乒乓球结合健步走运动对中老年人血管内皮功能及认知功能的影响

注册号:

Registration number:

ChiCTR2500103378 

最近更新日期:

Date of Last Refreshed on:

2025-05-28 15:14:21 

注册时间:

Date of Registration:

2025-05-28 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

乒乓球结合健步走运动对中老年人血管内皮功能及认知功能的影响

Public title:

Effect of table tennis combined with brisk walking exercise intervention on vascular endothelial function and cognitive function in middle-aged and elderly people

注册题目简写:

English Acronym:

研究课题的正式科学名称:

乒乓球结合健步走运动对中老年人血管内皮功能及认知功能的影响

Scientific title:

Effect of table tennis combined with brisk walking exercise intervention on vascular endothelial function and cognitive function in middle-aged and elderly people

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:

苏彩珠 

研究负责人:

高东东 

Applicant:

Caizhu Su 

Study leader:

Dongdong Gao 

申请注册联系人电话:

Applicant telephone:

+86 15880917265

研究负责人电话:

Study leader's
telephone:

+86 20 38025087

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:

846700420@qq.com

研究负责人电子邮件:

Study leader's E-mail:

909369261@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:

广东省广州市天河区林和街道广州大道中1268号

研究负责人通讯地址:

广东省广州市天河区广州大道中1268号

Applicant address:

No.1268,Guangzhou Avenue Middle,Tianhe District,Guangzhou, Guangdong

Study leader's address:

No.1268,Guangzhou Avenue Middle,Tianhe District,Guangzhou, Guangdong

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:

广州体育学院

Applicant's institution:

Guangzhou Sport University

研究负责人所在单位:

广州体育学院

Affiliation of the Leader:

Guangzhou Sport University

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:

2025LCLL-012

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:

广州体育学院伦理审查委员会

Name of the ethic committee:

Ethics Review Committee of Guangzhou Sport University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-02-28 00:00:00

伦理委员会联系人:

吕长生

Contact Name of the ethic committee:

Lv Changsheng

伦理委员会联系地址:

广东省广州市天河区广州大道中1268号

Contact Address of the ethic committee:

No.1268,Guangzhou Avenue Middle,Tianhe District,Guangzhou, Guangdong

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 20 38025032

伦理委员会联系人邮箱:

Contact email of the ethic committee:

15915765187@163.com

研究实施负责(组长)单位:

广州体育学院

Primary sponsor:

Guangzhou Sport University

研究实施负责(组长)单位地址:

广东省广州市天河区广州大道中1268号

Primary sponsor's address:

No.1268,Guangzhou Avenue Middle,Tianhe District,Guangzhou, Guangdong

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广州体育学院

具体地址:

广东省广州市天河区广州大道中1268号

Institution
hospital:

Guangzhou Sport University

Address:

No.1268,Guangzhou Avenue Middle,Tianhe District,Guangzhou, Guangdong

经费或物资来源:

自选课题(自筹)

Source(s) of funding:

Self-selected project (self-raised)

研究疾病:

心血管疾病  

Target disease:

Cardiovascular disease

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:

本研究主要采用认知行为测试、心血管测试和近红外脑电图等方法,分析被试运动干预前后的基本体能、行为、近红外和脑电数据,提取出反映被试任务表现的指标(如反应时间、准确性、脑区活动度、 等),并分析了中枢动脉和外周动脉的相关指标(如心率变异性、脉搏波传导速度、血流介导的血管舒张等),研究了乒乓球、快走和乒乓球联合快走对大学生认知功能和心血管功能的影响,并进一步探讨了其变化的神经生物学机制, 从而为研究运动改善脑功能和心血管功能的机制提供理论依据。  

Objectives of Study:

This study mainly used cognitive and behavioral test, cardiovascular test and near-infrared EEG to analyze the basic physical fitness, behavior, near-infrared and EEG data of the subjects before and after exercise intervention, and extracted the indicators that reflected the performance of the subjects' tasks (such as reaction time, accuracy, brain area activity, etc.), and analyzed the relevant indicators of the central artery and peripheral arteries (such as heart rate variability, pulse wave conduction velocity, blood flow-mediated vasodilation, etc.) to study table tennis, The effects of brisk walking and table tennis combined with brisk walking on the cognitive function and cardiovascular function of college students, and further explore the neurobiological mechanism of their changes, so as to provide a theoretical basis for the study of the mechanism of exercise to improve brain function and cardiovascular function.

