ChiCTR2600126078 版本V1.0 版本创建时间2026/06/03 14:27:06 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：

 ChiCTR2600126078 

最近更新日期：

Date of Last Refreshed on：

 2026-06-03 14:26:47 

注册时间：

Date of Registration：

 2026-06-03 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

综合干预下急性感染老年患者炎症指标与肌少症发展预后关联研究

Public title：

Study on the correlation between inflammatory markers and sarcopenia development in elderly patients with acute infection under comprehensive intervention

注册题目简写：

English Acronym：

研究课题的正式科学名称：

综合干预下急性感染老年患者炎症指标与肌少症发展预后关联研究

Scientific title：

Study on the correlation between inflammatory markers and sarcopenia development in elderly patients with acute infection under comprehensive intervention

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：

李超楠 

研究负责人：

保志军 

Applicant：

Li Chaonan 

Study leader：

Bao Zhijun 

申请注册联系人电话：

Applicant telephone：

 +86 183 6399 5003

研究负责人电话：

Study leader's
telephone：

+86 139 1713 6990

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：

 23111280017@m.fudan.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 zhijunbao@fudan.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：

上海市静安区延安西路221号

研究负责人通讯地址：

上海市静安区延安西路221号

Applicant address：

No.221, Yan 'an West Road, Jing' an District, Shanghai

Study leader's address：

No.221, Yan 'an West Road, Jing' an District, Shanghai

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

复旦大学附属华东医院

Applicant's institution：

Huadong Hospital affiliated to Fudan University

研究负责人所在单位：

复旦大学附属华东医院

Affiliation of the Leader：

East China Hospital affiliated to Fudan University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 20250125

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：

复旦大学附属华东医院伦理委员会

Name of the ethic committee：

Ethics Committee of Huadong Hospital,Fudan University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-30 00:00:00

伦理委员会联系人：

魏文石

Contact Name of the ethic committee：

Wei Wenshi

伦理委员会联系地址：

上海市静安区延安西路221号

Contact Address of the ethic committee：

No.221, Yan 'an West Road, Jing' an District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 6248 3180

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：

复旦大学附属华东医院

Primary sponsor：

Huadong Hospital affiliated to Fudan University

研究实施负责（组长）单位地址：

上海市静安区延安西路221号

Primary sponsor's address：

No.221, Yan 'an West Road, Jing' an District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

复旦大学附属华东医院

具体地址：

上海市静安区延安西路221号

Institution
hospital：

Huadong Hospital affiliated to Fudan University

Address：

No.221, Yan 'an West Road, Jing' an District, Shanghai

经费或物资来源：

课题经费

Source(s) of funding：

Project funding

研究疾病：

肌少症  

Target disease：

sarcopenia

研究疾病代码：

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：

旨在验证全身炎症状态是老年人群肌少症发展的危险因素，从而为肌少症发展变化及干预策略制定提供了新的参照分子。前瞻性队列研究分析急性住院期间及出院后炎性指标变化情况，对肌少症患者肌力、肌肉质量影响情况，对患者预后及不良结局发生的预测价值。本研究对比多种干预相结合的效果，有助于揭示多种干预方式单独或联合对老年患者恢复的综合影响。这样的多模式干预评估能够提供更全面的见解，以确定哪种方式最能改善患者的整体健康状况。利用机器学习算法建立相关预测模型，利用炎症指标及基线特征预测肌少症发生发展趋势及未来特定时间段内不良事件发生概率。通过机器学习为每个个体提供个性化的风险预测，进而根据患者的特定情况尽早定制预防和治疗计划。  

Objectives of Study：

This study aims to validate that systemic inflammatory status is a risk factor for the development of sarcopenia in the elderly population, thereby providing new molecular references for the progression of sarcopenia and the formulation of intervention strategies. A prospective cohort study was conducted to analyze the changes in inflammatory markers during acute hospitalization and post-discharge, as well as their impact on muscle strength and muscle mass in patients with sarcopenia, and their predictive value for patient prognosis and adverse outcomes. This study compares the effects of multiple interventions, which may help reveal the comprehensive impact of various intervention approaches, either individually or in combination, on the recovery of elderly patients. Such multimodal intervention evaluation can provide a more comprehensive insight into determining which approach best improves the overall health status of patients. Machine learning algorithms were employed to establish predictive models, utilizing inflammatory markers and baseline characteristics to predict the development trend of sarcopenia and the probability of adverse events occurring at specific time points in the future. Through machine learning, personalized risk predictions were provided for each individual, enabling the early customization of prevention and treatment plans based on the patient's specific circumstances.

