Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery

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.

Inclusion criteria

• Age ≥18 and ≤85 years
• Histopathologically confirmed primary non-small cell lung cancer (NSCLC) who have undergone elective curative-intent lobectomy or segmentectomy
• Planned discharge between postoperative day 2 and day 7, and judged by the investigator to be clinically stable and suitable for home-based rehabilitation
• Able to operate a smartphone application and wearable devices independently or with caregiver assistance
• Willing and able to provide written informed consent

Exclusion criteria

• Pre-existing long-term home oxygen therapy, or severe resting respiratory dysfunction
• Concurrent severe, uncontrolled cardiovascular disease, severe hepatic insufficiency, or severe renal insufficiency
• Other diseases or conditions that significantly affect motor function or compliance
• Known or suspected contact allergy to medical adhesives or materials used in the wearable devices
• Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation