The Construction and Clinical Application of an Integrated Perioperative Management System for Lung Cancer Based on Wearable Devices and Intelligent Platforms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWest China Hospital

About this trial

This study aims to develop and evaluate an integrated perioperative management system based on wearable devices and a digital rehabilitation platform for patients with non-small cell lung cancer (NSCLC) undergoing thoracic surgery. By combining preoperative functional assessment using the six-minute walk test (6MWT), continuous perioperative physiological monitoring, and structured postoperative home-based digital rehabilitation, this randomized controlled trial will investigate whether the wearable-based digital management model improves short-term postoperative pulmonary function, functional recovery, and clinical outcomes compared with standard perioperative care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years and ≤85 years

Pathologically confirmed primary non-small cell lung cancer (NSCLC)

Scheduled to undergo elective curative-intent thoracoscopic lobectomy or segmentectomy

Able to independently operate a smartphone and wearable device, or able to do so with caregiver assistance

Disqualifiers

Preoperative long-term home oxygen therapy or severe resting respiratory failure

Presence of severe or uncontrolled cardiopulmonary disease, cerebrovascular disease, hepatic insufficiency, or renal insufficiency

Severe comorbid conditions that significantly limit physical activity or adherence to rehabilitation

Known or suspected allergy to materials used in wearable devices or medical adhesives

Trial design

Design model

Parallel

Treatments tested in this trial

  • Wearable-Based Digital Perioperative Rehabilitation System

    Device

    This intervention consists of a wearable-based digital perioperative rehabilitation system designed for patients with non-small cell lung cancer undergoing thoracic surgery. The system integrates continuous physiological monitoring, functional assessment, and remote rehabilitation management. During the preoperative phase, patients receive personalized prehabilitation including aerobic exercise, respiratory muscle training, and resistance training. Wearable devices continuously monitor heart rate, oxygen saturation, activity level, and walking distance, including real-time monitoring during the six-minute walk test. Portable pulmonary function testing and functional MRI (PREFUL) are used for baseline assessment. During the postoperative phase, patients receive 30 days of home-based digital rehabilitation, including daily exercise tasks, real-time data upload, electronic patient-reported outcomes, and remote feedback from clinicians via a digital platform. Rehabilitation plans are dynam

  • Standard Perioperative Rehabilitation Guidance

    Behavioral

    This behavioral intervention consists of standard perioperative rehabilitation guidance provided to patients undergoing thoracic surgery for non-small cell lung cancer. Patients receive routine preoperative assessment, standardized postoperative discharge education, and conventional rehabilitation instructions including breathing exercises, early mobilization, pain management, and activity recommendations. No structured prehabilitation program, wearable device monitoring, remote digital platform, or continuous physiological monitoring is provided. Post-discharge follow-up is conducted according to routine outpatient clinical practice.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: Standard Perioperative CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time from return to the ward to first postoperative ambulation

Time, measured in hours, from the patient's return to the surgical ward after surgery to the first postoperative out-of-bed ambulation. First ambulation is defined as the patient getting out of bed and standing or walking, with or without assistance.

Time frame
From return to the surgical ward to first postoperative out-of-bed ambulation, censored at the date of hospital discharge, assessed up to the date of initial discharge (typically up to 14 days post-surgery).

Secondary outcomes

1

Six-Minute Walk Distance (6MWD)

The change in six-minute walk distance will be used to evaluate functional exercise capacity and recovery after surgery.

Time frame
Baseline (preoperative), 30 days after surgery, and 3 months after surgery
2

Change in Forced Expiratory Volume in 1 Second (FEV₁)

Change in forced expiratory volume in 1 second (FEV₁), measured by spirometry, comparing postoperative pulmonary function recovery between the wearable-based digital rehabilitation group and the standard care group. Unit of Measure: Liters (L)

Time frame
Baseline (preoperative), 30 days after surgery, and 3 months after surgery
3

Change in Forced Vital Capacity (FVC)

Change in forced vital capacity (FVC), measured by spirometry, comparing postoperative pulmonary function recovery between the wearable-based digital rehabilitation group and the standard care group.

Time frame
Baseline (preoperative), 30 days after surgery, and 3 months after surgery
4

Change in FEV₁/FVC Ratio

Change in the ratio of forced expiratory volume in 1 second to forced vital capacity (FEV₁/FVC), measured by spirometry, comparing postoperative pulmonary function recovery between the wearable-based digital rehabilitation group and the standard care group.

Time frame
Baseline (preoperative), 30 days after surgery, and 3 months after surgery

Other outcomes

1

Regional Lung Function by Functional MRI (PREFUL)

Regional ventilation and perfusion parameters evaluated by non-contrast functional MRI to assess postoperative regional lung function recovery.

Time frame
Baseline (preoperative), 1 and 3 months after surgery

Sponsors and contacts

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