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Recruiting
NCT07809763
Wireless Wearable Home Prehabilitation for Older Adults With NSCLC
Conditions: Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery, Prehabilitation
Sex: All
Ages: 65 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 196
Sponsor: West China Hospital
Location: West China Hospital Chengdu Sichuan
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\
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07809763). StuddyBuddy aggregates publicly available trial information.