ChiCTR2500106395 版本V1.0 版本创建时间2025/07/23 10:38:18 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:

ChiCTR2500106395 

最近更新日期:

Date of Last Refreshed on:

2025-07-23 10:35:55 

注册时间:

Date of Registration:

2025-07-23 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

不同强度间歇训练与持续训练对久坐男大学生健康体适能与血流动力学的影响研究

Public title:

A Study on the Effects of Different Intensity Interval Training and Continuous Training on the Health Fitness and Hemodynamics of Sedentary Male College Students

注册题目简写:

English Acronym:

研究课题的正式科学名称:

不同强度间歇训练与持续训练对久坐男大学生健康体适能与血流动力学的影响研究

Scientific title:

A Study on the Effects of Different Intensity Interval Training and Continuous Training on the Health Fitness and Hemodynamics of Sedentary Male 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:

郑魏华 

研究负责人:

朴顺哲 

Applicant:

weihua zheng 

Study leader:

shunzhe piao 

申请注册联系人电话:

Applicant telephone:

+86 186 9570 7973

研究负责人电话:

Study leader's
telephone:

+86 182 0240 9929

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:

1641986147@qq.com

研究负责人电子邮件:

Study leader's E-mail:

2428595988@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:

辽宁省沈阳市苏家屯区金钱松东路36号

研究负责人通讯地址:

辽宁省沈阳市苏家屯区金钱松东路36号

Applicant address:

36 Qiansong East Road, Sujiatun District, Shenyang, Liaoning

Study leader's address:

36 Qiansong East Road, Sujiatun District, Shenyang, Liaoning

申请注册联系人邮政编码:

Applicant postcode:

110102

研究负责人邮政编码:

Study leader's postcode:

110102

申请人所在单位:

沈阳体育学院

Applicant's institution:

Shenyang Sport University

研究负责人所在单位:

沈阳体育学院

Affiliation of the Leader:

Shenyang 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:

[2025]8

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:

沈阳体育学院伦理委员会

Name of the ethic committee:

Shenyang Sport University Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2025-06-10 00:00:00

伦理委员会联系人:

张广志

Contact Name of the ethic committee:

zhangguangzhi

伦理委员会联系地址:

辽宁省沈阳市苏家屯区金钱松东路36号

Contact Address of the ethic committee:

36 Qiansong East Road, Sujiatun District, Shenyang, Liaoning

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 24 8916 6627

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:

沈阳体育学院

Primary sponsor:

Shenyang Sport University

研究实施负责(组长)单位地址:

辽宁省沈阳市苏家屯区金钱松东路36号

Primary sponsor's address:

36 Qiansong East Road, Sujiatun District, Shenyang, Liaoning

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

辽宁

市(区县):

Country:

China

Province:

Liaoning

City:

单位(医院):

沈阳体育学院

具体地址:

辽宁省沈阳市苏家屯区金钱松东路36号

Institution
hospital:

Shenyang Sport University

Address:

36 Qiansong East Road, Sujiatun District, Shenyang, Liaoning

经费或物资来源:

自费

Source(s) of funding:

Self-funded

研究疾病:

无  

Target disease:

None

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:

随着久坐生活方式的普及,大学生中久坐行为日益严重,已成为心血管代谢疾病和身体素质下降的重要诱因。本研究旨在比较不同强度的间歇训练与持续训练对久坐男大学生健康体适能(身体成分、心肺适能、肌肉适能、柔韧适能)和血流动力学指标(血压、心率、心率血压乘积)的干预效果,探索最适合该人群的运动干预模式,为制定科学的运动干预方案提供依据。  

Objectives of Study:

With the increasing prevalence of sedentary lifestyles, sedentary behavior has become increasingly common among university students and is now a major contributing factor to cardiometabolic diseases and the decline of physical fitness. This study aims to compare the intervention effects of interval training and continuous training at different intensities on health-related physical fitness (body composition, cardiorespiratory fitness, muscular fitness, and flexibility) and hemodynamic indicators (blood pressure, heart rate, and rate-pressure product) in sedentary male college students. The goal is to identify the most suitable exercise intervention model for this population and to provide evidence for developing scientifically sound exercise intervention programs.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

