ChiCTR2600117019 版本V1.0 版本创建时间2026/01/19 11:11:27 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600117019 

最近更新日期：

Date of Last Refreshed on：

2026-01-19 11:11:22 

注册时间：

Date of Registration：

2026-01-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于无线可穿戴移动监护设备的非小细胞肺癌术后康复

Public title：

Postoperative Rehabilitation of Non-Small Cell Lung Cancer Based on Wireless Wearable Mobile Monitoring Devices

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于无线可穿戴移动监护设备的非小细胞肺癌术后康复

Scientific title：

Postoperative Rehabilitation of Non-Small Cell Lung Cancer Based on Wireless Wearable Mobile Monitoring Devices

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

林翔 

研究负责人：

廖虎 

Applicant：

Xiang Lin 

Study leader：

Hu Liao 

申请注册联系人电话：

Applicant telephone：

+86 185 5956 2107

研究负责人电话：

Study leader's telephone：

+86 189 8060 5130

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

lhy26cyan@163.com

研究负责人电子邮件：

Study leader's E-mail：

drliaohu@scu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中国四川省成都市武侯区国学巷37号

研究负责人通讯地址：

中国四川省成都市武侯区国学巷37号

Applicant address：

No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan, ChinaNo. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

Study leader's address：

No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

申请注册联系人邮政编码：

Applicant postcode：

610041

研究负责人邮政编码：

Study leader's postcode：

610041

申请人所在单位：

四川大学华西医院

Applicant's institution：

West China Hospital of Sichuan University

研究负责人所在单位：

四川大学华西医院

Affiliation of the Leader：

West China Hospital of Sichuan University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025年审(2643)号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

四川大学华西医院生物医学伦理审查委员会

Name of the ethic committee：

West China Hospital Biomedical Ethics Review Committee of Sichuan University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-30 00:00:00

伦理委员会联系人：

邓绍林

Contact Name of the ethic committee：

Shaolin Deng

伦理委员会联系地址：

中国四川省成都市武侯区国学巷37号

Contact Address of the ethic committee：

No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 85422654

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

四川大学华西医院

Primary sponsor：

West China Hospital of Sichuan University

研究实施负责（组长）单位地址：

中国四川省成都市武侯区国学巷37号

Primary sponsor's address：

No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

四川大学华西医院

具体地址：

中国四川省成都市武侯区国学巷37号

Institution
hospital：

Sichuan University West China Hospital

Address：

No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funding

Target disease：

Non-small cell lung cancer, NSCLC

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

肺癌是我国发病率和死亡率最高的恶性肿瘤之一。据国家癌症中心数据，2022年中国肺癌新发病例约 106.06 万例，占全部恶性肿瘤新发病例的约 22.0%。随着《健康中国2030》战略目标的推进，提高肺癌患者的整体生存质量已成为医疗系统的重要任务。 传感器与移动互联网技术的发展推动了无线可穿戴移动监护在围手术期的应用。该模式可连续采集步行距离、血氧饱和度（SpO?）、心率及心律、呼吸频率与呼吸波形、体温或皮温、活动量与睡眠等多参数，并通过算法识别低氧事件、活动耐量变化与异常生理波动，实现院外阶段的实时风险识别与远程分层管理。与之配套的数字化肺康复包括远程指导的有氧与阻力训练、呼吸肌训练、肺扩张练习以及症状自评与用药管理，已在呼吸系统疾病与胸外科人群中显示出安全、可行并具备功能获益的潜力。其主要目标是增加患者的功能储备，以更好地承受与压力事件(如大手术)相关的影响。围术期管理，尤其是术前预康复与术后康复管理，被认为是改善肺癌患者术后恢复、降低并发症和提高远期生存率的关键环节。然而当前围术期管理多集中于住院阶段，术前评估手段有限、术中监测脱节、术后居家康复依赖患者自觉，缺乏持续数据支持和个性化干预。 在此背景下，融合智能化管理模式的无线可穿戴设备，为肺癌围术期提供了全新的解决思路。本课题拟整合术前6分钟步行试验（6MWT）和围手术期肺功能为核心的可穿戴评估技术与围术期智能化管理平台以及肺癌术前预康复，构建覆盖术前—术中—术后全过程的以可穿戴设备为核心的智能康复管理体系，实现“术前评估—术中监测—术后康复”的一体化智能闭环管理。  

