Home-Based Prehabilitation Using Wireless Wearable Mobile Monitoring Devices for Elderly Patients With Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- FEV₁% Predicted at 90 Days Post-Surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
In this assessor-blinded trial, participants and the research team delivering the intervention cannot be masked due to the nature of the intervention (wearable devices vs. standard care). However, all outcome assessors responsible for the primary and key secondary endpoints-specifically the technicians performing pulmonary function tests (spirometry) and the physical therapists conducting the 6-minute walk tests-are fully masked to group allocation. These assessors are not involved in randomization, intervention delivery, or remote monitoring, and they remain blinded throughout all follow-up assessments to minimize detection bias.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Wearable-Based Home Prehabilitation
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.
干预措施: Digital Home-Based Prehabilitation (Behavioral)
Standard Perioperative Care
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.
干预措施: Standard Perioperative Care (Behavioral)
结局指标
主要结局
FEV₁% Predicted at 90 Days Post-Surgery
时间窗: 90 days after surgery (±14 days)
Forced expiratory volume in 1 second as a percentage of the predicted value, measured by spirometry according to ATS/ERS standards. The measurement is taken at the 90-day (±14 days) follow-up visit. The primary analysis compares the adjusted between-grou
次要结局
- Change From Baseline in FVC Percent Predicted(Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days)
- Change From Baseline in FEV1/FVC Ratio(Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days)
- Change From Baseline in 6-Minute Walk Distance(Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days)
- Change in Borg Dyspnea Score During the 6-Minute Walk Test(Baseline, 30 days after surgery with an allowable window of ±7 days, and 90 days after surgery with an allowable window of ±14 days)
- Mean Daily Step Count(Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90)
- Mean Daily Moderate-to-Vigorous Physical Activity(Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90)
- Percentage of Monitoring Time With SpO2 Below 90%(Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90)
- Incidence of All-Cause Hospital Readmission Within 90 Days(Within 90 days after surgery)
- Nocturnal Oxygen Desaturation Index(Baseline through 90 days after surgery, summarized separately for postoperative days 0-30 and 31-90)
- Change From Baseline in EORTC QLQ-C30 Score(Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days)
- Change From Baseline in EORTC QLQ-LC13 Score(Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days)
- Change From Baseline in mMRC Dyspnea Scale Score(Baseline to 30 days after surgery, with an allowable window of ±7 days, and baseline to 90 days after surgery, with an allowable window of ±14 days)
- Incidence of Emergency Department Visits Within 90 Days(Within 90 days after surgery)
- Incidence of Postoperative Pulmonary Complications Within 90 Days(Within 90 days after surgery)
- Days Alive and at Home During the First 90 Days After Surgery(Within 90 days after surgery)
- Incidence of Adverse Events(From signing informed consent through 90 days after surgery)
- Incidence of Serious Adverse Events(From signing informed consent through 90 days after surgery)
研究者
Xuelei Ma MD
Clinical Professor
West China Hospital