中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500102976
最近更新日期： Date of Last Refreshed on：	2025-05-22 11:40:39
注册时间： Date of Registration：	2025-05-22 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	不同强度运动训练对认知状态的影响
Public title：	The Impact of Different Intensity Exercise Training on Cognitive State
注册题目简写：
English Acronym：
研究课题的正式科学名称：	不同强度运动训练对认知状态的影响
Scientific title：	The Impact of Different Intensity Exercise Training on Cognitive State
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：	刘雅	研究负责人：	王建平
Applicant：	Ya Liu	Study leader：	Jianping Wang
申请注册联系人电话： Applicant telephone：	+86 155 8081 5436	研究负责人电话： Study leader's telephone：	+86 139 7478 8927
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：	359223031@qq.com	研究负责人电子邮件： Study leader's E-mail：	Wangjpppp@126.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：	湖南省长沙市开福区湘雅路87号	研究负责人通讯地址：	湖南省衡阳市蒸湘区解放大道35号
Applicant address：	No.87, Xiangya Road, Kaifu District, Changsha City, Hunan Province	Study leader's address：	35 Jiefang Avenue, Zhengxiang District, Hengyang, Hunan Province, China
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 of central south university
研究负责人所在单位：	南华大学第二附属医院
Affiliation of the Leader：	The Second Affiliated Hospital of Nanhua 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：	伦审临[2025]020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：	南华大学附属第二医院临床研究伦理审查委员会
Name of the ethic committee：	Ethics Committee of Clinical Research, The Second Affiliated Hospital of University of South China
伦理委员会批准日期： Date of approved by ethic committee：	2025-05-16 00:00:00
伦理委员会联系人：	袁娜
Contact Name of the ethic committee：	Na Yuan
伦理委员会联系地址：	湖南省衡阳市蒸湘区解放大道35号
Contact Address of the ethic committee：	35 Jiefang Avenue, Zhengxiang District, Hengyang, Hunan Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 187 7347 0768	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：

南华大学附属第二医院

Primary sponsor：

The Second Affiliated Hospital of University of South China

研究实施负责（组长）单位地址：

湖南省衡阳市蒸湘区解放大道35号

Primary sponsor's address：

35 Jiefang Avenue, Zhengxiang District, Hengyang, Hunan Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中华人民共和国	省(直辖市)：	湖南省	市(区县)：	衡阳
Country：	China	Province：	Hunan Province	City：	Hengyang
单位(医院)：	南华大学附属第二医院	具体地址：	湖南省衡阳市蒸湘区解放大道35号
Institution hospital：	The Second Affiliated Hospital of University of South China	Address：	35 Jiefang Avenue, Zhengxiang District, Hengyang, Hunan Province, China

经费或物资来源：

湖南省肥胖相关性疾病临床医学研究中心

Source(s) of funding：

Hunan obesity related disease clinical medical research center

研究疾病：

认知障碍

Target disease：

Cognition impariment

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：

1.主要目的本研究旨在通过随机对照实验，探究不同强度运动训练（包括低强度和高强度训练）对健康人群认知状态的影响，重点关注高强度运动是否可能引发认知功能下降等负面效应，并分析其潜在生理机制（如BDNF水平、炎症因子变化及脑血流调节）。研究结果将为制定科学合理的运动干预方案提供理论依据，同时为预防和延缓认知衰退提供实践指导。 2次要目的通过比较短期与长期运动干预对认知功能的影响差异，为健康人群制定科学合理的运动干预方案提供理论依据，以优化认知功能并预防认知衰退。

Objectives of Study：

1.Main purpose This study aims to explore the effects of different intensity exercise training (including low-intensity and high-intensity training) on the cognitive status of healthy people through a randomized controlled experiment, focusing on whether high-intensity exercise may cause negative effects such as cognitive decline, and analyzing its underlying physiological mechanisms (such as BDNF levels, inflammatory factor changes and cerebral blood flow regulation). The research results will provide a theoretical basis for formulating a scientific and reasonable exercise intervention program, and provide practical guidance for preventing and delaying cognitive decline. 2.Secondary purpose By comparing the effects of short-term and long-term exercise intervention on cognitive function, this paper provides a theoretical basis for healthy people to formulate a scientific and reasonable exercise intervention program, in order to optimize cognitive function and prevent cognitive decline.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

