ChiCTR2500100617 版本V1.0 版本创建时间2025/04/11 14:31:20 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：

ChiCTR2500100617 

最近更新日期：

Date of Last Refreshed on：

2025-04-11 14:30:25 

注册时间：

Date of Registration：

2025-04-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

高强度间歇训练与中等强度持续运动对肥胖女大学生糖脂代谢及炎性因子的影响

Public title：

The effects of high-intensity interval training and moderate to mild continuous exercise on glucose and lipid metabolism and inflammatory factors in obese female college students

注册题目简写：

English Acronym：

研究课题的正式科学名称：

高强度间歇训练与中等强度持续运动对肥胖女大学生糖脂代谢及炎性因子的影响

Scientific title：

The effects of high-intensity interval training and moderate to mild continuous exercise on glucose and lipid metabolism and inflammatory factors in obese female college students

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：

杨文礼 

研究负责人：

杨文礼 

Applicant：

Wenli Yang 

Study leader：

Wenli Yang 

申请注册联系人电话：

Applicant telephone：

+86 138 1442 6482

研究负责人电话：

Study leader's telephone：

+86 138 1442 6482

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：

cumtwly@126.com

研究负责人电子邮件：

Study leader's E-mail：

cumtwly@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：

江苏省徐州市大学路1号 中国矿业大学体育学院

研究负责人通讯地址：

江苏省徐州市大学路1号 中国矿业大学体育学院

Applicant address：

No.1 Daxue Road, Xuzhou City, Jiangsu Province, China University of Mining and Technology, School of Physical Education

Study leader's address：

No.1 Daxue Road, Xuzhou City, Jiangsu Province, China University of Mining and Technology, School of Physical Education

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：

中国矿业大学

Applicant's institution：

China University of Mining and Technology

研究负责人所在单位：

中国矿业大学

Affiliation of the Leader：

China University of Mining and Technology

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：

XZXY-LK-20231201-0209

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：

徐州市中心医院生物医学研究伦理审查委员会

Name of the ethic committee：

Xuzhou Central Hospital Biomedical Research Ethics Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2023-12-19 00:00:00

伦理委员会联系人：

蒋明伟

Contact Name of the ethic committee：

Mingwei Jiang

伦理委员会联系地址：

江苏省徐州市大龙湖街道太行路29号 徐州市中心医院新城区分院

Contact Address of the ethic committee：

Xuzhou Central Hospital, No. 29 Taihang Road, Dalonghu Street, Xuzhou City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 516 8395 6765

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：

中国矿业大学

Primary sponsor：

China University of Mining and Technology

研究实施负责（组长）单位地址：

江苏省徐州市大学路1号

Primary sponsor's address：

No.1 Daxue Road, Xuzhou City, Jiangsu 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)：

江苏

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

中国矿业大学

具体地址：

江苏省徐州市大学路路1号

Institution
hospital：

Xuzhou Central Hospital

Address：

No.1 Daxue Road, Xuzhou City, Jiangsu Province

经费或物资来源：

江苏省高教学会

Source(s) of funding：

Jiangsu Higher Education Association

Target disease：

Obesity

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：

本研究旨在对在校肥胖女大学生分别进行高强度间歇训练与 中等强度持续有氧运动干预，并比较两种不同运动方式对其身体形态、糖脂代谢、体内炎性因子及身体自尊的影响，为科学减肥提供实践依据。  

Objectives of Study：

This study aims to conduct high-intensity interval training (HIIT) and moderate-intensity continuous aerobic exercise interventions among obese female college students, respectively, and to compare the effects of these two different exercise modes on their body shape, glucose and lipid metabolism, inflammatory factors in the body, and body self-esteem, thereby providing practical evidence for scientific weight loss.

