Wireless Wearable Home Prehabilitation for Older Adults With NSCLC
Recruiting · NCT07809763 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age ≥65 and ≤85 years
- Histopathologically confirmed primary non-small cell lung cancer (NSCLC), scheduled for elective curative-intent lobectomy or segmentectomy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2, or Karnofsky Performance Status (KPS) score ≥70
- Planned admission for surgery within 2 months, and judged by the investigator to have stable disease suitable for participation in a home-based rehabilitation program
- 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, hepatic insufficiency, or renal insufficiency
- Other diseases that seriously 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
Where it is running
1 location listed.
- West China Hospital - Chengdu, Sichuan, China