如满足以下标准中的任意一条，受试者不能入组本干预性研究： (1)入组前3个月内参与过任何干预性临床研究（包括药物/器械/生物制剂试验）； (2)重大系统性疾病史（需满足当前仍存在临床意义），详情如下: 循环系统疾病（如冠心病、高血压Ⅱ级以上、严重心律失常）；代谢内分泌疾病（糖尿病、甲状腺功能亢进/减退症等；泌尿系统疾病（慢性肾脏病3期及以上）；神经系统疾病（癫痫、卒中后遗症等）；免疫系统异常（原发性/获得性免疫缺陷、自身免疫性疾病）；其他系统性疾病（血液系统、呼吸系统、精神类疾病等）； (3)已诊断为痴呆或在MMSE中得分< 24分； (4)肾功能限制要求(血清肌酐需采用标准化检测方法)：肌酐清除率＜80 mL/min者｛肌酐清除率计算Cockcroft-Gault公式：CrCl=[(140-年龄)×体重(kg)]/[0.814×Scr(µmol/L)]｝； (5)临床检查异常, 入选时存在以下任何临床显著异常（研究者判定）：体格检查异常体征、ECG病理性改变、实验室检测值超出正常范围20%以上、超声/放射影像学显著异常、生命体征持续偏离基线值； (6)其他不宜入选情形:经研究团队综合评估存在影响研究完整性或受试者安全的特殊情形。 (7)伴急性脑卒中、颅脑肿瘤、阿尔兹海默症等神经性退行病疾病引起的认知功能障碍、视力障碍、听力及语言理解能力下降的疾病； (8)抑郁、焦虑等精神障碍病史； (9)因认知功能障碍或语言障碍而无法交流，或存在其他视听和语言交流障碍者，或存在因教育程度低，不具有具有阅读和书写能力而影响认知功能测评者。 (10)不能耐受静脉穿剌或有晕血、晕针史者； (11)明显出/凝血功能障碍者； (12)试验前3个月内献血者或大量失血者（＞400 mL）； (13)有运动系统疾病，如骨关节炎、骨折，无法完成运动任务者，或其他系统疾病但影响认知和运动功能者； (14)试验前3个月内接受过外科手术；或计划在研究期间进行外科手术者； (15)酗酒者或试验前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒）；或试验期间不愿意停止饮酒或使用任何含酒精的制品者；或酒精呼气测试结果阳性（＞0.0 mg/100 mL）； (16)体内存在心脏起搏器、人工耳蜗、钢钉、钢板，或患有幽闭恐惧症，不适宜做磁共振检查的患者。 (17)试验前30天内使用过任何药物者； (18)经研究者判定不能入组者； (19)非自愿参加且未签署知情同意书者。