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:

1.三个月内服用过抗生素,降压药物等;
2.体内有异物(手术钢钉等);
3.在实验周期因偶发不良事件或其他原因导致连续停止运动训练超过三次以上者。

Exclusion criteria:

1.Have taken antibiotics, antihypertensive drugs, etc. within three months;
2.There are foreign bodies in the body (surgical nails, etc.);
3.Those who have stopped exercise training for more than three consecutive times due to occasional adverse events or other reasons during the experimental cycle.

研究实施时间:

Study execute time:

From 2024-10-08 00:00:00 To 2025-01-19 00:00:00  

征募观察对象时间:

Recruiting time:

From 2024-10-27 00:00:00 To 2024-10-31 00:00:00

干预措施:

Interventions:

组别:

乒乓球结合健步走组

样本量:

12

Group:

Table tennis combined with brisk walking group

Sample size:

干预措施:

乒乓球结合健步走

干预措施代码:

Intervention:

Table tennis combined with brisk walking

Intervention code:

组别:

乒乓球组

样本量:

12

Group:

Table tennis group

Sample size:

干预措施:

乒乓球运动干预

干预措施代码:

Intervention:

Table tennis

Intervention code:

组别:

健步走组

样本量:

12

Group:

brisk walk group

Sample size:

干预措施:

健步走运动干预

干预措施代码:

Intervention:

Brisk walk

Intervention code:

组别:

对照组

样本量:

12

Group:

Control group

Sample size:

干预措施:

保持原有生活习惯

干预措施代码:

Intervention:

Maintain your habits

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

广东省 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

广州体育学院 

单位级别:

 

Institution
hospital:

Guangzhou Sport University

Level of the institution:

测量指标:

Outcomes:

指标中文名:

执行功能行为学

指标类型:

主要指标

Outcome:

Behavioral science of executive function

Type:

Primary indicator

测量时间点:

八周运动前后各测一次

测量方法:

通过使用Switching、Stroop、N-back三种任务范式对受试者的执行功能进行测试,测试程序用E-prime3.0软件编写,三组任务均采用组块设计。三组任务均收集反应时与正确率用于分析相对应的功能水平。

Measure time point of outcome:

It is measured before and after eight weeks of exercise

Measure method:

The subject's executive function was tested by using three task paradigms: Switching, Stroop and N-back, and the test program was written in E-prime3.0 software, and the three sets of tasks were designed in blocks. All three sets of tasks collect the level of function corresponding to the accuracy of the reaction and the analysis of the correct rate.

指标中文名:

血压

指标类型:

主要指标

Outcome:

Blood pressure

Type:

Primary indicator

测量时间点:

八周运动前后各测一次

测量方法:

采用澳大利亚 Boso 公司的 ABI-system 100 对所有受试者进行前后两次测试。测试前要求受试者静躺5分钟,全身呈“大”字形,测试时要求受试者保持正常呼吸,不可移动,不能谈话。将红、黄、黑、绿四个袖带分别绑在右臂、左臂、右踝、左踝处。

Measure time point of outcome:

It is measured before and after eight weeks of exercise

Measure method:

The ABI-system 100 from Boso in Australia was used to test all subjects twice before and after. Before the test, the subject was asked to lie still for 5 minutes, and the whole body was in a "big" shape, and the subject was required to maintain normal breathing during the test. Not moving, not talking. Tie the red, yellow, black, and green cuffs to the right arm, left arm, right ankle, and left ankle respectively.

