ChiCTR2500105494 版本V1.0 版本创建时间2025/07/04 09:55:15 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：

ChiCTR2500105494 

最近更新日期：

Date of Last Refreshed on：

2025-07-04 09:55:07 

注册时间：

Date of Registration：

2025-07-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

高强度间歇运动和中等强度持续有氧运动对心肌梗死患者血浆蛋白组学和代谢组学影响

Public title：

The Impact of High-Intensity Interval Training and Moderate-Intensity Continuous Training on Plasma Proteomics and Metabolomics in Myocardial Infarction Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

高强度间歇运动和中等强度持续有氧运动对心肌梗死患者血浆蛋白组学和代谢组学影响

Scientific title：

The Impact of High-Intensity Interval Training and Moderate-Intensity Continuous Training on Plasma Proteomics and Metabolomics in Myocardial Infarction Patients

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：

游柏阳 

研究负责人：

刘遂心 

Applicant：

You Baiyang 

Study leader：

Liu Suixin 

申请注册联系人电话：

Applicant telephone：

+86 152 0085 5735

研究负责人电话：

Study leader's telephone：

+86 136 1847 6706

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：

youbaiyang@csu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

liusuixin@csu.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：

湖南省长沙市开福区湘雅路87号

研究负责人通讯地址：

湖南省长沙市开福区湘雅路87号

Applicant address：

87 Xiangya Road, Kaifu District, Changsha, Hu'nan

Study leader's address：

87 Xiangya Road, Kaifu District, Changsha, Hu'nan

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：

中南大学湘雅医院

Applicant's institution：

Xiangya Hospital Central South University

研究负责人所在单位：

中南大学湘雅医院

Affiliation of the Leader：

Xiangya Hospital Central South 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：

伦审科简第(2025050729)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：

中南大学湘雅医院医学伦理审查委员会

Name of the ethic committee：

Medical Ethics Review Committee of Xiangya Hospital Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-05-13 00:00:00

伦理委员会联系人：

张欣

Contact Name of the ethic committee：

Zhang Xin

伦理委员会联系地址：

湖南省长沙市开福区湘雅路87号

Contact Address of the ethic committee：

87 Xiangya Road, Kaifu District, Changsha, Hu'nan

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 731 8432 7919

伦理委员会联系人邮箱：

Contact email of the ethic committee：

xyyyllwyh@126.com

研究实施负责（组长）单位：

中南大学湘雅医院

Primary sponsor：

Xiangya Hospital Central South University

研究实施负责（组长）单位地址：

湖南省长沙市开福区湘雅路87号

Primary sponsor's address：

87 Xiangya Road, Kaifu District, Changsha, Hu'nan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hu'nan

City：

Changsha

单位(医院)：

中南大学湘雅医院

具体地址：

开福区湘雅路87号

Institution
hospital：

Xiangya Hospital Central South University

Address：

87 Xiangya Road, Kaifu District

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China

Target disease：

Myocardial infarction

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

通过蛋白组学和代谢组学探究高强度间歇运动和中等强度持续运动引起的心肌梗死患者差异表达的血浆蛋白质和代谢分子。  

Objectives of Study：

To explore the differentially expressed plasma proteins and metabolic molecules in patients with myocardial infarction induced by high-intensity interval exercise and moderate-intensity continuous exercise through proteomics and metabolomics.

药物成份或治疗方案详述：

1. MICT的运动方案为：热身1min后以50%MRC的强度持续训练36 min，然后放松4min, 合计41分钟。 2. HIIT的运动方案为：热身后1min后，以70%MRC的强度进行4min高强度训练，之后以30%MRC进行4min低强度训练，高强度训练-低强度恢复如此循环，循环4次，然后放松4min，合计41分钟。 

Description for medicine or protocol of treatment in detail：

1. The exercise plan of MICT was: After 1min of warm-up, continuous training at 50%MRC intensity for 36 min, and then relaxing for 4min, a total of 41 minutes. 2. The exercise plan of HIIT was: 1min after warm-up, 4min of high-intensity training at 70%MRC intensity, then 4min of low-intensity training at 30%MRC, high-intensity training-low-intensity recovery cycle, cycle for 4 times, and then relax for 4min, 41 minutes in total. 

纳入标准：

1.年龄18-75周岁，性别不限； 2.既往有明确的心肌梗死病史，并接受血运重建（PCI或CABG），术后3个月以上； 3.久坐，是指每周运动时间小于3 h，同时每天静态活动时间8 h及以上界定为久坐人群；不满足以上条件界定为非久坐人群。其中静态活动时间指受试者每天上班时使用电脑、写材料、开会及下班后看电视、玩电脑、下棋、读书等时间总和；每周运动时间指受试者每周参加中等强度(稍感吃力)及以上健身锻炼的时间总和； 4.运动风险分层为低中危患者（具体危险分层方法参考冠心病患者的运动危险分层表）； 5.依从性良好，自愿参与研究，同意参与该研究并能签署书面知情同意书。

Inclusion criteria

1. Age range: 18 to 75 years old, gender not restricted; 2. A clear history of myocardial infarction and having undergone revascularization (PCI or CABG), with at least 3 months post-operation; 3. Sedentary was defined as those who exercised for less than 3 hours per week and spent 8 hours or more in static activities per day. Those who do not meet the above conditions are defined as non-sedentary people. The static activity time refers to the total time of subjects using a computer, writing materials at work, having meetings, watching TV, playing computer games, playing chess, and reading after work every day. Weekly exercise time refers to the total number of hours per week that subjects participate in moderate intensity (slightly strenuous) or above fitness exercises. 4. The patients with low to moderate risk were classified as such (the specific risk stratification method can be found in the Exercise Risk Stratification Table for Patients with Coronary Heart Disease); 5. The participants had good compliance, voluntarily participated in the study, agreed to take part in the research, and were able to sign the written informed consent form.