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.为在校女大学生，体重指数（body mass index， BMI）为28~32 kg·m-2，均符合中国成人女性肥胖体脂百分比≥25%的判定标准。 2.近3个月体重保持稳定，近 3 个月体重变化不超过±1.5kg 3.除参加体育课外，近半年无其他规律性、有组织的体育锻炼行为，平时无规律锻炼习惯。 4.无高血压、糖尿病等心血管、内分泌系统疾病。

Inclusion criteria

1.The participants were female college students with a body mass index (BMI) ranging from 28 to 32 kg·m^2, all fulfilling the criteria for obesity in Chinese adult females, which is defined as a body fat percentage >= 25%; 2.Their body weights had remained stable within the past three months,, the change in body weight in the past 3 months does not exceed +/-1.5kg; 3.In addition to participating in physical education classes, there is no other regular and organized physical exercise behavior in the past six months, and there is no regular exercise habit at ordinary times; 4. There are no cardiovascular and endocrine system diseases such as hypertension and diabetes.

排除标准：

1.排除高血压、糖尿病等心血管、内分泌系统疾病患者。 2.排除贫血、肝肾功能异常、甲状腺问题。 3.排除有运动禁忌症或影响运动参与的骨科问题。 4..无抽烟、喝酒等不良嗜好。

Exclusion criteria：

1.Patients with cardiovascular and endocrine system diseases such as hypertension and diabetes are excluded; 2.Excludes anemia, abnormal liver and kidney function, and thyroid problems; 3. Exclude orthopedic problems with contraindications to exercise or affecting exercise participation; 4. No bad habits such as smoking and drinking.

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2024-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-04-01 00:00:00 至 To 2024-07-01 00:00:00  

干预措施：

Interventions：

组别：

高强度间歇训练组

样本量：

16

Group：

The high-intensity interval training groop

Sample size：

干预措施：

高强度间歇训练组采用上海寰熙医疗器械有限公司生产的Puslar cosmos 4.0跑台训练系统，进行高强度间歇训练。在正式训练前均进行5 min、强度为50%最大摄氧量的准备活动，运动形式为功率自行车结合拉伸；在运动结束后进行5 min的有氧操拉伸整理活动。上述训练于每周一、周三、周五、周日下午各进行1次，每周训练4 d，连续干预12周。

干预措施代码：

Intervention：

The high-intensity interval training (HIIT) group utilized the Puslar cosmos 4.0 treadmill training system, produced by Shanghai Huanxi Medical Equipment Co., Ltd., to perform HIIT. Prior to the official training session, a 5-minute warm-up at 50% of the maximum oxygen uptake (VO2max) was conducted, incorporating cycling on a stationary bike combined with stretching exercises. Following the training, a 5-minute aerobic stretching and cool-down routine was performed. The aforementioned training sessions were conducted once each on Monday, Wednesday, Friday, and Sunday afternoons, totaling 4 days per week, for a continuous intervention period of 12 weeks.

Intervention code：

组别：

持续有氧训练组

样本量：

16

Group：

The continuous aerobic training group

Sample size：

干预措施：

持续有氧训练组采用上海寰熙医疗器械有限公司生产的Puslar cosmos 4.0跑台训练系统。在正式训练前均进行5 min、强度为50%最大摄氧量的准备活动，运动形式为功率自行车结合拉伸；训练方式为跑步，运动强度控制在60%VO2max水平，心率控制在135~140次/分钟，持续运动50 min，中间不休息。在运动结束后进行5 min的有氧操拉伸整理活动。上述训练于每周一、周三、周五、周日下午各进行1次，每周训练4 d，连续干预12周。

干预措施代码：

Intervention：

The continuous aerobic training group employed the Puslar cosmos 4.0 treadmill training system manufactured by Shanghai Huanxi Medical Equipment Co., Ltd. Prior to the official training session, a 5-minute warm-up at 50% of the maximum oxygen uptake (VO2max) was conducted, incorporating cycling on a stationary bike combined utilized with stretching exercises. The training consisted of running, with the exercise intensity maintained at 60% VO2max, and the heart rate kept within the range of 135 to 140 beats per minute, sustained for 50 minutes without any breaks. Following the training, a 5-minute aerobic stretching and cool-down routine was performed. The aforementioned training sessions were conducted once each on Monday, Wednesday, Friday, and Sunday afternoons, totaling 4 days per week, for a continuous intervention period of 12 weeks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China 

Province：

Xuzhou 

City：

 