指标中文名:

fNIRs功能性近红外光谱测试

指标类型:

主要指标

Outcome:

Functional NIR Spectroscopy, fNIRs

Type:

Primary indicator

测量时间点:

八周运动前后各测一次

测量方法:

本研究采用多通道NIR Sport便携式近红外成像系统实时监测执行功能任务期间前额叶含氧血红蛋白浓度信号的变化。

Measure time point of outcome:

It is measured before and after eight weeks of exercise

Measure method:

In this study, a multi-channel NIR Sport portable near-infrared imaging system was used to monitor the changes of oxygenated hemoglobin concentration signals in the prefrontal lobe during the performance of functional tasks in real time.

指标中文名:

体成分

指标类型:

主要指标

Outcome:

Body composition

Type:

Primary indicator

测量时间点:

八周运动前后各测一次

测量方法:

采用韩国Inbody370对所有受试者干预前后分别进行测试。测试时,身体不佩戴金属物品,双手大拇指握住两个电极,其余四指握紧把柄,抬头挺胸,双臂伸直展开,赤足静止站立于测试仪器上。

Measure time point of outcome:

It is measured before and after eight weeks of exercise

Measure method:

The Korean Inbody370 was used to test all subjects before and after the intervention. During the test, the body is not wearing metal objects, the thumbs of both hands hold the two electrodes, the other four fingers hold the handle, the head is raised and the chest is raised, the arms are stretched out, and the barefoot is standing still on the test instrument.

指标中文名:

血流介导的血管扩张功能

指标类型:

主要指标

Outcome:

FMD

Type:

Primary indicator

测量时间点:

八周运动前后各测一次

测量方法:

利用UNEXEF38G血管内皮功能检测仪进行血流介导的血管扩张功能(Flow Mediated Dilation, FMD )检测,进行干预前后的测试,。测量静息时肱动脉与驱血后肱动脉的直径,身体不能移动直到测试完成。

Measure time point of outcome:

It is measured before and after eight weeks of exercise

Measure method:

Flow-mediated vasodilation (FMD) testing was performed using a UNEXEF38G vascular endothelial function tester to perform pre- and post-intervention tests. The diameter of the brachial artery at rest versus the brachial artery after blood drive is measured, and the body cannot move until the test is completed.

指标中文名:

心率变异性

指标类型:

主要指标

Outcome:

HRV

Type:

Primary indicator

测量时间点:

八周运动前后各测一次

测量方法:

利用 SphygmoCor-Atcor Medical 进行干预前后的测试,按照仪器标识对应处贴电极片并进行5分钟的心电图记录。

Measure time point of outcome:

It is measured before and after eight weeks of exercise

Measure method:

SphygmoCor-Atcor Medical was used to perform pre- and post-intervention tests, and electrodes were attached to the corresponding parts of the instrument and electrocardiogram recording was performed for 5 minutes.

指标中文名:

脉搏波传导速度

指标类型:

主要指标

Outcome:

PWV

Type:

Primary indicator

测量时间点:

八周运动前后各测一次

测量方法:

利用 SphygmoCor-Atcor Medical 进行干预前后的测试。要求受试者平躺在诊疗床上,进行脉搏波传导速度测试,依次采集颈动脉与股动脉最强脉冲点的波形。

Measure time point of outcome:

It is measured before and after eight weeks of exercise

Measure method:

Pre- and post-intervention testing was performed with SphygmoCor-Atcor Medical. The subjects were asked to lie flat on the diagnosis and treatment bed, and the pulse wave conduction velocity test was carried out, and the waveforms of the strongest pulse points of the carotid artery and femoral artery were collected in turn.

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

由第三方实验者(不参与试验干预,且不参与采集和分析数据)进行动态随机化分组。

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

Dynamic randomization was performed by third-party experimenters (who did not participate in the trial intervention and did not participate in the collection and analysis of data).

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:

单盲,对评估者隐藏分组

Blinding:

Single blind study with blinded-evaluators

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):

原始数据将于研究发表五年后公开,于 https://ngdc.cncb.ac.cn/gsub/公布

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

The raw data will be made public five years after the study was published, in https://ngdc.cncb.ac.cn/gsub/

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:

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:

Electronic collection and management systems

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2025-05-28 15:14:16