Rehabilitation With Wearable Monitors for Post-Lung Cancer Surgery

NCT07733492 | Not Yet Recruiting DMC

• 1 other identifier: 2025(2643)
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

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

Outcome Measures

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.

  Postoperative day 90 (±14 days)

Secondary Outcomes (17)

• FVC% Predicted at Postoperative Day 90

  Postoperative day 90 (±14 days)

• FEV1/FVC Ratio at Postoperative Day 90

  Postoperative day 90 (±14 days)

• 6-Minute Walk Distance at Postoperative Day 90

  Postoperative day 90 (±14 days)

• Daily Step Count

  Continuous from discharge to postoperative day 90 (intervention group only)

• Moderate-to-Vigorous Physical Activity (MVPA) Duration

  Continuous from discharge to postoperative day 90 (intervention group only)

Study Arms (2)

Digital Rehabilitation with Wearable Monitoring

EXPERIMENTAL

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.

Device: Wireless Wearable Vital Sign and Activity Monitor; Behavioral: Digital Postoperative Rehabilitation Program

Standard Postoperative Rehabilitation

ACTIVE COMPARATOR

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.

Other: Standard Postoperative Rehabilitation Education

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 Rehabilitation with Wearable Monitoring

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.

Digital Rehabilitation with Wearable Monitoring

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.

Standard Postoperative Rehabilitation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Central Study Contacts

Xuelei ma

CONTACT

+8618708305692; drmaxuelei@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)