adverse events, serious adverse events, and discontinuation rates, were not reported. The study design is limited by its non-randomized nature and single-institution setting. This protocol evaluates a technology-enabled continuous care model to transition from hospital-centric to patient-centric care for chronic respiratory diseases.
View Original Abstract ↓
Pulmonary rehabilitation (PR) constitutes a cornerstone of non-pharmacological management in chronic obstructive pulmonary disease (COPD); however, its clinical effectiveness is frequently attenuated by suboptimal patient adherence and the absence of individualized, continuous monitoring within the home setting. Internet of Things (IoT) technology offers a promising solution to these persistent challenges; however, comprehensive closed-loop management models that fully integrate IoT capabilities remain underexplored. This prospective, non-randomized controlled intervention study will enroll 588 patients with moderate-to-severe stable COPD (GOLD grades 2–4) from a single institution. Participants will be assigned to either conventional PR (Group A) or IoT-assisted PR (Group B) based on initial preference and technology readiness. Group B will receive IoT-enabled devices and a smartphone app to support home-based PR, including daily respiratory muscle training and structured aerobic/resistance exercise (3–5 sessions/week). Group A will receive standard PR education and guidance. Follow-ups will occur at weeks 4, 12, 26, and 52. The primary outcome is the 12-month rate of moderate-to-severe AECOPD. Secondary outcomes include pulmonary function, exercise capacity, HRQoL, right cardiac function, pneumonia incidence, all-cause mortality, and adherence. Analyses will be performed on an intention-to-treat basis. This study will evaluate the efficacy of an IoT-based pulmonary rehabilitation management model in reducing AECOPD-related readmissions and improving exercise tolerance, quality of life, and dyspnea in patients with moderate-to-severe COPD, while examining its feasibility and safety in a real-world setting. The findings may support the development of a technology-enabled continuous care model for chronic respiratory diseases, facilitating the transition from hospital-centric to patient-centric care and advancing the application of smart nursing and remote health management. The study protocol has been registered with the Chinese Clinical Trial Registry (ChiCTR2500106412).