ChiCTR2500101071 版本V1.0 版本创建时间2025/04/18 16:21:33 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:

ChiCTR2500101071 

最近更新日期:

Date of Last Refreshed on:

2025-04-18 16:21:29 

注册时间:

Date of Registration:

2025-04-18 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

冷疗联合动态拉伸对在校男篮运动员运动后疲劳的恢复作用

Public title:

The recovery effect of cold water immersion combined with dynamic stretching on the fatigue of male basketball players at school after exercise

注册题目简写:

English Acronym:

研究课题的正式科学名称:

冷疗联合动态拉伸对在校男篮运动员运动后疲劳的恢复作用

Scientific title:

The recovery effect of cold water immersion combined with dynamic stretching on the fatigue of male basketball players at school after exercise

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:

何剑 

研究负责人:

郑尉 

Applicant:

Jian He 

Study leader:

Wei Zheng 

申请注册联系人电话:

Applicant telephone:

+86 132 0954 5130

研究负责人电话:

Study leader's
telephone:

+86 134 0112 2596

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:

HeJian_5130@163.com

研究负责人电子邮件:

Study leader's E-mail:

zhengwei1020@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:

天津市静海区东海道16号

研究负责人通讯地址:

天津市静海区东海道16号

Applicant address:

No. 16, Dongkaido, Jinghai District, Tianjin

Study leader's address:

No. 16, Dongkaido, Jinghai District, Tianjin

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:

天津体育学院运动健康学院

Applicant's institution:

College of Sports and Health,Tianjin University of Sport

研究负责人所在单位:

天津体育学院运动健康学院

Affiliation of the Leader:

College of Sports and Health,Tianjin University of Sport

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:

TJUS2025-055

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:

天津体育学院伦理委员会

Name of the ethic committee:

Ethics Committee of Tianjin University of Sport

伦理委员会批准日期:

Date of approved by ethic committee:

2025-04-18 00:00:00

伦理委员会联系人:

郑尉

Contact Name of the ethic committee:

Wei Zheng

伦理委员会联系地址:

天津市静海区东海道16号

Contact Address of the ethic committee:

No. 16, Dongkaido, Jinghai District, Tianjin

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 134 0112 2596

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:

天津体育学院运动健康学院

Primary sponsor:

College of Sports and Health,Tianjin University of Sport

研究实施负责(组长)单位地址:

天津市静海区东海道16号

Primary sponsor's address:

No. 16, Dongkaido, Jinghai District, Tianjin

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津体育学院运动健康学院

具体地址:

天津市静海区东海道16号

Institution
hospital:

College of Sports and Health,Tianjin University of Sport

Address:

No. 16, Dongkaido, Jinghai District, Tianjin

经费或物资来源:

其他

Source(s) of funding:

Other

研究疾病:

运动性疲劳  

Target disease:

Patellofemoral pain syndrome

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:

探索性研究/预试验 

Study phase:

0

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

1. 评估冷疗联合动态拉伸对篮球运动员运动后疲劳的恢复效果。 2. 比较冷疗联合动态拉伸与单一冷疗在恢复效果上的差异。 3. 为篮球运动员制定有效的运动后疲劳恢复方案提供科学依据。  

Objectives of Study:

1.To evaluate the recovery effect of cold water immersion combined with dynamic stretching on post-exercise fatigue of basketball players. 2. Compare the differences in recovery effects between cold water immersion combined with dynamic stretching and cold water immersion alone. 3. Provide a scientific basis for basketball players to formulate effective post-exercise fatigue recovery plans.

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年龄在 18-25 岁之间的男性,且为在校在读的男篮运动员;②受试者需至少有 2 年及以上的系统篮球训练经历;③经检查确认身体健康,无其他疾病;④研究前征得参与者的同意,告知其干预方法以及研究目的和意义,签署知情同意书

Inclusion criteria

1 Male players aged between 18 and 25 who are currently enrolled in the men's basketball team. 2 The subjects need to have at least two years or more of systematic basketball training experience. 3 After examination, it was confirmed that the person is in good health and has no other diseases. 4 Before the study, obtain the consent of the participants, inform them of the intervention methods as well as the purpose and significance of the study, and sign the informed consent form

排除标准:

①对冷疗过敏或有不良反应;②近一个月内有感冒、发烧、服用抗炎性药物等行为影响机体免疫力和疲劳恢复;③有吸烟、酗酒等不良习惯

Exclusion criteria:

1 Allergic to cold therapy or having adverse reactions; 2 Within the past month, there have been behaviors such as catching a cold, having a fever, or taking anti-inflammatory drugs that affect the body's immunity and fatigue recovery. 3 Have bad habits such as smoking and excessive drinking

研究实施时间:

Study execute time:

From 2025-04-30 00:00:00 To 2025-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-05-01 00:00:00 To 2025-05-10 00:00:00

干预措施:

Interventions:

组别:

干预组

样本量:

24

Group:

Intervention group

Sample size:

干预措施:

冷水浴采用标准冷水池,受试者坐在水池中,要求水深覆盖至胸骨中段,时间为10min; 在进行完冷水浴后进行动态拉伸,时间为5min

干预措施代码:

Intervention:

The cold water bath adopted a standard cold water pool. The subjects sat in the pool, and the water depth was required to cover the middle section of the sternum for 10 minutes; After the cold water bath, perform dynamic stretching for 5 minutes

Intervention code:

组别:

对照组

样本量:

24

Group:

Control group

Sample size:

干预措施:

冷水浴采用标准冷水池,受试者坐在水池中,要求水深覆盖至胸骨中段,时间为15min

干预措施代码:

Intervention:

The cold water bath adopted a standard cold water pool. The subjects sat in the pool, and the water depth was required to cover the middle section of the sternum for 15 minutes

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

天津 

市(区县):

 

Country:

China

Province:

tianjin

City:

单位(医院):

天津体育学院 

单位级别:

大学 

Institution
hospital:

Tianjin University of Sport

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

自觉疲劳程度得分

指标类型:

主要指标

Outcome:

rating of perceived exertion,rpe

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

积分肌电值

指标类型:

主要指标

Outcome:

iEMG

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

垂直纵跳高度

指标类型:

主要指标

Outcome:

Counter movement jump,CMJ

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:

Sample Name:

None

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 25 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):

由康复治疗师采用 Execl 随机数表法将 48名受试者随机分为干预组和对照组.

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

Forty-eight subjects were randomly divided into the intervention group and the control group by the rehabilitation therapist using the EXCEL random number table method.

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:

Blinding:

None

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

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):

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

None

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:

病例记录表

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

Case Record Form

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:

 2025-04-18 16:21:29