构建基于可解释性机器学习的运动处方智能系统:肿瘤心脏病学的运动预防与康复

注册号:

Registration number:

ChiCTR2300077887 

最近更新日期:

Date of Last Refreshed on:

2024-06-28 16:36:31 

注册时间:

Date of Registration:

2023-11-22 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

构建基于可解释性机器学习的运动处方智能系统:肿瘤心脏病学的运动预防与康复

Public title:

Development of an interpretable machine learning-based intelligent system of exercise prescription for cardio-oncology preventive care

注册题目简写:

English Acronym:

研究课题的正式科学名称:

构建基于机器学习模型的肿瘤心脏病学预防康复的运动处方系统

Scientific title:

Development of an interpretable machine learning-based intelligent system of exercise prescription for cardio-oncology preventive care

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:

高天宇 

研究负责人:

何珊 

Applicant:

Tianyu Gao 

Study leader:

Shan He 

申请注册联系人电话:

Applicant telephone:

+86 189 0300 9992

研究负责人电话:

Study leader's
telephone:

+86 136 6073 3639

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:

gaotianyu@jnu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

657367818@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黄埔大道西601号

研究负责人通讯地址:

中国广东省广州市天河区广州大道中1268号

Applicant address:

601 Huangpu Avenue West, Tianhe District, Guangzhou, Guangdong, China

Study leader's address:

1268 Guangzhou Avenue Middle, Tianhe District, Guangzhou, Guangdong, 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:

暨南大学

Applicant's institution:

School of PE, Jinan 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:

2023LCLL-41

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:

广州体育学院伦理委员会

Name of the ethic committee:

Ethics Committee of Guangzhou Sports University

伦理委员会批准日期:

Date of approved by ethic committee:

2023-07-13 00:00:00

伦理委员会联系人:

何珊

Contact Name of the ethic committee:

Shan He

伦理委员会联系地址:

中国广东省广州市天河区广州大道中1268号

Contact Address of the ethic committee:

1268 Guangzhou Avenue Middle, Tianhe District, Guangzhou, Guangdong, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 136 6073 3639

伦理委员会联系人邮箱:

Contact email of the ethic committee:

657367818@qq.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:

中国广东省广州市天河区广州大道中1268号

Primary sponsor's address:

1268 Guangzhou Avenue Middle, Tianhe District, Guangzhou, Guangdong, China

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):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州体育学院

具体地址:

中国广东省广州市天河区广州大道中1268号

Institution
hospital:

Guangzhou Sport University

Address:

1268 Guangzhou Avenue Middle, Tianhe District, Guangzhou, Guangdong, China

经费或物资来源:

个人课题

Source(s) of funding:

Personal Project

研究疾病:

肿瘤心脏病  

Target disease:

cardio-oncology

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:

单臂 

Study design:

Single arm 

研究目的:

开发一个可解释的基于机器学习的心脏肿瘤预防护理运动处方智能系统,并提出了研究方案。  

Objectives of Study:

To develop an interpretable machine learning-based intelligent system of exercise prescription for cardio-oncology preventive care, and this paper presents the study protocol.

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.当前或近期严重的运动损伤,则无资格入选; 2.存在严重CVD; 3.医生评估的其他不适合运动干预的情况。

Exclusion criteria:

1. Current or recent serious sports injuries; 2. Existing severe CVD; 3. Other conditions that may not be suitable for exercise interventions, as assessed by doctors.

研究实施时间:

Study execute time:

From 2023-01-01 00:00:00 To 2028-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2023-12-01 00:00:00 To 2026-12-31 00:00:00

干预措施:

Interventions:

组别:

试验组

样本量:

600

Group:

Test group

Sample size:

干预措施:

运动处方

干预措施代码:

Intervention:

Exercise Prescription

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

广东 

市(区县):

广州 

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州体育学院 

单位级别:

大学 

Institution
hospital:

Guangzhou Sport University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

24小时心电图

指标类型:

主要指标

Outcome:

24-Hour ECG

Type:

Primary indicator

测量时间点:

运动处方干预前和干预后

测量方法:

动态心电图监测设备

Measure time point of outcome:

Before and after exercise prescription

Measure method:

24-Hour ECG Equipment

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

不涉及

组织:

Sample Name:

NA

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 55 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):

不涉及随机方法。

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

Not Available.

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

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):

不适用

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

NA

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:

通过EHR系统进行数据管理。

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

Data collection and management through EHR system.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2023-11-22 17:25:49