Clinical trial · Interventional
Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery
A Clinical Trial of Postoperative Rehabilitation for Non-Small Cell Lung Cancer Based on Wireless Wearable Mobile Monitoring Devices
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Rehabilitation | — | UNRESOLVED | — |
| Thoracic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Postoperative Rehabilitation Program | Behavioral | — | UNRESOLVED |
| Standard Postoperative Rehabilitation Education | Other | — | UNRESOLVED |
| Wireless Wearable Vital Sign and Activity Monitor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Digital Rehabilitation with Wearable Monitoring
- description
- 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.
- interventionNames
- Device: Wireless Wearable Vital Sign and Activity Monitor
- Behavioral: Digital Postoperative Rehabilitation Program
- type
- ACTIVE_COMPARATOR
- label
- Standard Postoperative Rehabilitation
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
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