ChiCTR2400093952 版本V1.0 版本创建时间2024/12/13 17:27:20 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：

ChiCTR2400093952 

最近更新日期：

Date of Last Refreshed on：

2024-12-13 17:26:56 

注册时间：

Date of Registration：

2024-12-13 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

HIIT联合RT对超重肥胖大学生心脏代谢健康的干预研究

Public title：

The intervention study of HIIT combined with RT on Heart Metabolic Health in overweight and obese college students.

注册题目简写：

HIIT+RT对超重肥胖大学生心脏代谢健康的干预研究

English Acronym：

HIIT + RT Intervention for Heart Metabolic Health in Overweight and Obese College Students

研究课题的正式科学名称：

HIIT联合RT对超重肥胖大学生心脏代谢健康的干预研究

Scientific title：

The intervention study of HIIT combined with RT on Heart Metabolic Health in overweight and obese 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：

赵苏冰 

研究负责人：

赵苏冰/ 李宝国 

Applicant：

Zhao Subing 

Study leader：

Zhao Subing/ Li Baoguo 

申请注册联系人电话：

Applicant telephone：

+86 166 0563 4231

研究负责人电话：

Study leader's telephone：

+86 135 6555 2927

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：

2763588153@qq.com

研究负责人电子邮件：

Study leader's E-mail：

85127901@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://www.shzu.edu.cn/

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

https://www.shzu.edu.cn/

申请注册联系人通讯地址：

新疆维吾尔自治区石河子市石河子大学体育学院

研究负责人通讯地址：

新疆维吾尔自治区石河子市石河子大学体育学院

Applicant address：

School of Physical Education, Shihezi University, Shihezi City, Xinjiang Uygur Autonomous Region, China

Study leader's address：

School of Physical Education, Shihezi University, Shihezi City, Xinjiang Uygur Autonomous Region, China

申请注册联系人邮政编码：

Applicant postcode：

832003

研究负责人邮政编码：

Study leader's postcode：

832003

申请人所在单位：

石河子大学体育学院

Applicant's institution：

School of Physical Education, Shihezi University

研究负责人所在单位：

石河子大学体育学院

Affiliation of the Leader：

School of Physical Education, Shihezi 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：

KJ2024-407-02

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：

石河子大学第一附属医院科技伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Shihezi University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-10-29 00:00:00

伦理委员会联系人：

闫素

Contact Name of the ethic committee：

Yan Su

伦理委员会联系地址：

新疆维吾尔自治区石河子市石河子大学第一附属医院科研科

Contact Address of the ethic committee：

Department of Scientific Research, First Affiliated Hospital of Shihezi University, Shihezi City, Xinjiang Uygur Autonomous Region, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 993 201 6530

伦理委员会联系人邮箱：

Contact email of the ethic committee：

irb0993@163.com

研究实施负责（组长）单位：

石河子大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Shihezi University

研究实施负责（组长）单位地址：

新疆维吾尔自治区石河子市北二路石河子大学第一附属医院

Primary sponsor's address：

The First Affiliated Hospital of Shihezi University, North 2nd Road, Shihezi City, Xinjiang Uygur Autonomous Region, 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)：

新疆维吾尔自治区

市(区县)：

石河子

Country：

China

Province：

Xinjiang Uygur Autonomous Region

City：

Shihezi

单位(医院)：

石河子大学体育学院

具体地址：

新疆维吾尔自治区石河子市石河子大学体育学院

Institution
hospital：

School of Physical Education, Shihezi University

Address：

School of Physical Education, Shihezi University, Shihezi City, Xinjiang Uygur Autonomous Region, China

经费或物资来源：

研究者自筹

Source(s) of funding：

Self-funded by the researcher

Target disease：

Overweight, Obesity

Target disease code：

E66

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：

本研究旨在探索8周的HIIT联合RT对超重肥胖大学生心脏代谢健康的影响，着重评估心血管功能、血脂水平、糖代谢和体成分等心脏代谢健康指标的变化。  

Objectives of Study：

This study aims to explore the effects of an 8-week HIIT combined with RT program on the cardiometabolic health of overweight and obese college students, with a focus on evaluating changes in cardiometabolic health indicators such as cardiovascular function, blood lipid levels, glucose metabolism, and body composition.