纳入标准: (1)年龄18-25岁以上,性别为男性; (2)无规律运动习惯(每日累计久坐时间达到≥ 7h ,参与中等至剧烈的身体活动< 150 min/w)进行体力活动问卷(The International Physical Activity Questionnaire,IPAQ)评估; (3)无运动禁忌症,无色盲、视力障碍等疾病或精神疾病; (4)愿意参加本研究,签署知情同意书。

Inclusion criteria

Inclusion Criteria: (1) Male individuals aged 18–25 years; (2) No regular exercise habits (total daily sedentary time ≥ 7 hours and engaging in moderate-to-vigorous physical activity < 150 minutes per week), as assessed by the International Physical Activity Questionnaire (IPAQ); (3) No contraindications to exercise, and free from color blindness, visual impairments, or mental disorders; (4) Willing to participate in the study and sign an informed consent form.

排除标准:

排除标准: (1)参加其他运动训练项目的受试者; (2)全人群体力活动准备问卷(2020PAR-Q+)调查存在任何膝盖、下背部疼痛或任何心血管相关疾病的受试者; 缺失训练3次及以上的受试者

Exclusion criteria:

Exclusion Criteria: (1) Participants who are engaged in other exercise training programs; (2) Participants who report any knee or lower back pain, or any cardiovascular-related diseases, based on the 2020 Physical Activity Readiness Questionnaire for Everyone (2020 PAR-Q+); (3) Participants who miss three or more training sessions.

研究实施时间:

Study execute time:

From 2025-07-01 00:00:00 To 2025-11-07 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-07-23 00:00:00 To 2025-07-28 00:00:00

干预措施:

Interventions:

组别:

HIIT

样本量:

10

Group:

HIIT

Sample size:

干预措施:

组合1:开合跳+卷腹+双手触底地跳 组合2:高抬腿+壶铃摇摆+波比跳 组合3:连续弓步跳前平举+屈体俯卧撑+箭步小跳

干预措施代码:

1

Intervention:

Combination 1: Jumping jacks + Crunches + Squat jumps with both hands touching the floor Combination 2: High knees + Kettlebell swings + Burpees Combination 3: Continuous lunge jumps with front arm raises + Pike push-ups + Lunge hops

Intervention code:

组别:

MIIT

样本量:

10

Group:

MIIT

Sample size:

干预措施:

组合1:简易开合跳+卷腹+双手触底地蹲 组合2:抬膝踏步+壶铃摇摆+原地冲拳 组合3:连续弓步跳前平举+屈体俯卧撑+箭步小跳

干预措施代码:

2

Intervention:

Combination 1: Modified jumping jacks + Crunches + Squats with both hands touching the floor Combination 2: Knee lifts in place + Kettlebell swings + Shadow boxing in place Combination 3: Continuous lunge jumps with front arm raises + Pike push-ups + Lunge hops

Intervention code:

组别:

HICT

样本量:

10

Group:

HICT

Sample size:

干预措施:

组合1:开合跳+卷腹+双手触底地跳 组合2:高抬腿+壶铃摇摆+波比跳 组合3:连续弓步跳前平举+屈体俯卧撑+箭步小跳

干预措施代码:

3

Intervention:

Combination 1: Jumping jacks + Crunches + Squat jumps with both hands touching the floor Combination 2: High knees + Kettlebell swings + Burpees Combination 3: Continuous lunge jumps with front arm raises + Pike push-ups + Lunge hops

Intervention code:

组别:

MICT

样本量:

10

Group:

MICT

Sample size:

干预措施:

组合1:简易开合跳+卷腹+双手触底地蹲 组合2:抬膝踏步+壶铃摇摆+原地冲拳 组合3:连续弓步跳前平举+屈体俯卧撑+箭步小跳

干预措施代码:

4

Intervention:

Combination 1: Modified jumping jacks + Crunches + Squats with both hands touching the floor Combination 2: Knee lifts in place + Kettlebell swings + Shadow boxing in place Combination 3: Continuous lunge jumps with front arm raises + Pike push-ups + Lunge hops

