中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR1800016599
最近更新日期： Date of Last Refreshed on：	2018-06-12 00:35:10
注册时间： Date of Registration：	2018-06-11 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	伴有代谢综合征II型糖尿病老年人力量训练：一个随机，双盲，伪对照纵向试验
Public title：	Power Training in Older Type 2 Diabetics with Metabolic Syndrome: A Randomised, Double Blind, Sham Controlled, Longitudinal Trial
注册题目简写：	REPEAT 2 DO
English Acronym：	REPEAT 2 DO
研究课题的正式科学名称：	伴有代谢综合征II型糖尿病老年人和力量训练
Scientific title：	Power Training and Older Type 2 Diabetics with Metabolic Syndrome
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：	REN RU ZHAO	研究负责人：	REN RU ZHAO
Applicant：	REN RU ZHAO	Study leader：	REN RU ZHAO
申请注册联系人电话： Applicant telephone：	+86 0597-3305523	研究负责人电话： Study leader's telephone：	+86 0597-3305523
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：	rzha6475@uni.sydney.edu.au	研究负责人电子邮件： Study leader's E-mail：	rzha6475@uni.sydney.edu.au
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：	福建省龙岩市东肖北路1号	研究负责人通讯地址：	福建省龙岩市东肖北路1号
Applicant address：	1 Dongxiao Road North, Longyan, Fujian, China	Study leader's address：	1 Dongxiao Road North, Longyan, Fujian, China
申请注册联系人邮政编码： Applicant postcode：	364012	研究负责人邮政编码： Study leader's postcode：	364012
申请人所在单位：	龙岩学院
Applicant's institution：	The University of Longyan
研究负责人所在单位：	龙岩学院
Affiliation of the Leader：	The University of Longyan

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：	2008-001	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：	龙岩人民医院医学伦理委员会
Name of the ethic committee：	Longyan Renmin Hospital Medical Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2013-08-26 00:00:00
伦理委员会联系人：	曾丽红
Contact Name of the ethic committee：	Lihong Zeng
伦理委员会联系地址：	福建省龙岩市登高西路31号
Contact Address of the ethic committee：	31 Denggao Road West, Longyan City, Fujian, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 13599609088	伦理委员会联系人邮箱： Contact email of the ethic committee：	lyrmyykjk@163.com

研究实施负责（组长）单位：

龙岩学院

Primary sponsor：

University of Longyan

研究实施负责（组长）单位地址：

福建省龙岩市东肖北路1号

Primary sponsor's address：

1 Dongxiao Road North, Longyan, Fujian, 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)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：	Longyan
单位(医院)：	人民医院	具体地址：	龙岩市登高西路31号
Institution hospital：	Renmin Hospital	Address：	31 West Denggao Road

国家：	中国	省(直辖市)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	新罗区人民政府	具体地址：	福建省龙岩市新罗区龙川东路45号
Institution hospital：	Xinluo People's Government	Address：	45 Longchuan Road East

经费或物资来源：

龙岩学院，龙岩市新罗区人民政府，福建省海外高层次人才和龙岩人民医院基金

Source(s) of funding：

The University of Longyan, Longyan Xinluo Peoples' Government, Fujian Overseas High-level Talents, and Longyan Renmin Hospital

研究疾病：

II型糖尿病和它的并发症

Target disease：

Type 2 Diabetes and associated with complications

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：

III期临床试验

Study phase：

3

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

我们的具体目标是进行为期12个月的随机对照试验(RCT)，测试II型糖尿病和代谢综合征老年患者力量训练和常规医疗保健的有效性。此外，我们将评估这种类型的运动在6年跟踪可行性和益处

Objectives of Study：

Our specific aim was to conduct a 12-month randomized controlled trial (RCT) to test the efficacy of power training added to the usual medical care of older adults with type 2 diabetes and metabolic syndrome. In addition, the long-term feasibility and benefits of this type of exercise will be assessed over 6 years of follow-up.

药物成份或治疗方案详述：

实验干预方案：实验参与者在研究人员的监督下，每周3天接受8大肌群的高强度力量训练，使用气动阻力设备(Keiser运动健康设备公司)。(美国加利福尼亚州弗雷斯诺)所有培训人员都是澳大利亚运动和运动科学专业的运动生理学家、其他在运动和慢性病治疗方面具有专门知识的相关卫生专业人员，或者是龙岩大学的运动生理学研究生。所有的锻炼都在诊所进行监督，并由现场和场外医生通过每周的病例会议进行监督。练习的目标是手臂、腿部和躯干的大型对称肌肉群：坐姿双臂划船、坐姿推胸、坐姿腿屈伸、坐姿腿举、站姿左腿直腿侧平举、站姿右腿直腿侧平举、髋关节屈曲、髋关节背伸展。采用了一种称为力量训练的渐进式阻力训练，该训练尽可能快地进行向心收缩(举升)，而4秒慢速完成离心收缩用。在每次练习中，参与者进行3组8次重复(每条腿2组8次髋关节屈曲、髋关节伸展和髋关节外展)。强度设定为最近确定的1次最大重复举起的重量(1RM)的80%，每4周重新评估一次。在1Rm测试不可行的情况下，针对15~18岁之间感知用力的Borg量表评分。伪对照组组在同一设备上训练，每周3次，在同一训练者的监督下，在一天的不同时间进行训练，以便对研究者的假设视而不见，这两种干预措施都具有潜在的益处。这些参与者在同一台机器上进行了3组8次重复，但没有超过机器杆的负荷，使用1-2秒的向心和离心收缩速度。没有临时的1RM测试，也没有进展。该方案已被证明在肌肉功能或质量、功能状态、活动能力、抑郁、有氧能力或其他临床结果方面的变化最小。

Description for medicine or protocol of treatment in detail：

Experiment intervention protocol: power training Experimental participants received high intensity power training of 8 major muscle groups 3 days per week under the supervision of research staff, using pneumatic resistance equipment (Keiser Sports Health Equipment, Inc. Fresno, CA). All trainers were Exercise and Sport Science Australia approved exercise physiologists, other allied health professionals with expertise in exercise and chronic disease treatment, or postgraduate students in exercise physiology at the University of Longyan. All exercise was supervised in the clinic/gym and overseen by onsite and offsite physicians via weekly case conferences. The exercises targeted large symmetrical muscle groups of the arms, legs, and trunk: seated row, chest press, leg press, knee extension, hip flexion, hip extension and hip abduction. A version of progressive resistance training known as power training was employed, in which the concentric contraction (lifting) was done as quickly as possible, while the eccentric contraction (lowering) was done over 4 seconds. For each exercise, participants performed 3 sets of 8 repetitions (2 sets of 8 on each leg for hip flexion, hip extension and hip abduction). The intensity was set at 80% of the most recently determined 1 repetition maximum (1RM), re-assessed every 4 weeks. Where 1RM testing was not feasible, resistances were increased by targeting a Borg scale rating of perceived exertion between 15 and 18. Control group intervention: SHAM The SHAM exercise group trained on the same equipment, 3 times a week, under supervision from the same trainers at different times of the day so as to remain blinded to the investigator's hypotheses, with both interventions offered as potentially beneficial. These participants performed 3 sets of 8 repetitions on the same machines, but with no loading beyond the bar of the machine, using 1-2 second concentric and eccentric contraction speed. No interim 1RM testing and no progression took place. This regimen has been shown to produce minimal change in muscle function or mass, functional status, mobility, depression, aerobic capacity, or other clinical outcomes.

纳入标准：

Inclusion criteria

Inclusionary criteria were based on diagnosed type 2 diabetes, age, and physical activity level. Participants had to be over 60 years old and sedentary (no progressive resistance training; structured exercise ≤ 1/week; less than 150min/week low or moderate-intensity walking or other aerobic exercises).  Participants could be treated with diet alone, oral medications or insulin or combination at the time of enrolment.
Metabolic syndrome was defined according to the International Diabetes Federation as:
Central obesity (defined as waist circumference ≥ 90 cm for Chinese men and ≥ 80 cm for Chinese women, plus any 2 of the following 4 factors:
* Raised TG level: ≥ 1.7 mmol/L, or specific treatment for this lipid abnormality;
* Reduced HDL cholesterol: < 1.03 mmol/L) in men or < 1.29 mmol/L in women, or specific treatment for this lipid abnormality;
* Raised resting blood pressure: systolic blood pressure (BP) ≥ 130 mmHg or diastolic BP ≥85 mmHg, or treatment of previously diagnosed hypertension;
* Raised fasting plasma glucose (FPG) ≥ 5.6 mmol/L, or previously diagnosed T2D.