药物成份或治疗方案详述：

运动方案：进行为期8周的HIIT联合RT对超重肥胖大学生心脏代谢健康的作用。 试验1组（HIIT组）：该组使用风阻车进行间歇训练，交替进行高强度与低强度恢复训练。3次/周。每次高强度间歇训练循环8-10次，每次循环含高强度训练时间持续10-15秒，低强度恢复时间持续10-15秒。高强度训练时心率不低于最大心率的80-85%。每次训练内容含热身5分钟，高强度间歇训练，整理活动10分钟。高强度间歇训练总循环24-30次/周。进阶遵循个体化、适应性、渐进性、系统性、可重复性、依从性原则。 试验2组（RT组）：自重循环训练法，3次/周，每次抗阻训练循环4-6次，每次循环每个动作10-15次重复，以自重形式为主。每次含热身5分钟，抗阻训练，整理活动10分钟。抗阻训练总循环12-18次/周。进阶同HIIT组。 试验3组（HIIT+RT组）：每次训练联合HIIT与RT训练，其训练频率、强度、时间、运动方式、总量、进阶同HIIT组和RT组，以优化心肺功能和肌肉力量的综合提升。 试验4组（碎片化运动组）：五层楼梯全力冲刺训练，频率为3次/日，3日/周，每次训练强度不低于最大心率的80%，每次训练时间不超过30秒，两次训练间歇时间不低于1小时。 备注：整个干预过程将配备专门的监督人员，每次训练约30分钟，所有受试者训练过程当中全程佩戴心率带（FIRSTBEAT）并使用FristBeat SPORTS software 监控，确保受试者的心率及运动强度（最大摄氧量强度）在安全范围内进行运动。确保训练安全，并提供必要的急救设备，以保障受试者的健康和实验的顺利进行。 

Description for medicine or protocol of treatment in detail：

Exercise Protocol: An 8-week HIIT combined with RT program to study its effects on the cardiometabolic health of overweight and obese college students. Group 1 (HIIT Group): This group performs interval training on an air-resistance bike, alternating between high-intensity and low-intensity recovery. Training is conducted 3 times per week. Each high-intensity interval training session consists of 8-10 cycles, with each cycle including 10-15 seconds of high-intensity training and 10-15 seconds of low-intensity recovery. Heart rate during high-intensity intervals is maintained at 80-85% of the maximum heart rate. Each session includes a 5-minute warm-up, high-intensity interval training, and a 10-minute cool-down. Weekly total high-intensity interval training cycles range from 24-30. Progression follows the principles of individualization, adaptability, gradual improvement, systematic planning, repeatability, and compliance. Group 2 (RT Group): This group performs bodyweight circuit training 3 times per week. Each resistance training session consists of 4-6 cycles, with each cycle including 10-15 repetitions of each exercise, primarily using bodyweight. Each session includes a 5-minute warm-up, resistance training, and a 10-minute cool-down. Weekly total resistance training cycles range from 12-18. Progression follows the same principles as the HIIT group. Group 3 (HIIT+RT Group): Each session in this group combines HIIT and RT training. The frequency, intensity, duration, exercise mode, total volume, and progression follow the protocols of the HIIT and RT groups to optimize comprehensive improvements in cardiorespiratory function and muscle strength. Group 4 (Fragmented Exercise Group): This group performs maximum-effort sprint training up a five-story staircase. The frequency is 3 sessions per day, 3 days per week. Each training session involves sprints with a heart rate of no less than 80% of the maximum heart rate. The duration of each session does not exceed 30 seconds, with a rest interval of at least 1 hour between sessions. Notes: The entire intervention process will be supervised by designated personnel. Each training session lasts approximately 30 minutes. All participants will wear heart rate monitors (FIRSTBEAT) throughout the training process, and training intensity (maximal oxygen uptake) will be monitored using FirstBeat SPORTS software to ensure safe exercise intensity and heart rate levels. Safety measures will be implemented, and necessary emergency equipment will be provided to ensure the participants' health and the smooth execution of the study.  