Objectives of Study：

Lung cancer is one of the most prevalent and deadly malignant tumors in China. According to data from the National Cancer Center, approximately 1,060,600 new cases of lung cancer were diagnosed in China in 2022, accounting for about 22.0% of all new malignant tumor cases. With the advancement of the "Healthy China 2030" strategic goals, improving the overall quality of life for lung cancer patients has become a critical mission for the healthcare system. Advances in sensor technology and mobile internet have driven the application of wireless wearable mobile monitoring during the perioperative period. This model enables continuous collection of multiple parameters, such as walking distance, blood oxygen saturation (SpO?), heart rate and rhythm, respiratory rate and waveform, body or skin temperature, activity levels, and sleep quality. Through algorithmic analysis, it can identify hypoxic events, changes in exercise tolerance, and abnormal physiological fluctuations, thereby enabling real-time risk detection and remote stratified management during the post-discharge phase. The accompanying digital pulmonary rehabilitation includes remotely guided aerobic and resistance training, respiratory muscle training, lung expansion exercises, as well as symptom self-assessment and medication management. This approach has demonstrated safety, feasibility, and potential functional benefits in populations with respiratory diseases and thoracic surgery patients. Its primary goal is to enhance patients' functional reserves, enabling them to better withstand the impacts associated with stressful events such as major surgeries. Perioperative management, particularly preoperative prehabilitation and postoperative rehabilitation, is regarded as a key factor in improving postoperative recovery, reducing complications, and enhancing long-term survival rates for lung cancer patients. However, current perioperative management predominantly focuses on the in-hospital phase, with limited preoperative assessment methods, disconnected intraoperative monitoring, and postoperative home rehabilitation reliant on patient self-discipline, lacking continuous data support and personalized interventions. In this context, wireless wearable devices integrated with intelligent management models offer a novel solution for perioperative lung cancer care. This study aims to integrate wearable assessment technologies centered on preoperative 6-minute walk tests (6MWT) and perioperative pulmonary function, an intelligent perioperative management platform, and preoperative prehabilitation for lung cancer. The goal is to establish a wearable device-centered intelligent rehabilitation management system covering the entire preoperative–intraoperative–postoperative continuum, achieving an integrated and intelligent closed-loop management process of "preoperative assessment–intraoperative monitoring–postoperative rehabilitation."

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1) 年龄≥18周岁，≤85周岁。 2) 经组织病理学确诊为原发性非小细胞肺癌（NSCLC），且已完成择期根治性肺叶切除术或肺段切除术。 3) 计划于术后第2至7天内出院，且研究者判断其病情稳定，适合参与该临床研究。 4) 能够独立或在照护者协助下操作智能手机应用程序及可穿戴设备。 5) 自愿参加本研究，并已签署书面的知情同意书。

Inclusion criteria

1) Aged >=18 years and <=85 years. 2) Diagnosed with primary non-small cell lung cancer (NSCLC) confirmed by histopathology, and having completed elective radical lobectomy or segmentectomy. 3) Scheduled for discharge between postoperative days 2 and 7, with the investigator judging the patient’s condition to be stable and suitable for participation in this clinical study. 4) Able to operate smartphone applications and wearable devices independently or with the assistance of a caregiver. 5) Voluntarily agrees to participate in the study and has signed a written informed consent form.

排除标准：

1) 术前即有长期家庭氧疗史，或存在严重的静息状态下呼吸功能障碍或合并严重心肺疾病。 2) 合并严重的、未控制的心脑血管疾病、肝功能不全或肾功能不全。 3) 存在其他严重影响运动功能或依从性的疾病。 4) 已知或疑似对可穿戴设备所用的医用胶或材质有接触性过敏史。 5) 研究者判断存在任何其他不适合参与本研究的情况。

Exclusion criteria：

1) Long-term home oxygen therapy prior to surgery, or the presence of severe resting respiratory dysfunction, or coexisting severe cardiopulmonary diseases. 2) Coexisting severe, uncontrolled cardiovascular or cerebrovascular diseases, hepatic insufficiency, or renal insufficiency. 3) Presence of other diseases that severely affect motor function or compliance. 4) Known or suspected history of contact allergy to the medical adhesive or materials used in the wearable devices. 5) Any other condition considered by the investigator to be unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2026-02-01 00:00:00至 To 2027-09-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-02-01 00:00:00 至 To 2027-08-01 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

63

Group：

Intervention Group

Sample size：

干预措施：

标准围术期治疗 + 可穿戴设备介入的围术期康复

干预措施代码：

Intervention：

Standard Perioperative Treatment Combined with Wearable Device-Assisted Perioperative Rehabilitation