排除标准：

1. 患者处于心肌梗死不稳定期（心肌梗死2周以内）； 2. 心肌损伤标志物升高者（包括肌酸激酶同工酶或肌钙蛋白）； 3. 失代偿或急性心力衰竭，左室射血分数＜40%； 4. 低强度运动（＜5.0代谢当量）出现心绞痛，或静息性心绞痛； 5. 静息状态、运动中、运动终止后存在严重的心律失常（频发室性早搏、室性心动过速、心室扑动和颤动、室上性心动过速、快速性心房颤动、严重的心动过缓、II°II 型以上房室传导阻滞）； 6. 既往起搏器、ICD、CRT植入者； 7. 患有严重精神心理疾病； 8. 患有其他严重疾病（重症肺炎、脑出血或蛛网膜下腔出血、脑梗塞、严重肝功能和肾功能衰竭、严重贫血等）； 9 .合并限制运动测试和训练的严重疾病（如脑卒中后遗症、腰椎管狭窄、严重的退行性膝关节炎）； 10. 患有导致预期寿命不足1 年的疾病（如恶性肿瘤）； 11. 参加过系统的运动训练； 12. 近2周有节食和减重的行为； 13. 正在参加其他的临床试验；

Exclusion criteria：

1. The patient is in the unstable stage of myocardial infarction (within 2 weeks of myocardial infarction); 2. Those with elevated myocardial injury markers (including creatine kinase isoenzyme or troponin); 3. Decompensated or acute heart failure, with left ventricular ejection fraction < 40%; 4. Occurrence of angina pectoris during low-intensity exercise (< 5.0 metabolic equivalent), or resting angina pectoris; 5. Presence of severe arrhythmias at rest, during exercise, or after exercise termination (frequent premature ventricular contractions, ventricular tachycardia, ventricular flutter and fibrillation, supraventricular tachycardia, rapid atrial fibrillation, severe bradycardia, II°II or above atrioventricular conduction block); 6. Those who have had pacemaker, ICD, or CRT implantation previously; 7. Those with severe mental and psychological disorders; 8. Those with other serious diseases (severe pneumonia, cerebral hemorrhage or subarachnoid hemorrhage, cerebral infarction, severe liver and kidney failure, severe anemia, etc.); 9. Those with severe diseases that limit exercise testing and training (such as post-stroke sequelae, lumbar spinal stenosis, severe degenerative knee arthritis); 10. Those with diseases that result in an expected lifespan of less than 1 year (such as malignant tumors); 11. Those who have participated in systematic exercise training; 12. Those who have engaged in dieting and weight loss behaviors in the past 2 weeks; 13. Those who are currently participating in other clinical trials;

研究实施时间：

Study execute time：

从 From 2025-05-13 00:00:00至 To 2026-05-13 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-07-05 00:00:00 至 To 2026-05-13 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

5

Group：

Experimental group

Sample size：

干预措施：

先中等强度持续训练，后高强度间歇训练

干预措施代码：

Intervention：

Moderate-Intensity Continuous Training followed by high-Intensity Interval Training

Intervention code：

组别：

对照组

样本量：

5

Group：

Control group

Sample size：

干预措施：

先高强度间歇训练，后中等强度持续训练

干预措施代码：

Intervention：

High-Intensity Interval Training followed by Moderate-Intensity Continuous Training

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 长沙 

Country：

China 

Province：

Hu'nan 

City：

Changsha 

单位(医院)：

中南大学湘雅医院 

单位级别：

三甲 

Institution
hospital：

Xiangya Hospital Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

高强度间歇运动和中等强度持续有氧运动后差异表达的血浆蛋白

指标类型：

主要指标

Outcome：

High-intensity interval training (HIIT) and moderate-intensity continuous training (MICT)-induced differentially expressed proteins in adult plasma

Type：

Primary indicator

测量时间点：

用于蛋白组学检测的血浆样本将在高强度间歇运动和中等强度持续有氧运动前5分钟和后5分钟分别收集

测量方法：

蛋白质组学

Measure time point of outcome：

Plasma samples that will be used to detect proteome will be collected at 5 mins before and after each HIIT and MICT

Measure method：

Proteomics

指标中文名：

高强度间歇运动和中等强度持续有氧运动后差异表达的代谢分子

指标类型：

主要指标

Outcome：

High-intensity interval training (HIIT) and moderate-intensity continuous training (MICT)-induced differentially expressed metabolites in adult plasma

