Overview
This study aims to develop and evaluate an integrated perioperative management system based on wearable devices and a digital rehabilitation platform for patients with non-small cell lung cancer (NSCLC) undergoing thoracic surgery. By combining preoperative functional assessment using the six-minute walk test (6MWT), continuous perioperative physiological monitoring, and structured postoperative home-based digital rehabilitation, this randomized controlled trial will investigate whether the wearable-based digital management model improves short-term postoperative pulmonary function, functional recovery, and clinical outcomes compared with standard perioperative care.
Description
With the rapid development of wearable sensor technology and digital health platforms, continuous physiological monitoring and remote rehabilitation have become feasible throughout the perioperative period. However, current perioperative management for lung cancer patients remains fragmented, with limited integration of preoperative functional assessment, intraoperative monitoring, and postoperative home-based rehabilitation. This study is designed to establish and validate a comprehensive wearable-based perioperative management system for patients with non-small cell lung cancer (NSCLC) undergoing surgical resection.
This study is a prospective, single-center, randomized, single-blind, superiority-controlled trial. A total of 126 eligible patients undergoing elective video-assisted thoracoscopic lobectomy or segmentectomy will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The control group will receive standard perioperative management and routine postoperative rehabilitation guidance. The intervention group will receive standard care plus a digital perioperative rehabilitation program supported by wearable devices and a remote monitoring platform.
During the preoperative phase, patients in the intervention group will undergo personalized prehabilitation including aerobic exercise training, respiratory muscle training, and resistance exercise. The six-minute walk test (6MWT), portable pulmonary function testing, and non-contrast functional lung MRI (PREFUL technology) will be performed for functional assessment. Wearable devices will continuously collect heart rate, blood oxygen saturation, step count, and activity level.
During the intraoperative phase, standardized surgical procedures and anesthetic management will be applied. Key intraoperative indicators including blood loss, ventilation time, anesthesia duration, and complications will be recorded through the anesthesia and surgical information systems.
During the postoperative phase, patients in the intervention group will receive 30-day home-based digital rehabilitation, including daily exercise tasks, real-time wearable data upload, electronic patient-reported outcomes (ePROs) reporting of symptoms (pain, fatigue, dyspnea), and remote review and guidance by medical staff via the digital platform. The control group will receive routine discharge education and outpatient follow-up.
The primary endpoint of the study is the between-group difference in pulmonary function (FEV₁) at 30 days and 3 months after surgery. Secondary endpoints include six-minute walk distance, peak oxygen consumption (VO₂ peak), postoperative complications, chest tube duration, length of hospital stay, time to first ambulation, 30-day readmission rate, analgesic consumption, symptom burden assessed using the MD Anderson Symptom Inventory-Lung Cancer module (MDASI-LC), and rehabilitation adherence based on platform usage data.
By integrating wearable-based continuous monitoring, objective functional assessment, and structured digital rehabilitation, this study aims to establish a closed-loop, data-driven perioperative management model. The results are expected to provide high-quality clinical evidence for the effectiveness, safety, and feasibility of wearable-assisted perioperative rehabilitation in lung cancer patients, and to promote the clinical translation of digital health technologies into thoracic surgery practice.
Eligibility
Inclusion Criteria:
- Age ≥18 years and ≤85 years
- Pathologically confirmed primary non-small cell lung cancer (NSCLC)
- Scheduled to undergo elective curative-intent thoracoscopic lobectomy or segmentectomy
- Able to independently operate a smartphone and wearable device, or able to do so with caregiver assistance
- Willing to comply with study procedures and follow-up requirements
- Provided written informed consent prior to participation
Exclusion Criteria:
- Preoperative long-term home oxygen therapy or severe resting respiratory failure
- Presence of severe or uncontrolled cardiopulmonary disease, cerebrovascular disease, hepatic insufficiency, or renal insufficiency
- Severe comorbid conditions that significantly limit physical activity or adherence to rehabilitation
- Known or suspected allergy to materials used in wearable devices or medical adhesives
- Any other condition that, in the judgment of the investigators, makes the participant unsuitable for study participation
