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RECRUITING
NCT07809763
NA

Wireless Wearable Home Prehabilitation for Older Adults With NSCLC

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

This randomized controlled trial evaluates the efficacy and safety of a home-based prehabilitation program using wireless wearable monitoring devices in older patients (aged 65-85 years) with non-small cell lung cancer scheduled for curative lung resection. Participants are randomized 1:1 to either the intervention group, receiving a personalized exercise regimen (aerobic, resistance, and inspiratory muscle training) with continuous remote monitoring of steps, heart rate, and SpO₂ from 2-4 weeks preoperatively through 90 days postoperatively, or the control group receiving standard perioperative care. The primary endpoint is the between-group difference in FEV₁% predicted at 90 days post-surgery, adjusted for baseline. Secondary endpoints include functional capacity (6-minute walk distance), daily physical activity, hypoxemic burden (time with SpO₂\<90%, nocturnal oxygen desaturation index), patient-reported outcomes (EORTC QLQ-C30/LC13, mMRC), postoperative complications, readmission rates, days alive and at home, and safety outcomes. The target sample size is 198 participants enrolled at West China Hospital of Sichuan University. Anticipated risks include exercise-related musculoskeletal strain, fatigue, and transient cardiopulmonary symptoms, as well as mild skin reactions from devices, all managed through individualized exercise prescriptions, remote safety thresholds, and a graded response protocol.

Official title: Home-Based Prehabilitation Using Wireless Wearable Mobile Monitoring Devices for Elderly Patients With Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

65 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2026-09-10

Completion Date

2028-07-31

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

BEHAVIORAL

Digital Home-Based Prehabilitation

A home-based multimodal prehabilitation and rehabilitation program delivered via a digital health platform, supported by wireless wearable monitoring devices (smartwatch/ring and fingertip pulse oximeter). The intervention includes: (1) moderate-intensity aerobic exercise (≥5 days/week, 30-45 min/session, Borg scale 3-4), (2) inspiratory muscle training (twice daily), (3) functional and chest expansion exercises, and (4) nutritional guidance, smoking cessation advice, and complication education. The program starts 2-4 weeks preoperatively and continues through 90 days post-surgery. Continuous remote monitoring of steps, heart rate, SpO₂, and activity levels with automated safety alerts (e.g., SpO₂\<90% for ≥5 min, step drop ≥40%) triggers a graded clinical response. Participants receive regular remote follow-up and individualized exercise adjustments based on real-time data.

BEHAVIORAL

Standard Perioperative Care

Participants receive the institution's standard enhanced recovery after surgery (ERAS) pathway, including routine preoperative education, postoperative chest physiotherapy, early mobilization guidance, and standard nursing care. No wearable monitoring devices, structured remote exercise prescriptions, digital health platform, or continuous remote supervision are provided. Follow-up visits are scheduled at the same time points as the intervention group for outcome assessment, but no programmatic home-based prehabilitation or tele-monitoring is delivered.

Locations (1)

West China Hospital

Chengdu, Sichuan, China