纳入标准：

受试者为石河子大学 18 至 30 岁的全日制在校大学生，男女不限；受试者的 BMI需在 25 至 40 之间，符合超重和肥胖标准。男性腰围≥90 cm，女性腰围≥85 cm，WHR 男性≥0.9，女性≥0.85，且 BRI 在 4.0 至 14.0 之间；受试者需符合心肺健康标准，并无已知的心血管疾病，为了确保研究的安全性，所有参与者在实验开始前将进行健康问卷筛查，并接受心电图检查，排除潜在的心脏健康风险，以减少不良事件的可能性。受试者不得患有严重心血管疾病、呼吸系统疾病或影响运动能力的疾病，无严重心理障碍或精神疾病；过去三个月内未参与过系统的高强度间歇训练（HIIT）或抗阻训练（RT）；受试者需自愿参与，并签署知情同意书，了解研究目的、内容、风险与收益，承诺按计划完成所有运动干预和数据采集。

Inclusion criteria

The participants are full-time college students aged 18 to 30 years from Shihezi University, regardless of gender. The participants’ BMI must be between 25 and 40, meeting the criteria for overweight and obesity. Male waist circumference >=90 cm, female waist circumference >=85 cm; WHR for males >=0.9, females >=0.85; and BRI between 4.0 and 14.0. Participants must meet cardiopulmonary health standards and have no known cardiovascular diseases. To ensure the safety of the study, all participants will undergo a health questionnaire screening and an electrocardiogram (ECG) examination before the start of the experiment to rule out potential cardiac health risks and reduce the possibility of adverse events. Participants must not have severe cardiovascular diseases, respiratory diseases, or diseases that affect physical performance. They must not have severe psychological disorders or mental illnesses. Participants must not have engaged in systematic high-intensity interval training (HIIT) or resistance training (RT) in the past three months. Participants must voluntarily participate, sign an informed consent form, understand the purpose, content, risks, and benefits of the study, and commit to completing all exercise interventions and data collection as planned.

排除标准：

石河子大学体育专业的学生将被排除；有冠心病、心力衰竭、高血压或心律失常等心血管疾病史者将被排除；患有哮喘或慢性阻塞性肺疾病（COPD）的受试者将被排除；已确诊糖尿病或严重代谢综合征者将被排除，尤其是使用胰岛素治疗的患者；过去一个月内体重波动超过 2 公斤的受试者也不纳入研究；受试者若在最近 6 个月内有严重骨骼肌肉损伤史，或确诊有严重的心理健康问题（如抑郁症、焦虑症），将被排除；过去 3 个月内参与过高强度间歇训练（HIIT）或抗阻训练（RT）计划的受试者将被排除；正在服用影响代谢、心肺功能的药物（如降糖药、类固醇、β受体阻滞剂等）或长期使用影响代谢的保健品者将被排除；怀孕、免疫系统疾病或医生认为不适合参与高强度运动者将被排除；受试者如有吸烟、酗酒、熬夜或其他可能影响健康的生活习惯，将被排除。

Exclusion criteria：

Students majoring in sports at Shihezi University will be excluded. Individuals with a history of cardiovascular diseases, such as coronary heart disease, heart failure, hypertension, or arrhythmias, will be excluded. Participants with asthma or chronic obstructive pulmonary disease (COPD) will also be excluded. Those diagnosed with diabetes or severe metabolic syndrome, particularly those on insulin therapy, will not be included. Participants with body weight fluctuations exceeding 2 kilograms in the past month will be excluded. Individuals with a history of severe musculoskeletal injuries within the last six months or diagnosed with serious mental health issues (e.g., depression, anxiety) will also be excluded. Participants who have engaged in high-intensity interval training (HIIT) or resistance training (RT) programs within the past three months will not be included. Those taking medications affecting metabolism or cardiopulmonary function (e.g., hypoglycemic agents, steroids, beta-blockers) or long-term users of metabolism-affecting supplements will be excluded. Pregnant individuals, those with immune system diseases, or those deemed unfit for high-intensity exercise by a physician will be excluded. Participants with unhealthy lifestyle habits such as smoking, excessive drinking, staying up late, or other behaviors potentially affecting health will also be excluded.

