Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWest China Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Wireless Wearable Vital Sign and Activity Monitor
- Digital Postoperative Rehabilitation Program
- Standard Postoperative Rehabilitation Education
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov