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Study for the dose-response model and intervention strategy of physical activity for the frail elderly based on SFT
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注册号:

Registration number:

ChiCTR2000031099 

最近更新日期:

Date of Last Refreshed on:

2020-03-22 

注册时间:

Date of Registration:

2020-03-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于SFT的衰弱老年人运动剂量—效应模型及干预策略研究 

Public title:

Study for the dose-response model and intervention strategy of physical activity for the frail elderly based on SFT 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于SFT的衰弱老年人运动剂量—效应模型及干预策略研究 

Scientific title:

Study for the dose-response model and intervention strategy of physical activity for the frail elderly based on SFT 

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:

赖小星 

研究负责人:

赖小星 

Applicant:

Lai XiaoXing 

Study leader:

Lai XiaoXing 

申请注册联系人电话:

Applicant telephone:

+86 13810545829 

研究负责人电话:

Study leader's telephone:

+86 18612672338 

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:

laixx86@163.com 

研究负责人电子邮件:

Study leader's E-mail:

laixx86@163.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:

北京市东城区帅府园1号北京协和医院保健医疗部三层病房 

研究负责人通讯地址:

北京市东城区帅府园1号北京协和医院保健医疗部三层病房 

Applicant address:

1 Shuai-Fu-Yuan, Dongdan, Dongcheng District, Beijing, China 

Study leader's address:

1 Shuai-Fu-Yuan, Dongdan, Dongcheng District, Beijing, 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:

中国医学科学院北京协和医院 

Applicant's institution:

Beijing Union Medical College Hospital,Chinese Academy of Medical Sciences 

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:

JS-2264 

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:

中国医学科学院北京协和医院伦理审查委员会 

Name of the ethic committee:

Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-10 

伦理委员会联系人:

徐辉 

Contact Name of the ethic committee:

1 Shuaifuyuan, Dongcheng District, Beijing, China  

伦理委员会联系地址:

北京市东城区帅府园1号 

Contact Address of the ethic committee:

1 Shuai-Fu-Yuan, Dongdan, Dongcheng District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10-69156874 

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:

中国医学科学院北京协和医院 

Primary sponsor:

Beijing Union Hospital, Chinese Academy of Medical Sciences 

研究实施负责(组长)单位地址:

北京市东城区帅府园1号 

Primary sponsor's address:

1 Shuai-Fu-Yuan, Dongdan, Dongcheng District, Beijing, 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国医学科学院北京协和医院

具体地址:

北京市东城区帅府园1号

Institution
hospital:

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Address:

1 Shuai-Fu-Yuan, Dongdan, Dongcheng District

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation 

研究疾病:

衰弱老年人 

Target disease:

Asthenia; frail elderly 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本研究通过设计合理的运动剂量干预方法,探讨量和强度对衰弱老年人肌肉质量、体适能、活动及睡眠的影响,解释哪种运动因素更有利于结局的改善,绘制运动剂量与各效应指标的反应曲线,构建并验证衰弱老年人运动剂量—效应模型,确定值得推广的衰弱老年人运动剂量的阈值,评价体适能测试(Senior Fitness Test, SFT)在衰弱老年人运动效应指标的适用性,为老年人的运动干预提供证据,为制定老年人运动健康政策提供研究基础。 

Objectives of Study:

This current study designs a reasonable exercise dose intervention method, to explore the effects of exercise volume and intensity on muscle quality, physical fitness activity ability and sleep of the frail elderly, and to explain which exercise factor is more conducive to improving outcomes of frail elderly. The study aims to draw the response curves of exercise dose and effect indexes, construct and validate the exercise dose-effect model for the frail elderly, determine the propagable threshold of exercise dose for the frail elderly, and to evaluate the applicability of Senior Fitness Test in the exercise effect for the frail elderly. Meanwhile the current study aims to provide evidence for physical activity for in the frail elderly and provide research basis for formulating sports health policy for the elderly. 

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:

①自愿参加本研究,并签署书面知情同意书 ②年龄≥60岁 ③符合Fried衰弱诊断的标准 

Inclusion criteria

1. Patients who voluntarily participated in the study and signed a written informed consent; 2. Aged >=60 years; 3. Patients who meet the criteria of Fried's asthenia diagnosis. 

排除标准:

①简易精神状态评价量表(MMSE)得分<27分,认知障碍 ②患有高血压、糖尿病、不稳定型心血管疾病、神经肌肉疾病、骨骼肌肉畸形、有症状的类风湿关节炎、深静脉血栓形成 ③进行规律性体力活动(以一周不超过3次,每次为30min为标准) ④近期手术(1个月内) ⑤营养摄入量突然减少,日摄入量<1600 kcal 

Exclusion criteria:

1. Patients with MMSE score < 27 and cognitive impairment; 2. Patients with hypertension, diabetes, unstable cardiovascular disease, neuromuscular disease, skeletal muscle malformation, symptomatic rheumatoid arthritis, deep vein thrombosis; 3. Patients with regular physical activity (no more than 3 times a week, 30 minutes each time as the standard); 4. Patients with recent surgery (within 1 month); 5. Patients with a sudden decrease in nutritional intake and a daily intake of < 1600 kcal. 

研究实施时间:

Study execute time:

From2020-03-10To 2022-12-31 

干预措施:

Interventions:

组别:

1

样本量:

60

Group:

1

Sample size:

干预措施:

中量小强度膝伸肌抗阻训练

干预措施代码:

Intervention:

Middle and low strength knee extensor resistance training

Intervention code:

组别:

2

样本量:

60

Group:

2

Sample size:

干预措施:

中量中强度膝伸肌抗阻训练

干预措施代码:

Intervention:

Middle quantity and strength knee extensor resistance training

Intervention code:

组别:

3

样本量:

60

Group:

3

Sample size:

干预措施:

中量大强度膝伸肌抗阻训练

干预措施代码:

Intervention:

Middle and high strength knee extensor resistance training

Intervention code:

组别:

4

样本量:

60

Group:

4

Sample size:

干预措施:

大量小强度膝伸肌抗阻训练

干预措施代码:

Intervention:

Large and low strength knee extensor resistance training

Intervention code:

组别:

5

样本量:

60

Group:

5

Sample size:

干预措施:

大量中强度膝伸肌抗阻训练

干预措施代码:

Intervention:

Large and middle strength knee extensor resistance training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

养老机构 

单位级别:

 

Institution
hospital:

Nursing home  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

肌肉力量

指标类型:

主要指标 

Outcome:

Muscle strength

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌肉耐力

指标类型:

主要指标 

Outcome:

Muscle Endurance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体适能

指标类型:

次要指标 

Outcome:

Physical fitness

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

活动能力

指标类型:

次要指标 

Outcome:

Activity ability

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

代谢情况

指标类型:

附加指标 

Outcome:

Metabolic state

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡眠状况

指标类型:

附加指标 

Outcome:

Sleep status

Type:

Additional 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 years
最大 Max age 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):

随机数字表法

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

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:

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):

暂未确定

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

Not yet determined

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:

暂未确定

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

Not yet determined

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-03-22
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