Intervention code：

组别：

对照组

样本量：

63

Group：

Control Group

Sample size：

干预措施：

常规围术期路径管理，无额外康复平台或预康复干预

干预措施代码：

Intervention：

Conventional perioperative pathway management without additional rehabilitation platforms or prehabilitation interventions.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China 

Province：

Sichuan 

City：

 

单位(医院)：

四川大学华西医院 

单位级别：

三甲 

Institution
hospital：

West China Hospital of Sichuan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

FEV1/FVC

指标类型：

主要指标

Outcome：

FEV1/FVC

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后30天与三个月的肺功能的组间差异

指标类型：

主要指标

Outcome：

Between-group differences in lung function at 30 days versus three months after surgery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

六分钟步行试验

指标类型：

次要指标

Outcome：

The six-minute walk test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肺功能

指标类型：

次要指标

Outcome：

Pulmonary function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

围手术期指标

指标类型：

次要指标

Outcome：

Perioperative indicators

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者反馈

指标类型：

次要指标

Outcome：

Feedback from patients

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

平台依从性

指标类型：

次要指标

Outcome：

Compliance with the platform

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 85 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究的随机序列将由独立人员使用计算机随机数字生成程序产生，采用区组随机化方法。分配方案将密封于不透明、按顺序编号的信封中，或存储在中心随机化系统内。研究人员在患者正式入组时，方能打开信封或登录系统获取分组信息。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The randomization sequence for this study will be generated by an independent staff member using a computer-generated random number program, employing the block randomization method. The allocation scheme will be concealed in sequentially numbered, opaque, sealed envelopes or stored within a centralized randomization system. The investigators will open the envelope or access the system to obtain the group assignment only after a patient has been formally enrolled.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

由于干预性质（设备使用与康复程序），受试者和干预实施者（康复指导师）无法设盲，为单盲设计。但结局评估者（肺功能室技师、6分钟步行试验操作员、数据分析统计人员）将对分组信息保持盲态，以最大程度减少测量偏倚。

Blinding：

Due to the nature of the intervention (equipment use and rehabilitation procedures), the participants and the intervention practitioner (rehabilitation trainers) could not be blinded. However, outcome assessors (pulmonary-function laboratory technicians, 6-minute walk test operators, and data analysis statisticians) were blinded to group assignments to minimize measurement bias.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

本研究的临床数据采集和管理工作由两个核心部分组成，以确保数据的完整性、准确性和可溯源性。 1. 病例记录表 研究将设计专用的病例记录表，用于在临床现场原始、同步地记录所有方案要求的数据。CRF的内容严格依据研究方案制定，涵盖受试者筛选、基线特征、干预过程、安全性观察、疗效评估及随访等全部环节。所有CRF数据将由研究人员核对后，及时录入指定的电子数据采集系统。原始的CRF文件将作为源文件，按法规要求进行存档。 2. 电子数据采集和管理系统 本研究将采用基于互联网的电子数据采集系统进行数据的集中化、电子化管理。该系统将提供： 电子化CRF：构建与纸质CRF完全对应的电子表单。 逻辑核查：在数据录入时实时进行逻辑检查、范围核查，以识别潜在错误或遗漏。 权限管理：为不同角色（研究者、数据管理员、监查员）设置差异化的数据访问与操作权限。 数据追踪：系统自动记录所有数据的创建、修改、删除操作，形成完整的稽查轨迹。 中心化存储与备份：所有数据将安全地存储于中央服务器，并定期备份，确保数据安全。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The clinical data collection and management for this study will consist of two core components to ensure data "integrity", "accuracy", and "traceability". 1. Case Record Form A dedicated Case Record Form will be designed for the original and contemporaneous recording of all protocol-required data at the clinical site. The content of the CRF is strictly based on the study protocol, covering all aspects including subject screening, baseline characteristics, intervention process, safety observations, efficacy evaluations, and follow-ups. All CRF data will be verified by research staff and subsequently entered into the designated Electronic Data Capture system in a timely manner. The original CRF documents will be archived as source data in compliance with regulatory requirements. 2. Electronic Data Capture and Management System This study will utilize a web-based Electronic Data Capture system for the centralized and electronic management of data. This system will provide: Electronic CRFs: Creation of electronic forms that fully correspond to the paper CRFs. Logical Checks: Real-time logical and range checks during data entry to identify potential errors or omissions. Access Control: Differentiated data access and operation permissions for various roles (investigators, data managers, monitors). Data Tracking: Automatic logging of all data creation, modification, and deletion activities, generating a complete audit trail. Centralized Storage & Backup: All data will be securely stored on central servers with regular backups to ensure data security.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-01-19 11:11:22