Exclusion criteria：

If any of the following criteria is met, the subject cannot be enrolled in the intervention study: 1. Participated in any intervention clinical research (including drug / device / biological agent test) within 3 months before enrollment; 2. History of major systemic diseases (to meet the current clinical significance), details are as follows: Diseases of circulatory system (such as coronary heart disease, hypertension above grade II, severe arrhythmia); Metabolic and endocrine diseases (diabetes, hyperthyroidism / hypothyroidism, etc.); urinary system diseases (chronic kidney disease stage 3 and above); Neurological diseases (epilepsy, stroke sequelae, etc.); Immune system abnormalities (primary / acquired immunodeficiency, autoimmune diseases); Other systemic diseases (blood system, respiratory system, psychiatric diseases, etc.); 3. Diagnosed with dementia or scored < 24 on the MMSE; 4. Renal function restriction requirements (standardized detection method shall be adopted for serum creatinine): for those with creatinine clearance less than 80 ml/min {Cockcroft Gault formula for creatinine clearance calculation: crcl=[(140 age) × body weight (kg)] / [0.814 × SCR (µ mol/l)]; 5.The clinical examination was abnormal, and there were any of the following clinically significant abnormalities (judged by the investigator) at the time of enrollment: abnormal physical examination signs, ECG pathological changes, laboratory test values exceeding the normal range by more than 20%, significant abnormalities in ultrasound / radiological imaging, and continuous deviation of vital signs from the baseline value; 6. Other circumstances not suitable for selection: there are special circumstances that affect the integrity of the study or the safety of subjects according to the comprehensive assessment of the research team. The 7.Diseases with cognitive dysfunction, visual impairment, hearing and language comprehension decline caused by acute stroke, brain tumor, Alzheimer's disease and other neurodegenerative diseases; 8.History of depression, anxiety and other mental disorders; 9.Those who are unable to communicate due to cognitive dysfunction or language impairment, or have other audio-visual and language communication disorders, or have low education and do not have the ability to read and write, which affects the assessment of cognitive function. 10.Those who cannot tolerate venous puncture or have a history of blood and needle syncope; 11.Obvious bleeding / coagulation dysfunction; The 12.Blood donors or massive blood loss (> 400 ml) within 3 months before the test; 13.Those with motor system diseases, such as osteoarthritis and fracture, who are unable to complete motor tasks, or those with other system diseases that affect cognition and motor function; 14.Had undergone surgery within 3 months before the trial; Or planned surgical procedures during the study period; 15.Alcoholics or regular drinkers within 6 months before the test, i.e. drinking more than 14 units of alcohol per week (1 unit =360 ml beer or 45 ml spirits with 40% alcohol or 150 ml wine); Or unwilling to stop drinking alcohol or use any alcohol containing products during the test; Or positive alcohol breath test result (> 0.0 mg/100 ml); 16.Patients with cardiac pacemakers, cochlear implants, steel nails, steel plates, or claustrophobia who are not suitable for magnetic resonance examination. 17.Those who have used any drug within 30 days before the test; The 18.Those who cannot be enrolled after being judged by the researcher; 19.Those who do not voluntarily participate and do not sign the informed consent.

研究实施时间：

Study execute time：

从 From 2025-06-06 00:00:00至 To 2025-09-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-06-06 00:00:00 至 To 2025-07-31 00:00:00

干预措施：

Interventions：

组别：	无运动习惯进行适量运动组	样本量：	20
Group：	Moderate exercise group without exercise habits	Sample size：	20
干预措施：	该组受试对象为入组前没有运动训练习惯的人群。根据个体VO2max水平进行每周运动方案设计，在受试期间，以平均心率不低于70% VO2max对应的心率进行运动，安排5次训练阶段，以达到每周训练MET总值不低于1000，达到目标值后不再进行运动训练。	干预措施代码：
Intervention：	The subjects in this group were those who had no exercise training habits before enrollment. According to the individual VO2max level, the weekly exercise program is designed. During the test period, exercise with the heart rate corresponding to the average heart rate of no less than 70% VO2max. Five training phases are arranged to achieve a total met value of no less than 1000 per week. After reaching the target value, no exercise training is carried out.	Intervention code：

组别：	有运动习惯保持适量运动组	样本量：	20
Group：	Have exercise habits and maintain moderate exercise group	Sample size：	20
干预措施：	该组受试对象为入组前有运动习惯的人群，通过问卷调查显示每周高强度运动MET总值于800-1200。根据个体VO2max水平进行每周运动方案设计，在受试期间，以平均心率不低于70% VO2max对应的心率进行运动，安排5次训练阶段，以达到每周训练MET总值不低于1000，达到目标值后不再进行运动训练。	干预措施代码：
Intervention：	The subjects of this group were the people who had exercise habits before enrollment. According to the questionnaire survey, the total met value of weekly high-intensity exercise was 800-1200. According to the individual VO2max level, the weekly exercise program is designed. During the test period, exercise with the heart rate corresponding to the average heart rate of no less than 70% VO2max. Five training phases are arranged to achieve a total met value of no less than 1000 per week. After reaching the target value, no exercise training is carried out.	Intervention code：