Type：

Primary indicator

测量时间点：

用于代谢组学检测的血浆样本将在高强度间歇运动和中等强度持续有氧运动前5分钟和后5分钟分别收集

测量方法：

代谢组学

Measure time point of outcome：

Plasma samples that will be used to detect metabolome will be collected at 5 mins before and after each HIIT and MICT

Measure method：

Metabolomics

指标中文名：

高强度间歇运动和中等强度持续有氧运动中心率反应

指标类型：

次要指标

Outcome：

Heart rate response to MICT and HIIT

Type：

Secondary indicator

测量时间点：

运动前、中、后

测量方法：

运动心肺负荷试验设备

Measure time point of outcome：

Before, during and after each HIIT and MICT sessions

Measure method：

Equipment for cardiopulmonary exercise testing

指标中文名：

高强度间歇运动和中等强度持续有氧运动中血压反应

指标类型：

次要指标

Outcome：

Systolic and diastolic blood pressure response to MICT and HIIT

Type：

Secondary indicator

测量时间点：

运动前、中、后

测量方法：

血压计手动测量血压

Measure time point of outcome：

Before, during and after each HIIT and MICT sessions

Measure method：

Manually measure blood pressure with sphygmomanometer

指标中文名：

高强度间歇运动和中等强度持续有氧运动中主观劳累评分

指标类型：

次要指标

Outcome：

Rating of perceived exertion during MICT and HIIT

Type：

Secondary indicator

测量时间点：

运动前、中、后

测量方法：

Borg主观劳累量表和呼吸困难量表

Measure time point of outcome：

Before, during and after each HIIT and MICT sessions

Measure method：

Borg Rating of Perceived Exertion Scale and Dyspnea Scale

指标中文名：

高强度间歇运动和中等强度持续有氧运动中气体交换指标

指标类型：

次要指标

Outcome：

Parameters of ventilatory and gas exchange dynamics during MICT and HIIT

Type：

Secondary indicator

测量时间点：

运动前、中、后

测量方法：

运动心肺负荷试验设备

Measure time point of outcome：

Before, during and after each HIIT and MICT sessions

Measure method：

Equipment for cardiopulmonary exercise testing

指标中文名：

人口学信息

指标类型：

附加指标

Outcome：

Demographics

Type：

Additional indicator

测量时间点：

入组时

测量方法：

问卷

Measure time point of outcome：

During enrollment

Measure method：

Questionnaires

指标中文名：

心肺运动负荷试验指标

指标类型：

附加指标

Outcome：

Parameters of cardiopulmonary exercise testing

Type：

Additional indicator

测量时间点：

正式运动前的安全性评估

测量方法：

运动心肺负荷试验设备

Measure time point of outcome：

Safety assessment before MICT and HIIT

Measure method：

Equipment for cardiopulmonary exercise testing

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

1）将符合所有纳入标准并不符合任何排除标准的受试者按纳入，进行编号；2）获取随机数字：由不参与干预的人员通过SPSS 26软件按顺序获取10个随机数字；3）将受试者按次序编号，并与获取的随机数字匹配；4）根据匹配结果分组（匹配方法是：将10个随机数字从小到大进行排序，得序号R，规定R1–R5为先MICT，后HIIT组；R6–R10为先HIIT，后MICT组），并将分组信息放入信封；5）每纳入一名受试者依次序给予对应的包含分组信息的信封,根据事先确定的分组方案，直接进入对应的分组开始试验。上述分组操作由不参与干预的人员进行。

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

1) Number the subjects who meet all the inclusion criteria and do not meet any exclusion criteria as "included"; 2) Obtain random numbers: 10 random numbers are sequentially obtained by non-intervention personnel using SPSS 26 software; 3) Number the subjects in sequence and match them with the obtained random numbers; 4) Group the subjects based on the matching results (the matching method is: sort the 10 random numbers from smallest to largest to obtain sequence number R. R1-R5 are the MICT group first and HIIT group second; R6-R10 are the HIIT group first and MICT group second), and put the grouping information into an envelope; 5) Give the corresponding envelope containing the grouping information to each subject in sequence when a subject is included. According to the pre-determined grouping scheme, directly enter the corresponding group to start the trial. The above grouping operation is carried out by non-intervention personnel.

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：

盲法：因为运动干预的特殊性，干预者和受试者均无法实现盲法。数据收集和分析者实行盲法。

Blinding：

Blinding: Due to the nature of exercise intervention, blinding cannot be achieved for the intervention personnel and participants. However, blinding is implemented for the person who will perform data collection and 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

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）：

（1）蛋白质组学数据将共享至Uniprot Knowledgebase，网址为https://www.uniprot.org。（2）代谢组学数据将共享至Human Metabolome Database, 网址为https://hmdb.ca。

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

(1) Proteomic data will be made public on the UniProt Knowledgebase website (https://www.uniprot.org).(2) Metabolomic data will be shared on the Human Metabolome Database website (https://hmdb.ca).

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：

将同时使用病例记录表和电子采集和管理系统。

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

Both CRF and Electronic Data Capture will be used for the collection and management of data.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-07-04 09:55:07