The effectiveness of the AI-based RehabLung mobile rehabilitation system on cardiopulmonary function and user satisfaction in lung cancer patients undergoing thoracic surgery: a protocol for a two-arm randomized clinical trial

BACKGROUND Postoperative recovery following lung cancer surgery can be challenging owing to various cardiorespiratory complications. Pulmonary rehabilitation is crucial during both the preoperative and postoperative periods. However, because of limited resources and accessibility, innovative approaches are necessary to improve rehabilitation outcomes. This study aimed to evaluate the effectiveness of the RehabLung App, a novel AI-based mobile application integrating vision recognition, gamified feedback, and web-based patient management to support personalized lung rehabilitation through telerehabilitation and real-time monitoring.

OBJECTIVES This study outlines the protocol for a randomized controlled trial involving patients with lung cancer undergoing thoracic surgery.

DESIGN Assessor-blinded (single-blind), two-arm, parallel-group randomized controlled trial (1:1 allocation) conducted at a single medical center.

METHODS AND ANALYSIS The intervention will include individualized exercise prescriptions delivered five times per week for 8 weeks via the App, which adapts based on weekly assessments of clinical parameters and real-time performance data. Primary outcomes include forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), as well as cardiopulmonary fitness assessed at baseline and at postoperative weeks 5 and 8. Secondary outcomes include respiratory muscle strength, diaphragmatic function, and user satisfaction, which are evaluated using a custom questionnaire informed by technology acceptance models. In addition, clinically meaningful endpoints will be collected, including morbidity, mortality, and length of stay. Frailty will be assessed preoperatively using the Clinical Frailty Scale, and validated patient-reported outcomes (EORTC QLQ-C30) will be administered to evaluate quality of life and symptom burden.

ETHICS The study has been approved by the Institutional Review Board at National Cheng Kung University Hospital (A-ER-111-055).

DISCUSSION We hypothesize that patients using the RehabLung App may demonstrate improvements in pulmonary function, exercise tolerance, diaphragmatic function, and rehabilitation adherence compared with those receiving standard care. The system's real-time feedback and risk alerts may facilitate timely intervention and could potentially improve engagement.

CONCLUSION The implementation of the RehabLung App in lung cancer surgery care may enhance the effectiveness and accessibility of pulmonary rehabilitation. This protocol describes an AI-enhanced telerehabilitation system that may support individualized recovery strategies and could potentially improve both clinical outcomes and patient engagement.

TRIAL REGISTRATION Registration Date;2024,09,19; ClinicalTrials.gov (Identifier: NCT06600503).