Effect of Velocity Based Training on Patellofemoral Pain in College Students

注册号:

Registration number:

ChiCTR2500096908 

最近更新日期:

Date of Last Refreshed on:

2025-02-08 17:11:41 

注册时间:

Date of Registration:

2025-02-08 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

基于速度的力量训练对髌股关节疼痛大学生干预效果的研究

Public title:

Effect of Velocity Based Training on Patellofemoral Pain in College Students

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于速度的力量训练对髌股关节疼痛大学生干预效果的研究

Scientific title:

Effect of Velocity Based Training on Patellofemoral Pain in 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:

陈昊楠 

研究负责人:

郑尉  

Applicant:

HaoNan Chen 

Study leader:

Wei Zheng 

申请注册联系人电话:

Applicant telephone:

+86 159 5388 6929

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:

dlwlrma0216@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:

天津市静海区团泊新城西区东海道16号

研究负责人通讯地址:

天津市静海区团泊新城西区东海道16号

Applicant address:

16 Donghai Road, Tuanbo Xincheng West District, Jinghai District, Tianjin

Study leader's address:

16 Donghai Road, Tuanbo Xincheng West District, Jinghai District, Tianjin

申请注册联系人邮政编码:

Applicant postcode:

301617

研究负责人邮政编码:

Study leader's postcode:

301617

申请人所在单位:

天津体育学院

Applicant's institution:

TianJin University of Sport

研究负责人所在单位:

天津体育学院

Affiliation of the Leader:

TianJin University of Sport

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:

TJUS2024-066

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:

2025-01-03 00:00:00

伦理委员会联系人:

谭洋洋

Contact Name of the ethic committee:

YangYang Tan

伦理委员会联系地址:

天津市静海区团泊新城西区东海道16号

Contact Address of the ethic committee:

16 Donghai Road, Tuanbo Xincheng West District, Jinghai District, Tianjin

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 23935080

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

Primary sponsor:

Tianjin University of Sport

研究实施负责(组长)单位地址:

天津市静海区团泊新城西区东海道16号

Primary sponsor's address:

16 Donghai Road, Tuanbo Xincheng West District, 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

具体地址:

天津市静海区团泊新城西区东海道16号

Institution
hospital:

Tianjin University of Sport

Address:

16 Donghai Road, Tuanbo Xincheng West District, Jinghai District, Tianjin

经费或物资来源:

科研基金

Source(s) of funding:

Research fund

Target disease:

Patellofemoral pain

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)探究基于速度的力量训练以及传统力量训练能否改善PFP患者的疼痛、膝关节功能、下肢生物力学特征以及相对峰力矩等指标。 (2)比较基于速度的力量训练与传统力量训练间干预效果的差异。  

Objectives of Study:

(1) To explore whether velocity based training and traditional strength training can improve pain, knee function, lower extremity biomechanical characteristics and peak torque to body weight in PFP patients. (2) Compare the difference of intervention effect between velocity based training and traditional strength training.

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)男性在校大学生,且年龄在18-30岁之间; (2)疼痛主要位于髌股关节区域,单腿下蹲测试中主观疼痛评分3分及以上; (3)在下蹲、上下楼梯、长久坐位或其他使髌股关节在屈曲位置负荷的功能活动时于髌后或髌周出现疼痛。

Inclusion criteria

(1) Male college students between the ages of 18 and 30; (2) The pain was mainly located in the patellofemoral joint area, and the visual analog pain scale score was 3 or above in the one-leg squat test; (3) postpatellar or peripatellar pain during squatting, walking up and down stairs, prolonged sitting, or other functional activities that load the patellofemoral joint in the flexion position.

排除标准:

(1)有明显的外伤史,例如关节骨折、严重扭伤等; (2)存在下肢手术史; (3)有其他明显的髋、踝等下肢关节部位疼痛; (4)6个月内接受过系统康复治疗者。

Exclusion criteria:

(1) There is an obvious history of trauma, such as joint fracture, severe sprain, etc; (2) History of lower extremity surgery; (3) There are other obvious hip, ankle and other lower limb joint pain; (4) Those who have received systematic rehabilitation treatment within 6 months.

研究实施时间:

Study execute time:

From 2025-02-20 00:00:00 To 2025-04-20 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-02-20 00:00:00 To 2025-03-02 00:00:00  

干预措施:

Interventions:

组别:

实验组

样本量:

16

Group:

Experimental group

Sample size:

干预措施:

基于速度的力量训练

干预措施代码:

Intervention:

Velocity based strength training

Intervention code:

组别:

对照组

样本量:

16

Group:

Control group

Sample size:

干预措施:

传统力量训练

干预措施代码:

Intervention:

Traditional strength training

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:

视觉疼痛模拟评分

指标类型:

主要指标

Outcome:

Visual Analog 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:

膝前痛量表

指标类型:

主要指标

Outcome:

Anterior Knee Pain 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:

下肢生物力学特征

指标类型:

主要指标

Outcome:

Biomechanical Characteristics of Lower Limbs

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

相对峰力矩

指标类型:

主要指标

Outcome:

Peak Torque to Body 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:

疲劳与负荷量

指标类型:

次要指标

Outcome:

Fatigue and Load

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:

组织:

Sample Name:

None

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 30 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):

依据SPSS 26.0软件产生的随机数,将所有受试者随机分为实验组(n=16)、对照组(n=16)。

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

All subjects were randomly divided into an experimental group (n=16) and a control group (n=16) based on the random numbers generated by SPSS 26.0 software.

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:

对受试者进行单盲设计

Blinding:

The study employed a single-blind design for the subjects.

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):

于2025.9.30上传ResMan(http://www.medresman.org.cn/login.aspx)

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

Uploaded ResMan on 2025.9.30 (http://www.medresman.org.cn/login.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:

实验记录表+基于resman的 EDC系统

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

Experiment log sheet + resman based EDC 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:

 2025-02-08 17:11:32