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≥60 岁的上海老年人群； 2.可参与完成肌少症诊断标准完整筛查流程人群； 3.患者因急性发病住院且相关炎性指标升高； 4.(1)无活动受限及记忆或认知障碍; (2)无严重慢性肝肾疾病； (3)无活动性风湿免疫病； (4)无泌尿系结石； (5)无恶性肿瘤史； (6)无影响骨骼及肌肉代谢过程的其他慢性疾病； (7)无正在使用糖皮质激素; (8)无正在应用其他影响骨骼及肌肉代谢过程的其他药物 ； (9)无严重慢性肝脏胆囊系统疾病；

Inclusion criteria

1. Shanghai elderly population aged 60 years or older; 2. Individuals capable of completing the full screening process for sarcopenia diagnostic criteria; 3. Patients hospitalized due to acute onset with elevated inflammatory markers; 4. (1) No physical limitations or memory/cognitive impairment; (2) No severe chronic liver or kidney disease; (3) No active rheumatic or autoimmune diseases; (4) No urinary tract stones; (5) No history of malignant tumors; (6) No other chronic conditions affecting bone and muscle metabolism; (7) Not currently using glucocorticoids; (8) Not taking any other medications that affect bone and muscle metabolism; (9) No severe chronic liver or gallbladder system diseases.

排除标准：

1.患者拒绝接受肌少症筛查; 2.患者无法进行交流或现有临床资料无法获得有效信息来判断患者状态; 3.拒绝加入研究或临床资料不全的患者; 4.不能接受规律随访者。

Exclusion criteria：

1.Patients who refused to undergo sarcopenia screening; 2. Patients who were unable to communicate or whose existing clinical data could not provide valid information to assess their condition; 3.Patients who declined to participate in the study or had incomplete clinical data; 4.Patients who could not undergo regular follow-up.

研究实施时间：

Study execute time：

从 From 2025-06-01 00:00:00至 To 2027-08-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-10-01 00:00:00 至 To 2027-08-01 00:00:00

干预措施：

Interventions：

组别：

组1

样本量：

 400

Group：

Group 1

Sample size：

干预措施：

抗炎营养联合运动干预

干预措施代码：

Intervention：

Anti-inflammatory diet combined with exercise intervention,

Intervention code：

组别：

组2

样本量：

 400

Group：

Group 2

Sample size：

干预措施：

高蛋白饮食联合运动干预

干预措施代码：

Intervention：

High-protein diet combined with exercise intervention

Intervention code：

组别：

组3

样本量：

 400

Group：

Group 3

Sample size：

干预措施：

单纯运动干预

干预措施代码：

Intervention：

Pure exercise intervention,

Intervention code：

组别：

组4

样本量：

 400

Group：

Group 4

Sample size：

干预措施：

单纯抗炎饮食干预

干预措施代码：

Intervention：

Pure anti-inflammatory diet intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

shanghai

City：

单位(医院)：

 复旦大学附属华东医院 

单位级别：

 三甲 

Institution
hospital：

Huadong Hospital affiliated to Fudan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血常规

指标类型：

主要指标

Outcome：

Routine blood test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

炎性因子

指标类型：

次要指标

Outcome：

Inflammatory factors

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：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 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）：

随机化工具：使用计算机生成的随机数字表或专门的随机化软件（如Sealed Envelope、Randomization.com）进行分组，生成动态区组随机序列，区组大小为4或6（确保组间比例1:1:1:1）。

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

Randomization tools: Grouping was performed using computer-generated random number tables or specialized randomization software (e.g., Sealed Envelope, Randomization.com) to generate dynamic block randomization sequences with block sizes of 4 or 6 (ensuring a 1:1:1:1 intergroup ratio).