研究实施时间：

Study execute time：

从 From 2024-10-29 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-10-29 00:00:00 至 To 2026-03-30 00:00:00  

干预措施：

Interventions：

组别：

高强度间歇训练组

样本量：

29

Group：

High intensity interval training group

Sample size：

干预措施：

受试者每周进行3次训练。训练遵循“循序渐进”、“FIIT-VP”原则设计，每次训练包括5分钟热身、高强度间歇训练和10分钟冷却放松。5分钟低强度风阻车热身，旨在提升体温和肌肉活性，为后续高强度训练做好准备。高强度间歇训练：包括多轮高强度运动与低强度恢复交替进行的训练，目标心率不低于最大心率的80%~85%之间（高强度工作阶段），恢复阶段为50%-60%。高强度训练与低强度恢复阶段交替进行，每次循环高强度训练时间10~15秒，每次循环低强度恢复时间10~30秒，每周高强度间歇训练循环24次~30次。随着研究的进展，训练强度或持续时间将逐步增加，以确保参与者能够逐步适应并提高训练效果。10分钟冷却放松进行低强度有氧运动和泡沫轴放松，帮助恢复心率、血压和肌肉状态。

干预措施代码：

Intervention：

Subjects will participate in training sessions three times per week. The training program is designed following the principles of "progressive overload" and "FIIT-VP" (Frequency, Intensity, Time, Type, Volume, and Progression). Each session includes a 5-minute warm-up, high-intensity interval training (HIIT), and a 10-minute cool-down. Warm-up: A 5-minute low-intensity cycling session on a wind-resistance bike aims to increase body temperature and muscle activation, preparing the participants for subsequent high-intensity training. High-Intensity Interval Training: The HIIT consists of multiple rounds alternating between high-intensity exercise and low-intensity recovery. During the high-intensity phases, the target heart rate is 80%-85% of the participant's maximum heart rate, while during the recovery phases, it is maintained at 50%-60%. Each cycle includes 10-15 seconds of high-intensity exercise followed by 10-30 seconds of low-intensity recovery. Weekly sessions comprise a total of 24 to 30 HIIT cycles. As the study progresses, the training intensity or duration will gradually increase to ensure participants adapt and improve their performance effectively. Cool-down: The 10-minute cool-down includes low-intensity aerobic exercise and foam rolling to aid in the recovery of heart rate, blood pressure, and muscle condition.

Intervention code：

组别：

抗阻训练组

样本量：

29

Group：

Resistance training group

Sample size：

干预措施：

RT组每周进行3次，主要针对大肌群的复合动作，采用循环训练法以自重方式进行。每次循环每个动作重复次数10~15次，每周抗阻训练循环次数12~18次。

干预措施代码：

Intervention：

The RT group will train three times per week, focusing on compound movements targeting major muscle groups. A circuit training method will be employed using bodyweight exercises. Each movement in the circuit will be repeated 10-15 times per set, with a total of 12-18 training circuits completed per week.

Intervention code：

组别：

高强度间歇训练联合抗阻训练组

样本量：

29

Group：

High intensity interval training AND Resistance training group

Sample size：

干预措施：

训练内容包含高强度间歇训练组和抗阻训练组的训练内容，每周进行 3 次，但训练频率与抗阻训练交替进行，不安排在同一天。随着研究的进展，将对训练的种类、强度和组数进行适应性调整，以确保肌肉力量和耐力的逐步提升。

干预措施代码：

Intervention：

The training program includes both high-intensity interval training (HIIT) and resistance training (RT), conducted three times per week. However, the sessions alternate between HIIT and RT, ensuring that both types of training are not scheduled on the same day. As the study progresses, the type, intensity, and number of sets will be adaptively adjusted to ensure a gradual improvement in muscle strength and endurance.

