Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery

Overview

This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial evaluating whether a wireless wearable mobile monitoring device combined with a digital rehabilitation program improves pulmonary function at 90 days postoperatively in patients undergoing curative-intent lobectomy or segmentectomy for non-small cell lung cancer (NSCLC). Eligible participants will be randomized to either the intervention group or the control group. Both groups receive standard postoperative rehabilitation education. The intervention group additionally receives a wearable device (chest patch or wristband) for continuous monitoring of SpO₂, heart rate, respiratory rate, and physical activity, along with a smartphone-based digital rehabilitation program including individualized exercise prescriptions (aerobic, resistance, and inspiratory muscle training), daily symptom diaries, and remote feedback with threshold-triggered alerts for up to 90 days after discharge. The control group receives standard rehabilitation education with routine follow-up. The primary endpoint is the between-group difference in FEV1% predicted at postoperative day 90, analyzed using ANCOVA adjusted for baseline FEV1% predicted. Secondary endpoints include FVC% predicted, 6-minute walk distance, daily step count, SpO₂ \<90% time burden, quality of life (EORTC QLQ-C30/LC13, mMRC), 90-day readmission and emergency visit rates, and safety outcomes. A total of 126 participants (63 per group) will be enrolled. The study is being conducted at West China Hospital of Sichuan University from June 2026 to October 2027.

Study Design This is a prospective, single-center, parallel-group, 1:1 randomized controlled superiority trial conducted at West China Hospital of Sichuan University. Enrollment is planned from June 2026 to August 2027, with final data analysis by October 2027. The study protocol has been approved by the local ethics committee (Approval No. 2025-2643, dated December 30, 2025). Study Population We will enroll 126 patients aged 18-85 years with histopathologically confirmed primary NSCLC who have undergone elective curative-intent lobectomy or segmentectomy. Eligible participants must be planned for discharge between postoperative days 2-7, clinically stable for home-based rehabilitation, and able to operate a smartphone and wearable devices independently or with caregiver assistance. Randomization and Blinding Participants are randomized 1:1 using a central web-based block randomization system. This is a single-blind trial: participants and rehabilitation instructors are aware of group assignment, but outcome assessors (pulmonary function technicians, 6MWD operators) and statisticians are blinded to group allocation. Intervention Control group receives standard postoperative rehabilitation education, including breathing exercises and progressive walking recommendations, with routine follow-up at 1 month and 3 months. Intervention group receives, in addition to standard education: (1) a wireless wearable patch or wristband for continuous monitoring of SpO₂, single-lead ECG, respiratory rate, and activity data; (2) a smartphone-based digital rehabilitation program with individualized exercise prescriptions (aerobic, resistance, and inspiratory muscle training) and daily symptom diaries; and (3) remote feedback and threshold-triggered alerts (e.g., SpO₂ \<90% for \>1 minute) with graded clinical responses. Follow-up and Assessments The observation period spans from discharge to postoperative day 90. Assessments include pulmonary function tests (FEV1%, FVC%, FEV1/FVC), 6-minute walk distance, quality of life (EORTC QLQ-C30/LC13, mMRC), continuous physiological monitoring (intervention group only), adherence metrics, and healthcare utilization (readmissions, ED visits, complications). Primary Endpoint The primary endpoint is the FEV1% predicted at postoperative day 90 (±14 days), analyzed by ANCOVA with baseline FEV1% predicted as covariate. Sample Size With two-sided α=0.05, 80% power, an expected between-group difference of 7% in FEV1% predicted, and a pooled standard deviation of 12%, 53 participants per group are required. Accounting for 18% dropout, the final sample size is 126 (63 per group). Statistical Analysis Primary analysis will be performed on the intention-to-treat population using ANCOVA. Secondary continuous endpoints will be analyzed using ANCOVA or repeated-measures ANOVA; categorical endpoints using chi-square or Fisher's exact test. Safety outcomes will be summarized descriptively. A two-sided p-value \<0.05 is considered statistically significant. Safety and Data Quality Adverse events are graded per CTCAE v5.0. Serious adverse events are reported within 24 hours. All study personnel follow standardized operating procedures, and electronic data capture with dual entry and logic checks ensures data quality. Ethics and Dissemination The study is conducted in accordance with the Declaration of Helsinki and Chinese regulations. Written informed consent will be obtained from all participants. Results will be published regardless of outcome.