单位(医院)：

徐州市中心医院 

单位级别：

三甲 

Institution
hospital：

Xuzhou Central Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

身高

指标类型：

主要指标

Outcome：

Height

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体重

指标类型：

主要指标

Outcome：

Weight

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

腰围

指标类型：

主要指标

Outcome：

Waist circumference

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

臀围

指标类型：

主要指标

Outcome：

Hip circumference

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：

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 18 岁 years
最大 Max age 23 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

由实验实施人员刘菁芃和高艳敏采用随机数字方法产生随机序列，对实验被试进行相应的实验分组。

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

The experimental participants were grouped into corresponding experimental groups by experimental implementers Jingpeng Liu and Yanmin Gao using random number methods 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：

None

Blinding：

None

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）：

日期：2024年12月16日，方式：（网络平台）http://www.medresman.org.cn/

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

Date: December 16, 2024, Method: (Online Platform) http://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：

一、填写纸质数据记录表（CRF） 1.基本信息填写： 使用中文填写CRF的名称、版本号等基本信息，并明确CRF的设计者、审核者以及使用者，确保信息的可追溯性和准确性。 2.内容要求： CRF详细记录每位受试者的相关信息，包括但不限于人口统计学资料、基线数据、干预措施、观察指标等。CRF中的每一项均认真填写。对于无记录的空格，应划横线表示，并对数据核对2遍，确保无误。如有数据更正，需采用划线并旁注修改数据的方式，同时由研究者签名并标注日期。 3.数据收集流程： 每一受试者观察疗程结束后，数据记录和采集人员在3个工作日内将报告表交主要研究者审核、签名。数据质疑采用实时逻辑质疑和手工质疑的方式，质疑报告需及时反馈给研究者和项目负责人。 二、电子数据采集和管理系统（EDC） 1.系统信息： 填写了EDC系统的名称、版本号以及系统类型等基本信息，并明确了EDC系统的设计者、审核者以及使用者，确保系统的安全性和合规性。 2.数据录入与核查： 数据管理员在数据录入前进行再次核查，确保数据的准确性和完整性。数据录入采用二次录入的方式，以避免录入错误。数据录入完成后，进行数据核查，包括完整性检查、逻辑一致性检查等。 3.数据管理与存储： EDC系统可提供数据备份和恢复功能，确保数据的安全性，并妥善保存原始，并按照相关规定进行了存档和备查。研究中本人已采取措施防止数据意外丢失或被提前销毁。

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

I. Completion of Paper-based Case Report Forms (CRFs) Basic Information Entry: The CRF's fundamental details, including its name, version number, and other pertinent information, should be filled in using Chinese, with clear identification of the CRF's designer, reviewer, and user, to ensure traceability and accuracy of the recorded information. Content Requirements: The CRF meticulously documents the relevant information of each subject, encompassing but not limited to demographic data, baseline metrics, intervention measures, and observational indicators. Each item in the CRF must be diligently filled out. Unfilled spaces should be indicated with a horizontal line, and data should undergo double-checking to ensure its accuracy. In cases of data corrections, the original data should be struck through with the revised value noted beside, accompanied by the researcher's signature and the date of the correction. Data Collection Process: Upon completion of the observation period for each subject, data recorders and collectors are required to submit the CRF to the principal investigator for review and signature within three working days. Data queries are conducted through both real-time logical checks and manual reviews, with query reports promptly communicated to researchers and project leaders. II. Electronic Data Capture and Management System (EDC) System Information: The EDC system's fundamental details, such as its name, version number, and system type, have been entered, along with clear identification of the system's designer, reviewer, and user, to ensure the system's security and compliance with relevant regulations. Data Entry and Verification: Prior to data entry, data administrators conduct a secondary verification process to ensure the accuracy and completeness of the data. Double entry is employed during data entry to minimize errors. Upon completion of data entry, verification procedures are performed, encompassing completeness checks, logical consistency assessments, and other relevant verifications. Data Management and Storage: The EDC system provides data backup and recovery functionalities to ensure data security. Original data is preserved securely, with archiving and documentation measures in place for future reference. Measures have been implemented by the researcher to prevent accidental data loss or premature destruction during the study.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-04-11 14:30:25