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：

为了最大限度地减少观察者和受试者的偏倚，本研究采取了双盲设计，具体步骤如下： 1.受试者盲法： 目标：确保受试者不知道自己接受的是哪种干预方式，或是否属于对照组。 饮食干预设盲：抗炎饮食组与高蛋白饮食组分别给予不同具体食谱推荐，受试者不知具体分组 2.评估者盲法： 目标：确保负责测量结局（如肌力、炎症指标、功能评估）的研究人员不知道受试者的分组情况。 (1) 评估与干预分离 由独立团队进行基线、随访和终点评估，不与干预团队交流受试者的分组信息。评估者不参与任何干预课程的设计或执行。 (2) 标准化评估流程 使用自动化设备（如握力计、步态分析仪）减少人为偏倚。评估时不询问受试者关于干预的细节。 (3) 数据盲法管理 数据库中的分组信息加密存储，仅独立统计团队可访问。中期分析时采用盲态数据审查，避免提前揭盲影响结果。 3.数据盲法：数据分析阶段由独立统计团队完成，直至最终分析前保持盲态。

Blinding：

The specific steps are as follows: 1. Subject blinding: To minimize the biases of both observers and subjects, this study adopted a double-blind design. The specific steps are as follows: Objective: Ensure that the subjects do not know which intervention method they are receiving or whether they belong to the control group. Dietary intervention blinding: Different specific dietary recommendations were given to the anti-inflammatory diet group and the high-protein diet group, and the subjects were unaware of the specific group they belonged to. 2. Examiner blinding: Objective: Ensure that the researchers responsible for measuring the outcomes (such as muscle strength, inflammatory indicators, functional assessment) do not know the group status of the subjects. (1) Separation of assessment and intervention Objective: Ensure that the researchers responsible for measuring the outcomes (such as muscle strength, inflammatory indicators, functional assessment) do not know the subjects' group status. (2) Standardized assessment process During the assessment, the assessors do not ask the subjects about the details of the intervention. The use of automated equipment (such as dynamometers, gait analysis instruments) reduces human bias. (3) Data blind management During the interim analysis, blind data review is used to avoid premature unblinding that could affect the results.The group information in the database is encrypted and stored, and only the independent statistical team can access it. During interim analyses, blind data review is used to avoid premature blinding that could affect the results. 3. Data blindness: The data analysis stage is completed by an independent statistical team, maintaining blind status until the final analysis.

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

是Yes

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）：

由于目前文章尚未发表，待文章发表后可提供共享数据平台,预计日期为2026年12月份。负责人联系方式：23111280017@m.fudan.edu.cn

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

Since the article has not been published yet, the shared data platform will be accessible upon its publication. The contact information of the person in charge is 23111280017@m.fudan.edu.cn

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：

本部分含病例记录表（CRF）和电子数据采集管理系统（EDC）。CRF需明确版本、试验及机构信息，按规范设计填写，涵盖受试者信息、入排标准、检查及不良事件等模块，妥善存储管理。EDC选用ResMan等合规系统，明确部署方式、权限分配及数据共享计划，确保数据录入及时准确，严格遵循GCP及SPIRIT指南，EXCEL仅用于数据传输，不可作为采集管理工具。

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

This section includes Case Report Forms (CRFs) and Electronic Data Collection (EDC) systems. CRFs must specify version, trial, and institutional information, be designed and completed in accordance with regulations, and cover modules such as subject information, inclusion/exclusion criteria, examinations, and adverse events, with proper storage and management. EDC systems such as ResMan compliant systems are selected, with clear deployment methods, permission allocation, and data sharing plans to ensure timely and accurate data entry, strictly adhering to Good Clinical Practice (GCP) and SPIRIT guidelines. EXCEL is only used for data transmission and cannot serve as a data collection management tool.

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：

  2026-06-03 14:26:47