组别：	有运动习惯进行阶梯上升运动组	样本量：	20
Group：	Group with exercise habit and step up exercise	Sample size：	20
干预措施：	该组受试对象为入组前有运动习惯的人群，通过问卷调查显示每周高强度运动MET总值于800-1200。根据个体VO2max水平进行每周运动方案设计，在受试期间，以平均心率不低于70% VO2max对应的心率进行运动，每周安排5次训练阶段，第一周训练MET目标值为1000，随后每周训练的MET目标值增加500。	干预措施代码：
Intervention：	The subjects of this group were the people who had exercise habits before enrollment. According to the questionnaire survey, the total met value of weekly high-intensity exercise was 800-1200. The weekly exercise plan was designed according to the individual VO2max level. During the test period, exercise with the heart rate corresponding to the average heart rate of no less than 70% VO2max. Five training phases were arranged every week. The met target value of the first week of training was 1000, and then the met target value of the next week of training increased by 500.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	湖南省	市(区县)：	衡阳市
Country：	China	Province：	Hunan Province	City：	Hengyang
单位(医院)：	南华大学附属第二医院	单位级别：	三甲
Institution hospital：	The Second Affiliated Hospital of University of South China	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	流体智力	指标类型：	主要指标
Outcome：	Fluid Intelligence	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	数字记忆评分	指标类型：	主要指标
Outcome：	Numeric Memory score	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	认知功能	指标类型：	主要指标
Outcome：	Cognitive function	Type：	Primary indicator
测量时间点：		测量方法：	海马多体素检测MRS
Measure time point of outcome：		Measure method：	Magnetic Resonance Spectroscopy

指标中文名：	心肺运动	指标类型：	主要指标
Outcome：	Cardiopulmonary exercise	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	实验室检测指标	指标类型：	次要指标
Outcome：	Laboratory test 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：	人体测量学指标	指标类型：	附加指标
Outcome：	Anthropometric index	Type：	Additional 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	使用后保存	说明
Fate of sample：	Preservation 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	40	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）：

采用SAS 9.4软件生成随机序列

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

SAS 9.4 software was used to generate random sequences.

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：	受试者不知道分组
Blinding：	Subjects are not aware of the grouping.

是否共享原始数据： IPD sharing	否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：	本研究由研究者采用CRF表进行临床研究数据的采集，并转化为电子信息管理，采用受试者日记卡进行访视间期患者安全性数据的采集和管理。原始病历和记录作为临床试验的原始文件应完整保存。原始病历和记录由研究者负责填写和保管，每次填写前应先核对病历封面的受试者信息，字迹工整易于辨认，便于与 CRF 进行数据核对。 CRF中的数据来自于原始病历和记录、实验室检查报告单等原始文件并应与原始文件保持一致。试验中的任何观察、检查结果均应及时、正确、完整、规范、真实地的填写于CRF 中。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	In this study, the researcher used CRF table to collect the clinical research data, and transformed it into electronic information management. The subject diary card was used to collect and manage the safety data of patients during the visit interval. The The original medical records and records as the original documents of clinical trials should be kept completely. The investigator is responsible for filling in and keeping the original medical records and records. Before filling in each time, the subject information on the cover of the medical records should be checked. The handwriting is neat and easy to identify, which is convenient for data verification with CRF. The The data in CRF comes from the original medical records, laboratory test reports and other original documents and should be consistent with the original documents. Any observation and inspection results during the test shall be timely, correctly, completely, canonically and truthfully filled in the CRF.
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：	2025-05-22 11:40:29