Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Wireless Wearable Vital Sign and Activity Monitor: Wireless wearable chest patchs or wristband integrating SpO₂, single-lead ECG, respiratory rate, and accelerometer sensors for continuous monitoring of vital signs and physical activity during daily living.

Digital Postoperative Rehabilitation Program: A 90-day home-based digital rehabilitation program delivered via smartphone application, including individualized exercise prescriptions (aerobic walking, resistance training with elastic bands, inspiratory muscle training), daily symptom diaries (cough, sputum, dyspnea), and remote feedback with threshold-triggered alerts and weekly telehealth follow-ups.

Standard Postoperative Rehabilitation Education: Standardized verbal and written postoperative rehabilitation education including breathing exercises (abdominal breathing, pursed-lip breathing, effective coughing), progressive walking recommendations, and routine outpatient follow-up at 1 month and 3 months per institutional practice.

Study summary

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.

Eligibility

Primary outcome measure(s)

• FEV1% Predicted at Postoperative Day 90 — Postoperative day 90 (±14 days)
  Forced expiratory volume in 1 second (FEV1) as a percentage of predicted value, measured by spirometry according to ATS/ERS standards. The best value from at least three acceptable maneuvers is recorded. The between-group difference is analyzed using ANCOVA with baseline FEV1% predicted as covariate.

Trial sites (1)

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