ChiCTR2600117159 版本V1.0 版本创建时间2026/01/20 16:26:05 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:

ChiCTR2600117159 

最近更新日期:

Date of Last Refreshed on:

2026-01-20 16:25:51 

注册时间:

Date of Registration:

2026-01-20 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

基于多模态评估技术的健康人群运动训练动作矩阵生物力学机制与优化研究

Public title:

Research on the Biomechanical Mechanism and Optimization of Exercise Training Action Matrix for Healthy Population Based on Multimodal Evaluation Technology

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于多模态评估技术的健康人群运动训练动作矩阵生物力学机制与优化研究

Scientific title:

Research on the Biomechanical Mechanism and Optimization of Exercise Training Action Matrix for Healthy Population Based on Multimodal Evaluation Technology

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:

林紫玲 

研究负责人:

陈博 

Applicant:

Ziling Lin 

Study leader:

Bo Chen 

申请注册联系人电话:

Applicant telephone:

+86 180 5902 6679

研究负责人电话:

Study leader's
telephone:

+86 177 5021 6798

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:

2190910013@fjtcm.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

bochen_2023@126.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

福州市第二总医院

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:

福建省福州市仓山区上藤路47号

研究负责人通讯地址:

福建省福州市仓山区上藤路47号

Applicant address:

No. 47, Shangteng Road, Cangshan District, Fuzhou City, Fujian Province

Study leader's address:

No. 47, Shangteng Road, Cangshan District, Fuzhou City, Fujian Province

申请注册联系人邮政编码:

Applicant postcode:

350007

研究负责人邮政编码:

Study leader's postcode:

350007

申请人所在单位:

福州市第二总医院康复治疗部

Applicant's institution:

Rehabilitation Therapy Department of Fuzhou Second General Hospital

研究负责人所在单位:

福州市第二总医院

Affiliation of the Leader:

Fuzhou Second General Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2025398-1

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:

福州市第二总医院伦理委员会

Name of the ethic committee:

Ethics Committee of Fuzhou Second General Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2026-01-09 00:00:00

伦理委员会联系人:

刘岩

Contact Name of the ethic committee:

0591-22169317

伦理委员会联系地址:

福建省福州市仓山区上藤路47号

Contact Address of the ethic committee:

No. 47, Shangteng Road, Cangshan District, Fuzhou City, Fujian Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 591 2216 9317

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:

福州市第二总医院

Primary sponsor:

Fuzhou Second General Hospital

研究实施负责(组长)单位地址:

福建省福州市仓山区上藤路47号

Primary sponsor's address:

No. 47, Shangteng Road, Cangshan District, Fuzhou City, Fujian 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):

福建省

市(区县):

Country:

China

Province:

Fujian

City:

单位(医院):

福州市第二总医院

具体地址:

福建省福州市仓山区上藤路47号

Institution
hospital:

Fujian Second General Hospital

Address:

No. 47, Shangteng Road, Cangshan District, Fuzhou City, Fujian Province

经费或物资来源:

福州市第二总医院

Source(s) of funding:

Fujian Second General Hospital

研究疾病:

无  

Target disease:

none

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:

连续入组 

Study design:

Sequential 

研究目的:

(1)客观量化分析不同训练动作对核心肌群各个肌肉的激活强度、时序特征及形态学变化,明确各动作的肌肉激活差异性。 (2)构建针对 18-35岁青年人群的多维度肌力训练动作矩阵,为精准肌力训练提供标准化动作库。  

Objectives of Study:

(1) Objectively and quantitatively analyze the activation intensity, temporal characteristics and morphological changes of each muscle in the core muscle group caused by different training movements, and clarify the differences in muscle activation among each movement. (2) Build a multi-dimensional muscle strength training action matrix for young people aged 18 to 35 to provide a standardized action library for precise muscle strength training.

