ChiCTR2600124126 版本V1.0 版本创建时间2026/05/07 16:54:23 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：

 ChiCTR2600124126 

最近更新日期：

Date of Last Refreshed on：

 2026-05-07 16:53:54 

注册时间：

Date of Registration：

 2026-05-07 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

多模态超声评估老年肌少症的应用价值

Public title：

Application value of multimodal ultrasound in the evaluation of senile oligomyopathy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

多模态超声评估老年肌少症的应用价值

Scientific title：

Application value of multimodal ultrasound in the evaluation of senile oligomyopathy

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：

吴日暖 

研究负责人：

吴日暖 

Applicant：

Wu Rinuan 

Study leader：

Wu Rinuan 

申请注册联系人电话：

Applicant telephone：

 +86 184 8987 0738

研究负责人电话：

Study leader's
telephone：

+86 184 8987 0738

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：

 945855805@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 945855805@qq.com

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：

海南省海口市秀英区秀华路19号

研究负责人通讯地址：

海南省海口市秀英区秀华路19号

Applicant address：

No. 19 Xiuhua Road, Xiuying District, Haikou City, Hainan Province

Study leader's address：

No. 19 Xiuhua Road, Xiuying District, Haikou City, Hainan Province

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：

海南省人民医院

Applicant's institution：

Hainan Provincial people's Hospital

研究负责人所在单位：

海南省人民医院

Affiliation of the Leader：

Hainan Provincial people's Hospital

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：

 EC-YLY-2026-28-01

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：

海南省人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Hainan Provincial people's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-02-06 00:00:00

伦理委员会联系人：

王卫林

Contact Name of the ethic committee：

Wang Weilin

伦理委员会联系地址：

海南省海口市秀英区秀华路19号

Contact Address of the ethic committee：

No. 19 Xiuhua Road, Xiuying District, Haikou City, Hainan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 898 6862 2476

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：

海南省人民医院

Primary sponsor：

Hainan Provincial people's Hospital

研究实施负责（组长）单位地址：

海南省海口市秀英区秀华路19号

Primary sponsor's address：

No. 19 Xiuhua Road, Xiuying District, Haikou City, Hainan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

海南省

市(区县)：

海口市

Country：

China

Province：

Hainan

City：

Haikou

单位(医院)：

海南省人民医院

具体地址：

海南省海口市秀英区秀华路19号

Institution
hospital：

Hainan Provincial people's Hospital

Address：

No. 19 Xiuhua Road, Xiuying District, Haikou City, Hainan Province

经费或物资来源：

自筹

Source(s) of funding：

Self-financing

研究疾病：

肌少症  

Target disease：

Myasthenia

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

了解老年患者发生肌少症的影响因素，通过分析老年患者中肌少症组与非肌少症组超声指标差异及与临床肌少症诊断标准各参数之间的相关性，探讨超声在老年患者肌少症诊断中的有效性及可靠性。  

Objectives of Study：

To explore the effectiveness and reliability of ultrasound in the diagnosis of myometriosis in elderly patients, the difference of ultrasonic indexes in the disease group and the correlation between the ultrasonic indexes and the diagnostic criteria of clinical myomyositis were discussed.

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.年龄大于 60 岁； 2.无下肢创伤或手术史； 3.无障碍自主站立行走； 4.均知情同意。

Inclusion criteria

1. More than 60 years old; 2. No history of lower limb trauma or operation; 3. Barrier-free standing and walking; 4. Informed consent.

排除标准：

1.肌肉相关性疾病：肌炎、重症肌无力、帕金森病、脑卒中； 2.严重影响肌肉代谢性疾病：甲亢或甲减、恶性肿瘤等； 3.严重精神障碍疾病。

Exclusion criteria：

1. Muscle-related diseases: myositis, myasthenia gravis, Parkinson's disease, stroke; 2. Seriously affecting muscle metabolic diseases: hyperthyroidism or hypothyroidism, malignant tumor, etc.; 3. Severe mental disorders.

