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Effect of home-based individual aerobic combined with resistance exercise on physical fitness level and cardiovascular function in elderly with sarcopenia
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注册号:

Registration number:

ChiCTR1900027960 

最近更新日期:

Date of Last Refreshed on:

2019-12-07 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

个体化居家运动锻炼对肌少症人群体能水平及心血管功能的干预研究 

Public title:

Effect of home-based individual aerobic combined with resistance exercise on physical fitness level and cardiovascular function in elderly with sarcopenia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

个体化居家运动锻炼对肌少症人群体能水平及心血管功能的干预研究 

Scientific title:

Effect of home-based individual aerobic combined with resistance exercise on physical fitness level and cardiovascular function in elderly with sarcopenia 

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:

黎梦丽 

研究负责人:

王丽 

Applicant:

Mengli Li 

Study leader:

Li Wang 

申请注册联系人电话:

Applicant telephone:

+86 18351075005 

研究负责人电话:

Study leader's telephone:

+86 15862376628 

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:

lmlsuda@163.com 

研究负责人电子邮件:

Study leader's E-mail:

li-wang-1@suda.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:

江苏省苏州市十梓街1号 

研究负责人通讯地址:

江苏省苏州市十梓街1号 

Applicant address:

1 Shizi Street, Suzhou, Jiangsu, China 

Study leader's address:

1 Shizi Street, Suzhou, Jiangsu, China 

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:

苏州大学医学部护理学院 

Applicant's institution:

School of Nursing, Medical Department of Soochow 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:

ECSU-2019000161 

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:

苏州大学伦理委员会 

Name of the ethic committee:

Ethics Committee of Soochow University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-13 

伦理委员会联系人:

徐广银 

Contact Name of the ethic committee:

Guangyin Xu 

伦理委员会联系地址:

江苏省苏州市十梓街1号 

Contact Address of the ethic committee:

1 Shizi Street, Suzhou, Jiangsu, China 

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:

苏州大学医学部护理学院 

Primary sponsor:

School of nursing, Medical Department of Soochow University 

研究实施负责(组长)单位地址:

江苏省苏州市十梓街1号 

Primary sponsor's address:

1 Shizi Street, Suzhou, Jiangsu, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏

市(区县):

苏州

Country:

Chnia

Province:

Jiangsu

City:

Suzhou

单位(医院):

苏州大学

具体地址:

江苏省苏州市十梓街1号

Institution
hospital:

Soochow University

Address:

1 Shizi Street, Suzhou, Jiangsu, China

经费或物资来源:

政府 

Source(s) of funding:

Government 

研究疾病:

肌少症 

Target disease:

Sarcopenia 

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:

1.了解肌少症人群的体能水平,分析多种不同因素下肌少症人群体能水平的差别; 2.了解肌少症人群的心血管健康状况,分析不同影响因素下心血管健康状况的差异; 3.探索个体化有氧联合抗阻的居家运动对肌少症人群体能水平及心血管健康状况的干预效果,以期为肌少症人群运动方案制定和疾病预防提供科学的参考依据。 

Objectives of Study:

1. Understand the physical fitness level of people with sarcoma and analyze the difference in the physical fitness level under a variety of different factors; 2. Understand the cardiovascular health status of people with sarcopenia, and analyze the differences in cardiovascular health status under different influencing factors; 3. Exploring the intervention effect of individualized aerobic combined resistance home exercise on the physical fitness level and cardiovascular health status of people with sarcopenia, in order to providing scientific reference for the formulation of sports programs and disease prevention of sarcopenia. 

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:

第一部分及第二部分研究: (1)年龄≥60岁; (2)知情同意,自愿加入本研究。 第三部分研究: (1)年龄≥60岁; (2)符合肌少症亚洲工作组肌少症诊断标准; (3)自愿参加并配合研究。 

Inclusion criteria

The first part and the second part study: (1) Aged >=60 years; (2) Informed consent, voluntarily joined the study. The third part of the study: (1) Aged >=60 years; (2) Meet the diagnostic criteria for sarcopenia of the Asian working group of sarcopenia; (3) Voluntarily participate in and cooperate with the research. 