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

辽宁 

市(区县):

 

Country:

China

Province:

Liao Ning

City:

单位(医院):

沈阳体育学院 

单位级别:

大学 

Institution
hospital:

Shenyang Sport University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

身体成分

指标类型:

主要指标

Outcome:

BMI

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高

指标类型:

次要指标

Outcome:

height

Type:

Secondary 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:

waistline

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:

臀围

指标类型:

主要指标

Outcome:

hipline

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:

VO2max

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

握力

指标类型:

主要指标

Outcome:

grip

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

立定跳远

指标类型:

主要指标

Outcome:

standing long jump

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

1min仰卧起做

指标类型:

主要指标

Outcome:

1 minute of sit-ups

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

1min俯卧撑测试俯卧撑

指标类型:

主要指标

Outcome:

1min push-up test

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

坐位体前屈

指标类型:

主要指标

Outcome:

Seated forward bend

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

主要指标

Outcome:

heart rate

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

主要指标

Outcome:

blood pressure

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动享受量表

指标类型:

主要指标

Outcome:

Physical Activity Enjoyment Scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动活动享受问卷

指标类型:

主要指标

Outcome:

Exercise Enjoyment Questionnaire

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

感受量表

指标类型:

主要指标

Outcome:

Feeling Scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主观疲劳程度量表

指标类型:

主要指标

Outcome:

Rating of Perceived Exertion

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:

组织:

none

Sample Name:

None

Tissue:

none

人体标本去向

使用后销毁  

说明

none

Fate of sample:

Destruction after use  

Note:

none

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 20 years
最大 Max age 27 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

为确保受试者分组的随机性和过程的独立性,本研究采用信封法实施随机分组。由非参与干预和评估的第三方研究人员,使用Excel随机数函数生成等比例的分组标签(HIIT、HICT、MIIT、MICT),将其分别装入编号的不透明信封中。准备好不透明信封,分别编号将打乱后放入信封中,在受试者完成基线评估并签署知情同意书后,按入组顺序依次抽取信封。根据信封内容将受试者分配至相应干预组别。整个过程确保分配隐藏,避免了因预测分组而可能产生的选择性偏倚

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

To ensure the randomness and independence of participant allocation, this study employed the sealed envelope method for randomization. A third-party researcher not involved in the intervention or assessment generated an equal number of group labels (HIIT, HICT, MIIT, MICT) using Excel random functions, and placed them into sequentially numbered opaque envelopes. The opaque envelopes were prepared in advance, numbered, and filled with the randomized group labels. After participants completed baseline assessments and signed the informed consent form, they drew envelopes in the order of enrollment. Participants were assigned to the corresponding intervention group based on the content of the envelope. This process ensured allocation concealment and minimized the risk of selection bias due to foreknowledge of group assignments.

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:

鉴于运动干预的特性,受试者无法实现完全盲法。但为减少评估偏倚,本研究采用单盲设计,即结局评估人员在测试过程中不知晓受试者所属训练组别,评估人员与干预执行人员分离,测试数据由编号匿名处理。此外,数据整理与统计分析阶段由不知晓分组信息的独立人员进行,进一步确保研究的客观性与内部效度。

Blinding:

Due to the nature of exercise interventions, it was not feasible to blind participants to their group assignments. However, a single-blind design was employed in this study. Outcome assessors were blinded to group allocation during all testing procedures to minimize measurement bias. Assessors were independent from the intervention team, and all participant data were anonymized using identification codes. Additionally, data entry and statistical analyses were conducted by independent personnel who were also blinded to group allocation, ensuring objectivity and internal validity of the results.

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):

http://www.medresman.org.cn/loginok.aspx

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

http://www.medresman.org.cn/loginok.aspx

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:

数据采集通过纸质与电子记录表实现,管理通过电子采集与管理系统实现。

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

Data collection was carried out using both paper-based and electronic record forms, while data management was conducted through an electronic data capture and management system.

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:

 2025-07-23 10:35:55