ChiCTR2100044026 版本V1.0 版本创建时间2021/03/06 14:03:44 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：

 ChiCTR2100044026 

最近更新日期：

Date of Last Refreshed on：

 2021-03-06 14:01:20 

注册时间：

Date of Registration：

 2021-03-06 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Effects of high-intensity aerobic training with high protein diet in childhood obesity following COVID-19 infection.

Public title：

Effects of high-intensity aerobic training with high protein diet in childhood obesity following COVID-19 infection.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Clinical (BMI & MRI) and biochemical (Adiponectin, leptin, TNF-α & IL-6) effects of high-intensity aerobic training with high protein diet in childhood obesity following COVID-19 infection.

Scientific title：

Clinical (BMI & MRI) and biochemical (Adiponectin, leptin, TNF-α & IL-6) effects of high-intensity aerobic training with high protein diet in childhood obesity following COVID-19 infection.

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：

Gopal Nambi 

研究负责人：

Gopal Nambi 

Applicant：

Gopal Nambi 

Study leader：

Gopal Nambi 

申请注册联系人电话：

Applicant telephone：

 +96 65 01878382

研究负责人电话：

Study leader's
telephone：

+96 65 01878382

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：

 physio_gopal@rediffmail.com

研究负责人电子邮件：

Study leader's E-mail：

 physio_gopal@rediffmail.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：

Department of physical therapy and health rehabilitation, Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

研究负责人通讯地址：

Department of physical therapy and health rehabilitation, Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

Applicant address：

Department of physical therapy and health rehabilitation, Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

Study leader's address：

Department of physical therapy and health rehabilitation, Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

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：

沙特阿拉伯Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

Applicant's institution：

Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

研究负责人所在单位：

沙特阿拉伯Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

Affiliation of the Leader：

Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

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：

 RHPT/021/015

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：

Department Ethical Committee

Name of the ethic committee：

Department Ethical Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-02-25 00:00:00

伦理委员会联系人：

Dr. Waleed Kamal

Contact Name of the ethic committee：

Dr. Waleed Kamal

伦理委员会联系地址：

Department Ethical Committee, Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

Contact Address of the ethic committee：

Department Ethical Committee, Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

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：

Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

Primary sponsor：

Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

研究实施负责（组长）单位地址：

Department of physical therapy and health rehabilitation, College of applied medical sciences, Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

Primary sponsor's address：

Department of physical therapy and health rehabilitation, College of applied medical sciences, Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

沙特阿拉伯

省(直辖市)：

利雅德

市(区县)：

Al Kharj

Country：

Saudi Arabia

Province：

Riyadh

City：

Al Kharj

单位(医院)：

Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

具体地址：

Department of physical therapy and health rehabilitation, College of applied medical sciences, Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

Institution
hospital：

Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

Address：

Department of physical therapy and health rehabilitation, College of applied medical sciences, Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

经费或物资来源：

Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia

Source(s) of funding：

Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia

研究疾病：

Childhood obesity  

Target disease：

Childhood obesity

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：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To find the clinical and biochemical effects of high-intensity aerobic training with a high protein diet in childhood obesity following COVID-19 infection  

Objectives of Study：

To find the clinical and biochemical effects of high-intensity aerobic training with a high protein diet in childhood obesity following COVID-19 infection

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Positive diagnosis of COVID-19 male children with 5 – 12 years of age was recruited for the study. Body mass index (BMI) between 85th to 99th percentiles was considered for childhood obesity and included in the study.

Inclusion criteria

Positive diagnosis of COVID-19 male children with 5 – 12 years of age was recruited for the study. Body mass index (BMI) between 85th to 99th percentiles was considered for childhood obesity and included in the study.

排除标准：

Subjects with a history of physical training, taking medications, recent surgeries, fractures and joint problems in lower extremity, cardiac and respiratory problems, neurological issues, major psychiatric problems, any other systemic diseases, contraindications for physical training and family with food restrictions were excluded from the study.

Exclusion criteria：

Subjects with a history of physical training, taking medications, recent surgeries, fractures and joint problems in lower extremity, cardiac and respiratory problems, neurological issues, major psychiatric problems, any other systemic diseases, contraindications for physical training and family with food restrictions were excluded from the study.

研究实施时间：

Study execute time：

从 From 2020-03-15 00:00:00至 To 2021-01-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-03-15 00:00:00 至 To 2020-07-15 00:00:00

干预措施：

Interventions：

组别：

A

样本量：

 38

Group：

A

Sample size：

干预措施：

high-intensity aerobic training with high protein diet

干预措施代码：

Intervention：

high-intensity aerobic training with high protein diet

Intervention code：

组别：

B

样本量：

 38

Group：

B

Sample size：

干预措施：

Control

干预措施代码：

Intervention：

Control

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 沙特阿拉伯

省(直辖市)：

 利雅德 

市(区县)：

 Al Kharj 

Country：

Saudi Arabia

Province：

Riyadh

City：

Al Kharj

单位(医院)：

 Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia 

单位级别：

 大学 

Institution
hospital：

Prince sattam bin abdulaziz University, Al Kharj, Saudi Arabia

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Basal metabolic index (BMI)

指标类型：

主要指标

Outcome：

Basal metabolic index (BMI)

Type：

Primary indicator

测量时间点：

baseline, 8th week and at 6 months follow up

测量方法：

Measure time point of outcome：

baseline, 8th week and at 6 months follow up

Measure method：

指标中文名：

muscle mass – cross sectional area CSA) and biochemical (Adiponectin, leptin, TNF-α & IL-6)

指标类型：

次要指标

Outcome：

muscle mass – cross sectional area CSA) and biochemical (Adiponectin, leptin, TNF-α & IL-6)

Type：

Secondary indicator

测量时间点：

baseline, 8th week and at 6 months follow up

测量方法：

Measure time point of outcome：

baseline, 8th week and at 6 months follow up

Measure method：

指标中文名：

muscle mass – cross sectional area CSA) and biochemical (Adiponectin, leptin, TNF-α & IL-6)

指标类型：

次要指标

Outcome：

muscle mass – cross sectional area CSA) and biochemical (Adiponectin, leptin, TNF-α & IL-6)

Type：

Secondary indicator

测量时间点：

baseline, 8th week and at 6 months follow up

测量方法：

Measure time point of outcome：

baseline, 8th week and at 6 months follow up

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood

组织：

Sample Name：

Blood

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 5 岁 years
最大 Max age 12 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）：

A two block simple random sampling method was used to randomize and allocated them into two groups through sealed envelopes. The group A was treated with high-intensity aerobic training with high protein diet (n = 38) and the group B (n = 38) was considered as control group

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

A two block simple random sampling method was used to randomize and allocated them into two groups through sealed envelopes. The group A was treated with high-intensity aerobic training with high protein diet (n = 38) and the group B (n = 38) was considered as control group

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：

Not stated

Blinding：

Not stated

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）：

Through web based database

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

Through web based database

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：

Manual data collection

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

Manual data collection

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-03-06 14:01:20