Intervention code：

组别：

碎片化运动组

样本量：

29

Group：

Fragmented movement group

Sample size：

干预措施：

碎片化楼梯冲刺训练组每日重复 3 次，每周进行 3 日。训练时间不超过 30 秒钟，每两次训练间歇时间不少于 1 小时。每次训练强度保持在不小于最大心率的 80%，且贯穿 1-8 周。

干预措施代码：

Intervention：

The fragmented stair sprint training group will perform three sessions daily, three days per week. Each session will last no more than 30 seconds, with an interval of at least 1 hour between sessions. The training intensity will be maintained at no less than 80% of the maximum heart rate and will be sustained throughout weeks 1 to 8.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 新疆维吾尔自治区 

市(区县)：

 石河子市 

Country：

China 

Province：

Xinjiang Uygur Autonomous Region 

City：

Shihezi City 

单位(医院)：

石河子大学 

单位级别：

大学 

Institution
hospital：

Shihezi University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

血脂

指标类型：

主要指标

Outcome：

Lipid profile

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

身体成分

指标类型：

主要指标

Outcome：

Body composition

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血糖

指标类型：

主要指标

Outcome：

Blood glucose

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

最大摄氧量

指标类型：

主要指标

Outcome：

Maximal oxygen uptake (VO? max)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肺活量

指标类型：

主要指标

Outcome：

Lung capacity

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肺功能

指标类型：

主要指标

Outcome：

Lung function

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血尿酸

指标类型：

次要指标

Outcome：

Blood uric acid

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心理健康指标

指标类型：

次要指标

Outcome：

Mental health indicators

Type：

Secondary 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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 30 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）：

随机分配序列采用简单随机化计算机生成随机数生成。

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

The randomization sequence will be generated using simple randomization via computer-generated random numbers.

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：

数据分析人员保持盲态（数据分析人员盲）

Blinding：

The data analysts remain blinded (blinded data analysts).

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）：

我们计划在研究结束后公开本研究的原始数据，以支持数据共享和科研透明性。原始数据将通过开放的网络平台进行共享，具体安排如下： 平台名称：ResMan 临床试验公共管理平台（Clinical Trial Management Public Platform） 网址：http://www.medresman.org.cn/ 公开原始数据日期：计划在数据分析完成后，于2026年6月1日公开。

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

We plan to make the raw data of this study publicly available after the completion of the research to support data sharing and research transparency. The raw data will be shared through an open online platform. The specific details are as follows: Platform Name: ResMan Clinical Trial Management Public Platform Website: http://www.medresman.org.cn/ Date of Raw Data Release: The raw data is planned to be made publicly available on June 1, 2026, after the data analysis is completed.

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：

本研究的数据采集和管理分为以下两部分： 1.病例记录表（Case Record Form, CRF） 研究中所有相关数据将通过标准化的病例记录表（CRF）进行采集。CRF 将涵盖研究设计的所有关键信息，包括基线特征、干预措施、随访结果和不良事件记录等。所有纸质或电子版 CRF 将由经过培训的研究人员填写，以确保数据的准确性和一致性。 2.电子采集和管理系统（Electronic Data Capture, EDC） 数据将录入基于互联网的电子数据采集和管理系统 ResMan 公共管理平台，网址为 http://www.medresman.org。ResMan 系统具有实时数据录入、自动校验和安全存储的功能，能够有效减少数据输入错误并提高数据质量。系统操作由授权人员执行，所有数据均受密码保护，只有经过授权的研究团队成员可以访问。 数据采集和管理将严格遵循伦理委员会的要求及相关法律法规，确保参与者隐私和数据安全的保护，同时保证数据的完整性和科学性。

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

Data Collection and Management This study’s data collection and management are divided into the following two parts: Case Record Form (CRF) All relevant data in this study will be collected using standardized Case Record Forms (CRFs). The CRFs will include all critical information outlined in the study design, such as baseline characteristics, interventions, follow-up outcomes, and records of adverse events. All paper-based or electronic CRFs will be completed by trained research personnel to ensure accuracy and consistency of the data. Electronic Data Capture (EDC) Data will be entered into the internet-based Electronic Data Capture (EDC) system ResMan Public Management Platform, accessible at http://www.medresman.org. The ResMan system features real-time data entry, automatic validation, and secure storage functions, which effectively minimize data entry errors and enhance data quality. The system will be operated by authorized personnel, and all data will be password-protected, with access limited to authorized members of the research team. Data collection and management will strictly adhere to the requirements of the ethics committee and relevant laws and regulations, ensuring the protection of participant privacy and data security, as well as maintaining the integrity and scientific validity of the data.

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：

  2024-12-13 17:26:56