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EFFECT OF PILATES BASED EXERCISES ON SYMPTOMATIC KNEE OSTEOARTHRITIS
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注册号：

Registration number：

 ChiCTR2000030486 

最近更新日期：

Date of Last Refreshed on：

 2020-03-04 11:30:25 

注册时间：

Date of Registration：

 2020-03-03 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

EFFECT OF PILATES BASED EXERCISES ON SYMPTOMATIC KNEE OSTEOARTHRITIS

Public title：

EFFECT OF PILATES BASED EXERCISES ON SYMPTOMATIC KNEE OSTEOARTHRITIS

注册题目简写：

English Acronym：

研究课题的正式科学名称：

EFFECT OF PILATES BASED EXERCISES ON SYMPTOMATIC KNEE OSTEOARTHRITIS

Scientific title：

EFFECT OF PILATES BASED EXERCISES ON SYMPTOMATIC KNEE OSTEOARTHRITIS

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：

Dr. Muhammad Asad Chaudhary 

研究负责人：

Dr. Nadia Saleem 

Applicant：

Dr. Muhammad Asad Chaudhary 

Study leader：

Dr. Nadia Saleem 

申请注册联系人电话：

Applicant telephone：

 +92 30 04706509

研究负责人电话：

Study leader's
telephone：

+92 30 04460846

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：

 asadchaudhary97@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 nadiasaleem256@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：

House No. 76 Street No.1 Main Bazar Gunj Mughalpura, Lahore, Pakistan

研究负责人通讯地址：

12-B Hashmi Garden, Bahawalpur, Pakistan

Applicant address：

House No. 76 Street No.1 Main Bazar Gunj Mughalpura, Lahore, Pakistan

Study leader's address：

12-B Hashmi Garden, Bahawalpur, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 54000

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

巴基斯坦Shalamar Medical and Dental College

Applicant's institution：

Shalamar Medical and Dental College

研究负责人所在单位：

巴基斯坦Riphah International University

Affiliation of the Leader：

Riphah International University

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：

 005089

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：

Ethical Review Committee

Name of the ethic committee：

Ethical Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-04-05 00:00:00

伦理委员会联系人：

Dr Salman Bashir

Contact Name of the ethic committee：

Dr Salman Bashir

伦理委员会联系地址：

Riphah International University, Qauid e Azam Campus Madre Millat Road, Lahore, Pakistan

Contact Address of the ethic committee：

Riphah International University, Qauid e Azam Campus Madre Millat Road, Lahore, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +92 3470118568

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 salmanchisty@gmail.com

研究实施负责（组长）单位：

Nadia Saleem

Primary sponsor：

Nadia Saleem

研究实施负责（组长）单位地址：

12-B Hashmi Garden, Bahawalpur, Pakistan

Primary sponsor's address：

12-B Hashmi Garden, Bahawalpur, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Self Funded

Source(s) of funding：

Self Funded

研究疾病：

膝骨关节炎  

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. To determine the effect of Pilates based exercises on pain in knee osteoarthritis. 2. To determine the effect of Pilates based exercises on functional disability in knee osteoarthritis. 3. To determine the effect of isometric and Pilates exercise on range of motion in knee osteoarthritis.  

Objectives of Study：

1. To determine the effect of Pilates based exercises on pain in knee osteoarthritis. 2. To determine the effect of Pilates based exercises on functional disability in knee osteoarthritis. 3. To determine the effect of isometric and Pilates exercise on range of motion in knee osteoarthritis.

药物成份或治疗方案详述：

Control group protocol (isometrics): 1. Hot pack treatment for 7-10 minutes. TENS for 10 minutes; 2. Quadriceps strengthening and hamstring stretching exercises for 8 weeks; Interventional group protocol (pilates); 1. Hot pack treatment for 7-10 minutes. TENS for 10 minutes; 2. Quadriceps strengthening and hamstring stretching exercises Pilates based exercises for 8 weeks: 2 sessions.week x 8 weeks; 3. Duration: 1 hour (10 minutes as warm up, 40 minutes of pilates exercise and 10 minutes as cooling); 4. Pilates exercise protocol contained postural training, relaxation, stretching, balance, breath and strength training; 5. Quadriceps and glutes strengthening exercises: Bridge, squats with ball, lateral band walk. Stretches to improve flexibility: Hip flexor, Glutes , seated hamstring, quads stretch; 6. Control: single leg squat; 7. In week 1 patients performed Hundred in 5 repetitions and 2 set; 8. In week 2 and 3 patients additionally performed one leg stretch and double leg stretch in 6 repetitions and 2 sets; 9. In week 4 addition of 7 repetitions of clams was made; 10. In week 5,6 further addition of 2 sets of one leg kick was done in exercise program; 11. In week 7 patients additionally performed 8 repetitions of side kicks; In week 8 addition of 10 repetitions of one leg circle was made. 

