Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery

Sponsor
West China Hospital
Study ID
NCT07733492
Status
Not Yet Recruiting

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Conditions

  • Non-Small Cell Lung Cancer (NSCLC)
  • Rehabilitation
  • Thoracic Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Wireless Wearable Vital Sign and Activity Monitor — DEVICE
    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 — BEHAVIORAL
    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 — OTHER
    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 Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital Rehabilitation with Wearable Monitoring
    Participants receive standard postoperative rehabilitation education plus a wireless wearable mobile monitoring and digital rehabilitation program for 90 days post-discharge. This includes: (1) continuous vital sign and activity monitoring via a wearable chest patch or wristband (SpO₂, heart rate, respiratory rate, physical activity); (2) individualized digital rehabilitation prescriptions (aerobic, resistance, and inspiratory muscle training) with daily symptom diaries; and (3) remote feedback with threshold-triggered graded responses.
  • Active Comparator: Standard Postoperative Rehabilitation
    Participants receive standard postoperative rehabilitation education, including breathing exercises (abdominal breathing, pursed-lip breathing, effective coughing), progressive walking recommendations, and routine follow-up visits at 1 month and 3 months. No wearable monitoring or digital rehabilitation prescription is provided.

Primary Outcome Measure

FEV1% Predicted at Postoperative Day 90 [ Time Frame: Postoperative day 90 (±14 days) ]

Central Contacts

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