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2026-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-10 00:00:00 至 To 2026-12-30 00:00:00

干预措施：

Interventions：

组别：

组1（肌少症组）：符合亚洲肌少症工作组（AWGS）2019诊断标准的老年患者

样本量：

 40

Group：

Group 1 (sarcopenia group): elderly patients who meet the diagnostic criteria of the Asian Working Group for Sarcopenia (AWGS) 2019

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

组2（对照组）：年龄、性别匹配且无肌少症的健康老年人

样本量：

 55

Group：

Group 2 (control group): healthy older adults matched for age and sex without sarcopenia

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 海南省 

市(区县)：

 海口市 

Country：

China

Province：

Hainan province

City：

Haikou City

单位(医院)：

 海南省人民医院 

单位级别：

 三级甲等 

Institution
hospital：

Hainan Provincial people's Hospital

Level of the institution：

Grade?A Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

性别

指标类型：

次要指标

Outcome：

Sex

Type：

Secondary indicator

测量时间点：

任何时间段

测量方法：

病史询问

Measure time point of outcome：

Any period of time

Measure method：

Medical history inquiry

指标中文名：

年龄(y)

指标类型：

次要指标

Outcome：

age

Type：

Secondary indicator

测量时间点：

任何时间段

测量方法：

病史询问

Measure time point of outcome：

Any period of time

Measure method：

Medical history inquiry

指标中文名：

身高（cm）

指标类型：

次要指标

Outcome：

height(cm)

Type：

Secondary indicator

测量时间点：

任何时间段

测量方法：

人体成分分析仪测量

Measure time point of outcome：

Any period of time

Measure method：

Measurement by human body composition analyzer

指标中文名：

体重（kg）

指标类型：

次要指标

Outcome：

weight

Type：

Secondary indicator

测量时间点：

任何时间段

测量方法：

人体成分分析仪测量

Measure time point of outcome：

Any period of time

Measure method：

Measurement by human body composition analyzer

指标中文名：

5次起坐测试时间（s）

指标类型：

次要指标

Outcome：

5 sit-up test time(s)

Type：

Secondary indicator

测量时间点：

任何时间段

测量方法：

受试者坐在一个高约43cm的椅子上，保持双臂交叉抱肩或放于胸前姿势，用最快的速度连续完成5次起坐，结果以秒为单位，精确到0.01s。

Measure time point of outcome：

Any period of time

Measure method：

The subjects sat on a chair about 43cm high, keeping their arms folded around their shoulders or placed in front of their chest, and sat up for five consecutive times with the fastest speed. The results were accurate to 0.01s in seconds.

指标中文名：

6米步速测试时间（s）

指标类型：

次要指标

Outcome：

6m walking speed test time

Type：

Secondary indicator

测量时间点：

任何时间段

测量方法：

在平直地面上分别标记0m及6m位置，以患者单脚迈出起点开始计时，匀速前进，双脚迈过终点结束计时，记作t（秒），计算老年患者6m步行速度（步速=6/t）；每名患者各测量两次，每次测量间隔30秒，计算平均值，精确到0.01s。

Measure time point of outcome：

Any period of time

Measure method：

The positions of 0m and 6m were marked on the flat ground respectively, the starting time was measured with one foot stepping out of the starting point, moving forward at a uniform speed, and the end time was recorded as t (seconds), and the walking speed of 6m in elderly patients was calculated (walking speed = 6Sig). Each patient was measured twice with an interval of 30 seconds, and the average value was calculated to be accurate to 0.01 s.

指标中文名：

握力测试

指标类型：

次要指标

Outcome：

Grip strength test(kg)

Type：

Secondary indicator

测量时间点：

任何时间段

测量方法：

受试者取站立位，掌心向内，上肢伸直与身体成15-30度的夹角;用优势手最大力握住仪器握柄，测量2次，两次间隔至少5分钟，取较大值，结果以kg为单位，精确到0.1kg。

Measure time point of outcome：

Any period of time

Measure method：

The subjects stood with the palms inward, and the upper limbs straightened at an angle of 15-30 degrees with the body. hold the handle of the instrument most vigorously with the dominant hand, measured twice, with an interval of at least 5 minutes, taking a larger value, and the results were accurate to 0.1kg in kg.

指标中文名：

四肢骨骼肌质量指数（ASMI）

指标类型：

次要指标

Outcome：

Appendicularskeletalmusclemassindex,ASMI

Type：

Secondary indicator

测量时间点：

任何时间段

测量方法：

采用基于多频生物电阻抗分析原理的人体成分分析仪， 对所有研宄对象进行测量。 要求受试者尽量着装轻薄，不携带金属物品， 在测量前应排空大小便。 测量之前输入受试者年龄、 性别、 身高等信息，对人体成分仪踏板和握臂电极触片进行酒精消毒和适度湿润处理， 受试者需赤足站立于人体成分仪指定位置， 首先稳定身体以精准测量体重， 双脚应分别置于踏板的电极触片之上， 并留意前脚掌与后脚跟是否均与电极完全贴合， 如有未完全接触的情况， 需微调站姿。 同时双手应分别握住握臂上的电极触片， 并确保大拇指与其余四指均能与相应电极触片有效接触。 运行人体成分检查软件， 进行人体成分分析。

