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全身振动训练对老年膝骨关炎患者神经肌肉控制功能影响的研究
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注册号:

Registration number:

ChiCTR-IOR-16009234 

最近更新日期:

Date of Last Refreshed on:

2016-09-21 

注册时间:

Date of Registration:

2016-09-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

全身振动训练对老年膝骨关炎患者神经肌肉控制功能影响的研究 

Public title:

Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

全身振动训练对老年膝骨关炎患者神经肌肉控制功能影响的研究 

Scientific title:

Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis 

研究课题代号(代码):

Study subject ID:

上海科学技术委员会(14490503800) 

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:

王琳 

研究负责人:

王琳 

Applicant:

Lin Wang 

Study leader:

Lin Wang 

申请注册联系人电话:

Applicant telephone:

+86 21 5125 3426*611 

研究负责人电话:

Study leader's telephone:

+86 21 5125 3426*611 

申请注册联系人传真 :

Applicant Fax:

+86 21 5125 3470 

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:

wanglin@sus.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

wanglin@sus.edu.cn 

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:

中国上海市杨浦区恒仁路188号上海体育学院运动科学学院 

研究负责人通讯地址:

中国上海市杨浦区恒仁路188号上海体育学院运动科学学院 

Applicant address:

188 Hengren Road, Yangpu District, Shanghai, China 

Study leader's address:

188 Hengren Road, Yangpu District, Shanghai, China  

申请注册联系人邮政编码:

Applicant postcode:

200438 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海体育学院 

Applicant's institution:

Shanghai University of Sport 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2016-016 

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:

上海体育学院科学研究伦理委员会 

Name of the ethic committee:

The Ethics Committee of Shanghai University of Sport  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

上海体育学院 

Primary sponsor:

Shanghai University of Sport  

研究实施负责(组长)单位地址:

上海市长海路399号 

Primary sponsor's address:

399 Changhai Road, Shanghai  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海体育学院 运动医学康复中心

具体地址:

上海市杨浦区恒仁路188号

Institution
hospital:

Center for Sports Rehabilitation, Shanghai University of Sport

Address:

188 Hengren Road, Yangpu District, Shanghai, China

经费或物资来源:

上海科学技术委员会(14490503800) 

Source(s) of funding:

Shanghai Committee of Science and Technology (14490503800) 

研究疾病:

膝关节骨关节炎 

Target disease:

Knee Osteoarthritis 

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 

研究目的:

本研究旨在验证12周的全身振动训练对老年膝骨关炎患者神经肌肉控制功能的影响。 

Objectives of Study:

This study attempts to investigate the effect of a 12-week WBV exercise on the neuromuscular function of individuals with KOA. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

受试者选择基于美国风湿病协会对膝骨关炎患者的分级标准: 1、男性或女性,经影像学诊断为膝骨关节炎(单侧或双侧),自述疼痛超过3个月; 2、轻、中度膝骨关节炎(Lequesne分数在0到7分之间); 3、年龄在50到70周岁之间; 4、在研究进行期间药物治疗与往常保持一致; 5、在大约2个月的时间内能保证每周3次的训练。 

Inclusion criteria

Participant selection will be based on the classification criteria of the American Rheumatism Association for KOA: 1. Men or women with diagnostic criteria of definite KOA (unilateral or bilateral) according to radiography, with reports of pain symptoms for at least 3 months; 2. Mild to moderate KOA (Lequesne knee score = 1 to 7); 3. Aged 50–70 years; 4. Medication not expected to change during the study period; 5. To be able to complete the training progrom of three times a week over 3 months. 

排除标准:

1、在过去6个月以内有膝关节手术史; 2、骨关节炎急性症状期; 3、有其他肌肉、关节或神经方面的情况影响膝关节功能; 4、不能独立步行; 5、目前正在针对膝骨关节炎进行系统的运动治疗; 6、阿尔茨海默病、帕金森、运动神经元失调; 7、糖尿病、心脏或呼吸系统功能不全、不能理解实验过程。 

Exclusion criteria:

1. Knee surgery in the past 6 months; 2. Acute symptomatic OA; 3. Other muscular, joint, or neurological conditions that affect lower limb function; 4. Unable to walk unaided; 5. Currently undertaking a structured exercise program for KOA; 6. Alzheimers disease, Parkinsons disease, and motor neuron disorders; 7. Diabetes mellitus, cardiac or respiratory insufficiency, and inability to understand the procedure. 

研究实施时间:

Study execute time:

From2016-12-01To 2017-08-31 

征募观察对象时间:

Recruiting time:

From2016-12-01To 2017-03-01 

干预措施:

Interventions:

组别:

全身振动训练组

样本量:

30

Group:

WBV

Sample size:

干预措施:

全身振动训练

干预措施代码:

Intervention:

whole body vibration training

Intervention code:

组别:

力量训练组

样本量:

30

Group:

RT

Sample size:

干预措施:

力量训练

干预措施代码:

Intervention:

lower extremity resistance training

Intervention code:

组别:

对照组

样本量:

30

Group:

Control

Sample size:

干预措施:

健康教育

干预措施代码:

Intervention:

health education

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海体育学院 运动医学康复中心 

单位级别:

研究中心 

Institution
hospital:

Center for Sports Rehabilitation, Shanghai University of Sport  

Level of the institution:

Center for Sports Rehabilitation  

测量指标:

Outcomes:

指标中文名:

身高

指标类型:

主要指标 

Outcome:

Body 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:

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:

疼痛视觉模拟标尺

指标类型:

主要指标 

Outcome:

VAS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

WOMAC关节炎指数问卷

指标类型:

主要指标 

Outcome:

Western Ontario and McMaster Universities Osteoarthritis Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SF-36健康调查问卷

指标类型:

主要指标 

Outcome:

SF-36

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白氏抑郁量表

指标类型:

主要指标 

Outcome:

Beck depression inventory

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Berg平衡量表

指标类型:

主要指标 

Outcome:

The Berg balance 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:

站起走时间

指标类型:

主要指标 

Outcome:

The timed up and go 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:

6分钟步行距离

指标类型:

主要指标 

Outcome:

The 6-minute walk distance 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:

步行及爬楼梯时步态分析

指标类型:

次要指标 

Outcome:

Gait analysis during walking and stair climbing

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝关节屈伸肌肉力量

指标类型:

次要指标 

Outcome:

Knee extensors and flexors strength

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝、踝关节本体感觉

指标类型:

次要指标 

Outcome:

Feeling of knee and ankle joints

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经肌肉反应

指标类型:

次要指标 

Outcome:

Neuromuscular response

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:

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 50 years
最大 Max age 70 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):

满足纳入标准并且同意参加试验的受试者将通过电脑随机分为3组。

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

Participants who meet all study inclusion criteria and consent to participate will be randomly allocated to three groups by using a computer-generated randomization.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

上海体育学院

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

Shanghai University of Sport

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:

上海体育学院

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

Shanghai University of Sport

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-09-21
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