排除标准：

排除标准包括明显的认知功能障碍、非卧床状态或下肢截肢，而非脚趾、当前酒精或药物滥用、由于旅行计划或其他承诺而不能遵守一年中的研究要求，以及抵抗训练运动的特定禁忌症，例如不稳定的心血管疾病、未修复的主动脉瘤、症状性疝、增生性糖尿病性视网膜病或快速进行性或晚期疾病。研究入组和筛选程序之前，解决了暂时排除（过去3个月内的糖尿病药物或任何剂量变化、6周内的视网膜激光手术、不受控制的高血压）。

Exclusion criteria：

Exclusionary criteria included significant cognitive impairment, non-ambulatory status or lower extremity amputation other than toes, current alcohol or substance abuse, inability to comply with study requirements over the course of one year due to travel plans or other commitments, and specific contraindications to resistance training exercise, such as unstable cardiovascular disease, unrepaired aortic aneurysm, symptomatic hernias, proliferative diabetic retinopathy, or rapidly progressive or terminal illness. Temporary exclusions (any change in dosage or type of diabetic medications within the past 3 months, retinal laser surgery within 6 weeks, uncontrolled hypertension) were resolved prior to study enrolment and screening procedure.

研究实施时间：

Study execute time：

从 From 2019-01-01 00:00:00至 To 2022-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2018-09-01 00:00:00 至 To 2021-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	60
Group：	Experimental Intervention	Sample size：	60
干预措施：	力量训练	干预措施代码：
Intervention：	Power Training	Intervention code：

组别：	对照组	样本量：	60
Group：	Control group	Sample size：	60
干预措施：	SHAM	干预措施代码：
Intervention：	Control group intervention	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：	Longyan
单位(医院)：	龙岩学院	单位级别：	学院
Institution hospital：	University of Longyan	Level of the institution：	University

国家：	中国	省(直辖市)：	福建	市(区县)：	龙岩
Country：	China	Province：	Fujian	City：	Longyan
单位(医院)：	人民医院	单位级别：	三甲医院
Institution hospital：	Renmin Hospital	Level of the institution：	Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：	Insulin Sensitivity, Glucose Homeostasis	指标类型：	主要指标
Outcome：	Insulin Sensitivity, Glucose Homeostasis	Type：	Primary indicator
测量时间点：	Baseline, 6 months, and 12 months	测量方法：
Measure time point of outcome：	Baseline, 6 months, and 12 months	Measure method：

指标中文名：	Cardiovascular Health, Lipid Metabolism, Muscle Metabolism, Adipokines, Inflammatory Markers, Body Composition, Exercise Capacity and Functional Status, Neuropsychological Profile, Health-Related Quality of Life, Nutritional Intake, Energy Expenditurey and Actigraph accelerometers, Brain structure, biochemistry, and function.	指标类型：	次要指标
Outcome：	Cardiovascular Health, Lipid Metabolism, Muscle Metabolism, Adipokines, Inflammatory Markers, Body Composition, Exercise Capacity and Functional Status, Neuropsychological Profile, Health-Related Quality of Life, Nutritional Intake, Energy Expenditurey and Actigraph accelerometers, Brain structure, biochemistry, and function.	Type：	Secondary indicator
测量时间点：	Baseline, 6 months, and 12 months	测量方法：
Measure time point of outcome：	Baseline, 6 months, and 12 months	Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：	皮下脂肪和肌肉组织
Sample Name：	Blood	Tissue：	Subcutaneous adipose and muscle tissue
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	唾液	组织：
Sample Name：	Saliva	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	60	岁 years
最大 Max age	85	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）：

一个计算机化的随机数发生器(http：/www.acuization.com，由塔夫茨大学杰拉德·达拉尔博士创建)被用来随机化符合条件的参与者，按性别和胰岛素的使用分为四组。随机化发生在整个基线完成时。

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

A computerized random-number generator (http://www.randomization.com, created by Dr Gerard E. Dallal, Tufts University) was used to randomize eligible participants at the level of the individual participant, stratified by sex and use of insulin, in blocks of four. Randomization occurs at the completion of the entire ba

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：	招募人员分配参与者到两个治疗组的一个，研究人员被盲研究对象在那一干预组。在12个月的研究中，所有小组都将有相同的数量和频率与培训师联系。盲评者在不同的时间获得和分析所有的主要和次要结果。
Blinding：	Subjects are informed that they will be randomly assigned to one of two treatment groups by the recruitment officer, and will be blinded to the investigator's hypothesis as to which is the preferred intervention arm. All groups will have an equal volume and frequency of contact with trainers over the 12 months of the study. All primary and secondary outcomes will be obtained and analyzed by blinded assessors on different days to the training programs.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	电子数据采集系统
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Electronic Data Capture System
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：	电子数据采集系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Electronic Data Capture System
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2018-06-12 00:35:10