Clinical trial · Interventional
Wireless Wearable Home Prehabilitation for Older Adults With NSCLC
Home-Based Prehabilitation Using Wireless Wearable Mobile Monitoring Devices for Elderly Patients With Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Prehabilitation | — | UNRESOLVED | — |
| Rehabilitation | — | UNRESOLVED | — |
| Thoracic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Home-Based Prehabilitation | Behavioral | — | UNRESOLVED |
| Standard Perioperative Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Wearable-Based Home Prehabilitation
- description
- Participants receive a wireless wearable monitoring system (smartwatch/ring and fingertip pulse oximeter) to continuously track steps, moderate-to-vigorous physical activity, heart rate, SpO₂, and sleep. A personalized home-based exercise program is prescribed, including moderate-intensity aerobic exercise (≥5 days/week, 30-45 min/session), inspiratory muscle training (twice daily), and functional/chest expansion exercises, starting 2-4 weeks before surgery and continuing until 90 days postoperatively. Remote monitoring with automated safety alerts (e.g., SpO₂\<90% for ≥5 min, step count drop ≥40%) triggers a graded response protocol. Participants also receive nutritional guidance, smoking cessation advice, and complication education. All interventions are delivered via a digital health platform with regular remote follow-up.
- interventionNames
- Behavioral: Digital Home-Based Prehabilitation
- type
- ACTIVE_COMPARATOR
- label
- Standard Perioperative Care
- description
- Participants receive the institution's standard enhanced recovery after surgery (ERAS) pathway, including routine preoperative education, postoperative physical therapy (chest physiotherapy, early mobilization), and standard nursing care. They do not receive the wearable monitoring devices, the structured remote exercise prescription, or the continuous digital supervision. The frequency and content of follow-up visits are identical to those of the intervention group for outcome assessment purposes, but no programmatic home prehabilitation or remote monitoring is provided.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available