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. 18-35岁的健康人群; 2. 无肌肉骨骼系统疾病史(如骨折、关节脱位、肌腱损伤、关节炎等),近 6 个月无运动相关急性损伤(如肌肉拉伤、韧带扭伤); 3. 近 3 个月未规律参与专业运动训练; 4. 自愿签署知情同意书,能全程配合完成研究。

Inclusion criteria

1. Healthy individuals aged 18 to 35; 2. No history of musculoskeletal system diseases (such as fractures, joint dislocations, tendon injuries, arthritis, etc.), and no sports-related acute injuries (such as muscle strains, ligament sprains) in the past 6 months; 3. Has not regularly participated in professional sports training in the past three months; 4. Voluntarily sign the informed consent form and be able to cooperate throughout the research process.

排除标准:

1. 存在未愈合的肌肉骨骼损伤、慢性疼痛,或正在接受康复治疗、服用影响肌肉功能的药物; 2. 妊娠或哺乳期女性; 3. 精神障碍,有明显生理缺陷、重大疾病者及认知障碍者; 4. 存在神经系统疾病、心血管疾病、代谢性疾病等可能影响肌肉功能或运动能力的慢性疾病。

Exclusion criteria:

1. There is unhealed musculoskeletal injury, chronic pain, or currently undergoing rehabilitation treatment or taking drugs that affect muscle function; 2. Pregnant or lactating women; 3. Those with mental disorders, obvious physical defects, major diseases and cognitive impairments; 4. There are chronic diseases such as neurological disorders, cardiovascular diseases, and metabolic diseases that may affect muscle function or athletic ability.

研究实施时间:

Study execute time:

From 2026-01-04 00:00:00 To 2026-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-02-01 00:00:00 To 2026-12-31 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

86

Group:

Observation group

Sample size:

干预措施:

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):

福州 

市(区县):

福州 

Country:

China

Province:

Fujian

City:

单位(医院):

福州市第二总医院 

单位级别:

三甲 

Institution
hospital:

Fuzhou Second General Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

肌肉收缩活动值

指标类型:

主要指标

Outcome:

Muscle contraction activity value

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌肉厚度

指标类型:

主要指标

Outcome:

mucle thickness

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

足底压力值

指标类型:

主要指标

Outcome:

Foot sole pressure value

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核心稳定性功能指标

指标类型:

主要指标

Outcome:

Core stability function indicators

Type:

Primary 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:

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 years
最大 Max age 35 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):

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:

公开/Public

盲法:

Blinding:

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):

2026年12月1号通过ResMan提供原始数据查询 (www.medresman.org.cn)

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

Query the original data through ResMan on December 1, 2026 (www.medresman.org.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:

1. 病例记录表:每个入选自愿者都必须完成研究报告表,完成的原始研究报告表为申办单位所拥有,未经研究小组同意,不得以任何形式提供给第三者。 2. 数据库的建立:所有数据将采用计算机独立地进行双份录入,由软件自动核对并根据核对结果进行相应的修改。在此期间,将有疑问表通过临床监查员转交研究者进行数据审核,研究者应尽快回答并返回。随机抽10%的研究记录表人工检查一遍,考察是否存在数据出错。确认所建立的数据库正确后,由主要研究者、数据管理人员和统计分析人员对数据进行锁定。锁定后的数据文件不允许再作变动。 3. 资料保存:研究者应保存所有研究资料,包括对所有参加自愿者的确认(能有效地核对不同的记录资料)、所有原始的有签名的自愿者知情同意书、所有研究报告表、的详细记录等。

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

1. Case record Form: Each selected volunteer must complete the research report form. The original completed research report form is owned by the sponsoring organization and cannot be provided to any third party without the consent of the research team. 2. Establishment of database: All data will be entered independently by computer in two copies, automatically checked by the software and modified accordingly according to the check results. During this period, the question form will be forwarded to the investigator through the clinical monitor for data review, and the investigator should answer and return as soon as possible. Randomly take 10% of the study record sheet and check it manually to see if there are any data errors. After confirming that the established database is correct, the data is locked by the principal investigator, data manager, and statistical analyst. The locked data file cannot be changed again. 3. Data preservation: Researchers should keep all research data, including confirmation of all participants (can effectively check different records), all original signed consent of volunteers, all research report forms, detailed records, etc.

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:

 2026-01-20 16:25:51