Description for medicine or protocol of treatment in detail：

Control group protocol (isometrics): 1. Hot pack treatment for 7-10 minutes. TENS for 10 minutes; 2. Quadriceps strengthening and hamstring stretching exercises for 8 weeks; Interventional group protocol (pilates); 1. Hot pack treatment for 7-10 minutes. TENS for 10 minutes; 2. Quadriceps strengthening and hamstring stretching exercises Pilates based exercises for 8 weeks: 2 sessions.week x 8 weeks; 3. Duration: 1 hour (10 minutes as warm up, 40 minutes of pilates exercise and 10 minutes as cooling); 4. Pilates exercise protocol contained postural training, relaxation, stretching, balance, breath and strength training; 5. Quadriceps and glutes strengthening exercises: Bridge, squats with ball, lateral band walk. Stretches to improve flexibility: Hip flexor, Glutes , seated hamstring, quads stretch; 6. Control: single leg squat; 7. In week 1 patients performed Hundred in 5 repetitions and 2 set; 8. In week 2 and 3 patients additionally performed one leg stretch and double leg stretch in 6 repetitions and 2 sets; 9. In week 4 addition of 7 repetitions of clams was made; 10. In week 5,6 further addition of 2 sets of one leg kick was done in exercise program; 11. In week 7 patients additionally performed 8 repetitions of side kicks; In week 8 addition of 10 repetitions of one leg circle was made. 

纳入标准：

Inclusion criteria

排除标准：

1. Past knee surgery e.g. total knee replacement (TKR);
2. Recent Intra articular steroid injection (Past 6 months);
3. Use of Assistive devices disease;
4. Cardio-Respiratory dysfunctions;
5. Any neurological condition affecting lower limbs and balance.

Exclusion criteria：

1. Past knee surgery e.g. total knee replacement (TKR);
2. Recent Intra articular steroid injection (Past 6 months);
3. Use of Assistive devices disease;
4. Cardio-Respiratory dysfunctions;
5. Any neurological condition affecting lower limbs and balance.

研究实施时间：

Study execute time：

从 From 2019-06-28 00:00:00至 To 2019-12-26 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-06-26 00:00:00 至 To 2019-08-01 00:00:00

干预措施：

Interventions：

组别：

Experimental

样本量：

 22

Group：

Experimental

Sample size：

干预措施：

Pilates Based Exercises

干预措施代码：

Intervention：

Pilates Based Exercises

Intervention code：

组别：

Control

样本量：

 22

Group：

Control

Sample size：

干预措施：

Isometrics

干预措施代码：

Intervention：

Isometrics

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)：

 Bahawalpur 

Country：

Pakistan

Province：

Punjab

City：

Bahawalpur

单位(医院)：

 国家医院 

单位级别：

 三级医院 

Institution
hospital：

National Hospital

Level of the institution：

Tertiary care

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：

Pretreatment, 4th week, 8th week

测量方法：

Numeric Pain rating scale

Measure time point of outcome：

Pretreatment, 4th week, 8th week

Measure method：

Numeric Pain rating scale

指标中文名：

Range of Motion

指标类型：

主要指标

Outcome：

Range of Motion

Type：

Primary indicator

测量时间点：

Pretreatment, 4th week, 8th week

测量方法：

Goniometer

Measure time point of outcome：

Pretreatment, 4th week, 8th week

Measure method：

Goniometer

指标中文名：

Functional Ability

指标类型：

主要指标

Outcome：

Functional Ability

Type：

Primary indicator

测量时间点：

Pretreatment, 4th week, 8th week

测量方法：

Western Ontario & Mc Master University Osteoarthritis Index

Measure time point of outcome：

Pretreatment, 4th week, 8th week

Measure method：

Western Ontario & Mc Master University Osteoarthritis Index

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 35 岁 years
最大 Max age 65 岁 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）：

A person not part of the study done randomization using block method

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

A person not part of the study done randomization using block 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：

Statistician, Assessor

Blinding：

Statistician, Assessor

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）：

Available on request at asadchaudhary97@gmail.com

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

Available on request at asadchaudhary97@gmail.com

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：

EFFECT OF PILATES BASED EXERCISES ON SYMPTOMATIC KNEE OSTEOARTHRITIS I am conducting an interventional study on above topic. You are requested to be part of this study, your voluntary participation is highly appreciable and we also learn more about the effectiveness of above mention technique. All data collected from you will be coded in order to protect your identity, and should not be disclosed to anyone. You can with draw from this study any time during the treatment session. Thank you for your cooperation.

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

EFFECT OF PILATES BASED EXERCISES ON SYMPTOMATIC KNEE OSTEOARTHRITIS I am conducting an interventional study on above topic. You are requested to be part of this study, your voluntary participation is highly appreciable and we also learn more about the effectiveness of above mention technique. All data collected from you will be coded in order to protect your identity, and should not be disclosed to anyone. You can with draw from this study any time during the treatment session. Thank you for your cooperation.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-03-04 11:30:25
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