排除标准:

第一部分研究: (1)存在行走困难,如严重的膝骨关节炎、下肢手术等; (2)存在严重身体疾病,如严重的心肝肾功能不全、不可控制的高血压等; (3)存在精神疾病、伴有理解困难,沟通障碍; (4)其他研究者认为不适宜参加本研究。 第二部分研究: 在第一部分的基础上,排除存在严重的心血管疾病或处于急性期,如急性心梗、急性心衰、房室传导阻滞、支架植入术后等。 第三部分研究: (1)已参加某种规律性运动训练(即每周≥3次的中等强度运动); (2)存在运动禁忌症:如严重的骨骼肌肉疾患和心、肺、肝、肾等严重疾病;有脊柱神经损伤或损伤史;严重哮喘,严重骨质疏松等; (3)既往有精神疾病史,或有理解、听觉、视觉障碍,无法正常沟通; 

Exclusion criteria:

The first part of the study: (1) Difficulty walking, such as severe knee osteoarthritis, lower limb surgery, etc .; (2) There are serious physical diseases, such as severe heart, liver and kidney dysfunction, uncontrollable hypertension, etc .; (3) Existence of mental illness, difficulty in understanding, and communication difficulties; (4) Other researchers did not consider it appropriate to participate in this study. The second part of the study: On the basis of the first part, severe cardiovascular disease or acute phase, such as acute myocardial infarction, acute heart failure, atrioventricular block, and stent implantation were excluded. The third part of the study: (1) Have participated in some regular exercise training (that is, moderate intensity exercise >=3 times a week); (2) Contraindications to exercise: such as severe musculoskeletal disorders and serious diseases such as heart, lung, liver, and kidney; history of spinal nerve injury or injury; severe asthma, severe osteoporosis; (3) have a history of mental illness, or have difficulty understanding, hearing, or vision, and cannot communicate normally. 

研究实施时间:

Study execute time:

From2019-09-01To 2022-09-30 

干预措施:

Interventions:

组别:

2组

样本量:

110

Group:

Group 2

Sample size:

干预措施:

居家运动训练

干预措施代码:

Intervention:

Home exercise training

Intervention code:

组别:

1组

样本量:

110

Group:

Group 1

Sample size:

干预措施:

空白

干预措施代码:

Intervention:

Blank

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

苏州 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏州大学本部周围社区 

单位级别:

社区医院 

Institution
hospital:

The coummunities around the headquarters of Soochow University  

Level of the institution:

Community Health Service Center 

测量指标:

Outcomes:

指标中文名:

6分钟步行距离

指标类型:

主要指标 

Outcome:

6 minutes walking distance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脉搏波传导速度

指标类型:

主要指标 

Outcome:

Pulse wave volecity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30秒连续坐椅次数

指标类型:

主要指标 

Outcome:

Number of consecutive seats in 30 seconds

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

握力

指标类型:

次要指标 

Outcome:

Grip 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:

肱二头肌屈举测试

指标类型:

次要指标 

Outcome:

Arm curl test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易肌力测试

指标类型:

次要指标 

Outcome:

Simple muscle test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

柔韧性

指标类型:

次要指标 

Outcome:

Flexibility

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

闭眼单腿站立时间

指标类型:

次要指标 

Outcome:

One Leg Sand with Eyes Closed

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

起立步行计时测试

指标类型:

次要指标 

Outcome:

Time Up and Go Test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Frail衰弱问卷

指标类型:

次要指标 

Outcome:

Frail questionnaire

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动摄氧量

指标类型:

次要指标 

Outcome:

Exercise oxygen uptake

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SF-36量表

指标类型:

次要指标 

Outcome:

SF-36 scale

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:

No

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

由不了解本课题的研究人员,通过随机数字表法,将符合纳入排除标准的受试者分为空白对照组与运动干预组

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

Researchers who do not understand this subject will be divided into blank control group and exercise intervention group by random number table method.

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

实验完成后6个月内公开

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

within six months after the trial complete

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:

采用向伦理委员会索取的方法,可在发表论文后索要数据。

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

Asking organization ethic cimmittee for original data after publication.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-12-07
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