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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Wireless Wearable Vital Sign and Activity Monitor
DeviceWireless 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
BehavioralA 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
Other interventionStandardized 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.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Digital Rehabilitation with Wearable MonitoringExperimental treatment 2 interventions
Group B: Standard Postoperative RehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
FEV1% Predicted at Postoperative Day 90
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.
Time frame
Postoperative day 90 (±14 days)Secondary outcomes
1
FVC% Predicted at Postoperative Day 90
Forced vital capacity (FVC) as a percentage of predicted value, measured by spirometry at postoperative day 90.
Time frame
Postoperative day 90 (±14 days)2
FEV1/FVC Ratio at Postoperative Day 90
Ratio of FEV1 to FVC, measured by spirometry at postoperative day 90.
Time frame
Postoperative day 90 (±14 days)3
6-Minute Walk Distance at Postoperative Day 90
Total walking distance (in meters) during a 6-minute walk test performed in a 30-meter corridor by a blinded assessor according to standardized protocols.
Time frame
Postoperative day 90 (±14 days)4
Daily Step Count
Mean daily step count derived from the accelerometer of the wearable device, calculated as the average over the 90-day post-discharge period.
Time frame
Continuous from discharge to postoperative day 90 (intervention group only)Sponsors and contacts
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Source ClinicalTrials.gov
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