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The effects of strength training in knee osteoarthritis patients
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注册号：

Registration number：

 ChiCTR2000034570 

最近更新日期：

Date of Last Refreshed on：

 2020-07-10 10:05:20 

注册时间：

Date of Registration：

 2020-07-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The effects of strength training in knee osteoarthritis patients

Public title：

The effects of strength training in knee osteoarthritis patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effects of progressive resistance strength training on pain, mobility and activities of daily living among knee osteoarthritis patients

Scientific title：

The effects of progressive resistance strength training on pain, mobility and activities of daily living among knee osteoarthritis patients

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：

Muhammad Tariq Rafiq  

研究负责人：

Muhammad Irfan Khan 

Applicant：

Muhammad Tariq Rafiq  

Study leader：

Muhammad Irfan Khan 

申请注册联系人电话：

Applicant telephone：

 +92 321 4495948

研究负责人电话：

Study leader's
telephone：

+923334323094

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：

 drtariqrafiq149@yahoo.com

研究负责人电子邮件：

Study leader's E-mail：

 drirfanmayo@gmail.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：

135-B, Eden Lane Villas-1, Raiwind Road Lahore, Pakistan

研究负责人通讯地址：

135-B, Eden Lane Villas-1, Raiwind Road Lahore, Pakistan

Applicant address：

135-B, Eden Lane Villas-1, Raiwind Road Lahore, Pakistan

Study leader's address：

135-B, Eden Lane Villas-1, Raiwind Road Lahore, Pakistan

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：

巴基斯坦拉合尔木尔坦路木尔坦崇基旁遮普雇员社会保障机构心脏病学研究生院

Applicant's institution：

Rehmatul-Lil-Alamine Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road, Lahore, Pakistan

研究负责人所在单位：

巴基斯坦拉合尔玛约医院理疗康复科

Affiliation of the Leader：

Physical Medicine and Rehabilitation, Mayo Hospital Lahore

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：

 RAIC PESSI/Estt/2020/22

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Ethical Committee RAIC PESSI

Name of the ethic committee：

Ethical Committee RAIC PESSI

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

Dr Farid Ahmad Chaudhary

Contact Name of the ethic committee：

Dr Farid Ahmad Chaudhary

伦理委员会联系地址：

Rehmatul-Lil-Alamine Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore, Pakistan

Contact Address of the ethic committee：

Rehmatul-Lil-Alamine Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore, Pakistan

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：

Medical Superintendent, Dr Farid Ahmad Chaudhary

Primary sponsor：

Medical Superintendent, Dr Farid Ahmad Chaudhary

研究实施负责（组长）单位地址：

Rehmatul-Lil-Alamine Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore, Pakistan

Primary sponsor's address：

Rehmatul-Lil-Alamine Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

马来西亚

省(直辖市)：

Selangor

市(区县)：

Kuala Lumpur

Country：

Malaysia

Province：

Selangor

City：

Kuala Lumpur

单位(医院)：

Centre for Sport and Exercise Sciences

具体地址：

Centre for Sport and Exercise Sciences, University of Malaya, Kuala Lumpur, Malaysia

Institution
hospital：

Centre for Sport and Exercise Sciences

Address：

Centre for Sport and Exercise Sciences, University of Malaya, Kuala Lumpur, Malaysia

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

knee osteoarthritis  

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：

 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：

The objective of this study was to investigate the effects of progressive resistance strength training of lower limb rehabilitation protocol on pain, mobility and activities of daily living among knee osteoarthritis patients who are overweight or obese  

Objectives of Study：

The objective of this study was to investigate the effects of progressive resistance strength training of lower limb rehabilitation protocol on pain, mobility and activities of daily living among knee osteoarthritis patients who are overweight or obese

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

Rheumatoid arthritis; System lupus erythematosus; History of metabolic, hormonal, orthopaedic, cardiovascular disease; spinal deformities; Surgery of knee/s of any cause; Any injections of knee/s for the last six months or unwilling to participate

Exclusion criteria：

Rheumatoid arthritis; System lupus erythematosus; History of metabolic, hormonal, orthopaedic, cardiovascular disease; spinal deformities; Surgery of knee/s of any cause; Any injections of knee/s for the last six months or unwilling to participate

研究实施时间：

Study execute time：

从 From 2020-03-30 00:00:00至 To 2020-10-29 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-07-16 00:00:00 至 To 2020-10-15 00:00:00

干预措施：

Interventions：

组别：

Rehabilitation Protocol Group

样本量：

 28

Group：

Rehabilitation Protocol Group

Sample size：

干预措施：

The participants in the Rehabilitation Protocol Group will perform the intervention of progressive resistance strength training of lower limb rehabilitation protocol following the instructions of daily care for duration of 12-weeks.

干预措施代码：

Intervention：

The participants in the Rehabilitation Protocol Group will perform the intervention of progressive resistance strength training of lower limb rehabilitation protocol following the instructions of daily care for duration of 12-weeks.

Intervention code：

组别：

Control Group

样本量：

 28

Group：

Control Group

Sample size：

干预措施：

The participants in the Control Group will follow the intervention of instructions of daily care for duration of 12-weeks.

干预措施代码：

Intervention：

The participants in the Control Group will follow the intervention of instructions of daily care for duration of 12-weeks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 旁遮普 

市(区县)：

 拉合尔 

Country：

Pakistan

Province：

Punjab

City：

Lahore

单位(医院)：

 Rehmatul-Lil-Alameen Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution 

单位级别：

 三级医院 

Institution
hospital：

Rehmatul-Lil-Alameen Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

Pain

指标类型：

主要指标

Outcome：

Pain

Type：

Primary indicator

测量时间点：

At baseline and at the end of 12 - weeks

测量方法：

WOMAC score

Measure time point of outcome：

At baseline and at the end of 12 - weeks

Measure method：

WOMAC score

指标中文名：

Activities of daily living

指标类型：

主要指标

Outcome：

Activities of daily living

Type：

Primary indicator

测量时间点：

At baseline and at the end of 12 - weeks

测量方法：

Katz index of independence in activities of daily living

Measure time point of outcome：

At baseline and at the end of 12 - weeks

Measure method：

Katz index of independence in activities of daily living

指标中文名：

Mobility

指标类型：

次要指标

Outcome：

Mobility

Type：

Secondary indicator

测量时间点：

At baseline and at the end of 12 - weeks

测量方法：

Timed Up and Go test

Measure time point of outcome：

At baseline and at the end of 12 - weeks

Measure method：

Timed Up and Go test

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 45 岁 years
最大 Max age 60 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）：

Randomization will be done by a computer generated number. After randomization each group will be called separately for their interventions.

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

Randomization will be done by a computer generated number. After randomization each group will be called separately for their interventions.

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：

The principle investigator will not be blinded. The participants receiving the intervention will be blinded by simply not informing them of their treatment allocation.

Blinding：

The principle investigator will not be blinded. The participants receiving the intervention will be blinded by simply not informing them of their treatment allocation.

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

是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）：

Metadata and protocol

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

Metadata and protocol

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：

Data will be collected with the help of questionnaire

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

Data will be collected with the help of questionnaire

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：

  2020-07-10 09:46:39
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