Measure time point of outcome：

Any period of time

Measure method：

All the subjects were measured by a human body composition analyzer based on the principle of multi-frequency bioelectrical impedance analysis. The subjects were required to dress thinly as far as possible, do not carry metal objects, and emptying their stools before measurement. Input information such as age, sex and height of the subjects before measurement, and disinfect the pedals and arm-holding electrode contacts of the body composition meter with alcohol and properly moisturize them. The

指标中文名：

测量股直肌伸直和屈膝90°状态下的肌肉厚度（MT直、MT弯曲）

指标类型：

主要指标

Outcome：

Measure the muscle thickness of rectus femoris muscle under the condition of straightening and knee flexion 90 °(MT straight, MT bending)

Type：

Primary indicator

测量时间点：

任何时间段

测量方法：

使用二维灰阶超声分别依次测量双下肢伸展放松和下肢屈膝90°状态下的肌肉厚度， 体表定位在髂前上棘和髌骨上缘连线二分之一距离处， 均探测股直肌的最大厚度。 所有数据精确到0.01cm， 重复测量３次取平均值。

Measure time point of outcome：

Any period of time

Measure method：

Two-dimensional gray-scale ultrasound was used to measure the muscle thickness of both lower limbs under the condition of extension and relaxation and knee flexion of 90 °, respectively. The body surface was located at 1/2 distance between the anterior superior iliac spine and the superior edge of patella, and the maximum thickness of rectus femoris was detected. All the data are accurate to 0.01cm, and the average value is obtained by repeated measurement for 3 times.

指标中文名：

测量股直肌伸直和屈膝90°状态下的肌肉横截面积（CSA直、CSA弯曲）

指标类型：

主要指标

Outcome：

Measure the cross-sectional area of rectus femoris muscle under the condition of straightening and knee flexion 90 °(CSA straight, CSA bending)

Type：

Primary indicator

测量时间点：

任何时间段

测量方法：

使用二维灰阶超声分别依次测量双下肢伸展放松和下肢屈膝90°状态下的肌肉横截面积，体表定位在髂前上棘和髌骨上缘连线二分之一距离处，均探测股直肌的最大横截面积。所有数据精确到0.01cm２，均重复测量３次取平均值。

Measure time point of outcome：

Any period of time

Measure method：

Two-dimensional gray scale ultrasound was used to measure the muscle cross-sectional area of both lower limbs under the condition of extension and relaxation and knee flexion of 90 °, respectively. The body surface was located at the 1/2 distance between the anterior superior iliac spine and the superior edge of the patella, and the maximum cross-sectional area of the rectus femoris was detected. All the data were accurate to 0.01cm2 and were measured repeatedly for 3 times to take the average v

指标中文名：

测量股直肌伸直和屈膝90°状态下的微血流血流速度（MV直、MV弯曲）

指标类型：

主要指标

Outcome：

The microvascular blood flow velocities of rectus femoris muscle extension and knee flexion 90 °(MV straight, MV bending) were measured.

Type：

Primary indicator

测量时间点：

任何时间段

测量方法：

让受试者分别依次保持双下肢伸展放松和下肢屈膝90°，在上述相同体表位置将超声探头垂直于股直肌纵轴作横向扫描，调节参数至图像质量最佳，启动微血流成像模式，选择速度标尺为2cm/s，PW测量MV，保存图像，重复测量３次取平均值。

Measure time point of outcome：

Any period of time

Measure method：

The subjects were asked to keep both lower limbs stretched and relaxed and knee flexion 90 °respectively. The ultrasonic probe was scanned laterally perpendicular to the longitudinal axis of rectus femoris at the same body surface position, the parameters were adjusted to the best image quality, and the micro-blood flow imaging mode was started. The speed scale was 2cmPW to measure MV, the image was saved, and the average value was measured for 3 times.

指标中文名：

测量股直肌伸直和屈膝90°状态下的肌肉弹性模量值（E直、E弯曲）

指标类型：

主要指标

Outcome：

Measure the elastic modulus of the rectus femoris muscle under the condition of 90 °knee flexion and extension (E straight, E bending).

Type：

Primary indicator

测量时间点：

任何时间段

测量方法：

使用剪切波弹性成像模式测量股直肌弹性模量，让受试者分别依次保持双下肢伸展放松和下肢屈膝90°，在上述相同体表位置将超声探头垂直于股直肌纵轴作横向扫描， 弹性成像深度３~4cm， 沿股直肌纵切面方向检查测量股直肌纵切面弹性模量值。设置SWE感兴趣区域大小（ROI）（直径= 10 mm）。系统自动计算出Ｑ-box区域内肌肉的平均弹性模量值、 最大弹性模量值和最小弹性模量值（kPa）， 选择平均弹性模量值进行统计。

Measure time point of outcome：

Any period of time

Measure method：

The elastic modulus of rectus femoris was measured by shear wave elastography mode, and the subjects were asked to keep both lower limbs stretched and relaxed and knee flexion 90 °respectively. The ultrasonic probe was scanned laterally perpendicular to the longitudinal axis of rectus femoris at the same body surface position, and the elastic modulus of rectus femoris longitudinal section was measured along the longitudinal section of rectus femoris. 3~4cm. Sets the size of the SWE region of int

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 65 岁 years
最大 Max age 80 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

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）：

本研究计划在主要结果发表后12个月内，共享去标识化的个体参与者数据。数据将包括基线特征、主要和次要结局指标。研究者需向主要研究者提交研究方案并获得批准，签署数据使用协议后方可获取数据。数据将开放获取5年。

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

This study plans to share de-identifiable individual participant data within 12 months after the main results are published. The data will include baseline characteristics, primary and secondary outcome indicators. Researchers need to submit the research plan to the key researchers and obtain approval, and the data can be obtained only after signing the data use agreement. The data will be available for five years.

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：

数据采集工具：采用标准化病例报告表（CRF）采集数据。CRF根据CDASH标准设计，包含受试者人口学信息（性别、年龄、身高、体重）、多模态超声参数（肌肉厚度（MT直、MT弯曲）、横截面积（CSA直、CSA弯曲）、微血管血流速度（MV直、MV弯曲）、弹性模量（E直、E弯曲））、金标准诊断指标（BIA测定的ASMI、握力、6米步速时间、5次起坐测试时间）。 数据管理方式：采用电子数据采集系统（如REDCap）进行数据管理。实行双人独立录入，系统内置逻辑核查程序，对异常值和缺失值自动发出疑问。所有数据修改保留完整的审计轨迹。 数据质量控制：1.超声检查由2名经过培训的医师独立操作，对金标准结果保持盲态； 2.定期进行数据监查，核查CRF数据与原始病历的一致性；3.关键指标（肌肉厚度（MT直、MT弯曲）、横截面积（CSA直、CSA弯曲）、微血管血流速度（MV直、MV弯曲）、弹性模量值（E直、E弯曲）八项指标）测量3次取均值。 数据处理流程：数据收集完成后，进行盲态审核，处理疑问数据。审核无误后锁定数据库，生成原始数据库和分析数据库。缺失数据处理采用多重插补法（如缺失率>5%）或完整案例分析（如缺失率<5%）。 数据保存：所有数据保存至试验终止后至少5年，由主要研究单位统一存档。

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

Data collection tools: Standardized case report form (CRF) was used to collect data. CRF was designed according to CDASH standard, including demographic information (sex, age, height, weight), multimodal ultrasound parameters (muscle thickness (MT straight, MT bending), cross-sectional area (CSA straight, CSA bending), microvascular blood flow velocity (MV straight, MV bending), elastic modulus (E straight, E bending), gold standard diagnostic indicators (ASMI, grip strength, 6m pace time, 5 sit-up test time measured by BIA). Data management:Electronic data acquisition system (such as REDCap) is used for data management. The implementation of two-person independent input, the system built-in logic verification program, the outliers and missing values are automatically questioned. All data modifications retain a complete audit track. Data quality control: 1. The ultrasound examination was performed independently by two trained doctors and remained blind to the results of the gold standard. Regular data monitoring to check the consistency of CRF data and original medical records; 3. The key indexes (muscle thickness (MT straight, MT bending), cross-sectional area (CSA straight, CSA bending), microvascular blood flow velocity (MV straight, MV bending), elastic modulus (E straight, E bending) were measured for 3 times. Data processing process: after the data collection is completed, conduct a blind audit to deal with the query data. Lock the database after verification and generate the original database and analysis database. The missing data are processed by multiple interpolation (such as missing rate > 5%) or complete case study (such as missing rate < 5%). Data preservation: all data shall be saved at least 5 years after the termination of the trial and shall be uniformly archived by the main research units.

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  2026-05-07 16:53:54