ChiCTR2500097687 版本V1.0 版本创建时间2025/02/24 15:42:19 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：

ChiCTR2500097687 

最近更新日期：

Date of Last Refreshed on：

2025-02-24 15:41:52 

注册时间：

Date of Registration：

2025-02-24 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

上肢等长运动联合血流限制训练促进自体动静脉内瘘成熟的研究

Public title：

The study of isometric upper limb exercise combined with blood flow restriction training to promote the maturation of autologous arteriovenous fistula

注册题目简写：

English Acronym：

研究课题的正式科学名称：

上肢等长运动联合血流限制训练促进动静脉内瘘成熟的研究

Scientific title：

The study of isometric upper limb exercise combined with blood flow restriction training to promote the maturation of autologous arteriovenous fistula

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：

陈明月 

研究负责人：

陈明月 

Applicant：

MingYue Chen 

Study leader：

MingYue Chen 

申请注册联系人电话：

Applicant telephone：

+86 150 0137 2395

研究负责人电话：

Study leader's telephone：

+86 150 0137 2395

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：

m15001372395@163.com

研究负责人电子邮件：

Study leader's E-mail：

m15001372395@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：

北京市西城区长椿街45号

研究负责人通讯地址：

北京市西城区长椿街45号

Applicant address：

45 Changchun Street, Xicheng District, Beijing

Study leader's address：

45 Changchun Street, Xicheng District, Beijing

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：

首都医科大学宣武医院

Applicant's institution：

Xuanwu Hospital, Capital Medical University

研究负责人所在单位：

首都医科大学宣武医院

Affiliation of the Leader：

Xuanwu Hospital, Capital Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

临研审[2024]079号-002

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：

首都医科大学宣武医院伦理委员会

Name of the ethic committee：

Ethics Committee of Xuanwu Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-10-09 00:00:00

伦理委员会联系人：

王威

Contact Name of the ethic committee：

Wei Wang

伦理委员会联系地址：

北京市西城区长椿街45号

Contact Address of the ethic committee：

45 Changchun Street, Xicheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8319 9270

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：

首都医科大学宣武医院

Primary sponsor：

Xuanwu Hospital, Capital Medical University

研究实施负责（组长）单位地址：

北京市西城区长椿街45号

Primary sponsor's address：

45 Changchun Street, Xicheng District, Beijing

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)：

首都医科大学宣武医院

具体地址：

北京市西城区长椿街45号

Institution
hospital：

Xuanwu Hospital, Capital Medical University

Address：

45 Changchun Street, Xicheng District, Beijing

经费或物资来源：

首都医科大学宣武医院2023年护理专项课题

Source(s) of funding：

2023 Nursing project of Xuanwu Hospital, Capital Medical University

Target disease：

Chronic kidney disease stage 4-5

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究的主要目的是与常规的等长运动比较，评估上肢等长运动联合血流限制训练对首次行自体动静脉内瘘手术患者内瘘成熟的有效性。  

Objectives of Study：

The main objective of this study was to evaluate the effectiveness of upper limb isometric exercise combined with blood flow restriction training on the maturation of internal fistula in patients undergoing autogenous internal arteriovenous fistula surgery for the first time, compared with conventional isometric exercise.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1: 获得知情同意 2: 年龄≥18岁 3: 首次行上肢AVF术 4: 内瘘手术为前臂腕部头静脉－桡动脉端侧吻合方式 5: 均由同一手术组医生完成 6: 认知力、理解力、沟通能力良好且能自主运动锻炼 7: 患者及家属配合良好

Inclusion criteria

1: Obtain informed consent 2: Age >=18 years old 3: Upper extremity AVF was performed for the first time 4: The internal fistula operation was the end-to-side anastomosis of the head vein and radial artery of the forearm wrist 5: All were performed by the same surgical team 6: Good cognition, understanding, communication skills and independent exercise 7: Patient and family members cooperate well

排除标准：

1: 高/低血压、心脏疾病、上肢不自主活动者 2: 上肢骨折或骨折未愈合者 3: 术后出现血管血栓、狭窄者

Exclusion criteria：

1: High/low blood pressure, heart disease, upper limb involuntary movement 2: Upper limb fracture or fracture is not healed 3: Postoperative blood vessel thrombosis, stenosis

研究实施时间：

Study execute time：

从 From 2024-10-18 00:00:00至 To 2025-08-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-10-24 00:00:00 至 To 2025-08-01 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

105

Group：

the study group

Sample size：

干预措施：

物理治疗干预方法： 第一阶段的上肢等长运动锻炼（术后 12-72h）、第二阶段的等长运动锻炼（术后 4-30d）、血流限制训练（术后 8-30d）。 物理治疗干预频率： 血流限制训练操作方法：分别于每日上午、下午、晚上使用奥姆龙血压计在患者安静 30 分钟后重复测量非瘘侧肢体上臂血压 3 次后取平均值为实时的测量血压，记录收缩压的数值；使用苏械注准苏械注准 20152070945 可量化充气型医用血压计对瘘侧肢体进行加压，血压计袖带下缘位于吻合口上 20cm 处，关闭加压球囊阀门进行加压充气至 40%收缩压的刻度处，持续关闭球囊阀门 5 分钟以保持水银柱平稳，按照 4 组/60 次（即 30~10~10~10 次），上午加压 30 次，下午加压 20 次同时进行对应的等长运动锻炼，在锻炼的过程中出现水银柱下降的情况，及时再次用球囊进行充气至相应刻度处，晚上加压 10次， 每次加压 5 分钟，间歇放松时间 1 分钟，组间间歇 2 小时，每日锻炼时间累积 6 小时，为期 4 周，3 天/周，共持续 12 天的训练。

干预措施代码：

Intervention：

Intervention methods of physical therapy: upper limb isometric exercise in the first stage (12-72h after surgery), isometric exercise in the second stage (4-30d after surgery), blood flow restriction training (8-30d after surgery) . Frequency of physical therapy intervention: blood flow restriction training Operation method: Omron sphygmomanometer was used in the morning, afternoon and evening of each day to measure the blood pressure of the upper arm of the non-fistula limb for three times after the patient was quiet for 30 minutes, and then the average value was taken as real-time blood pressure measurement and the systolic blood pressure value was recorded. A quantifiable inflatable medical sphygmomanometer (20152070945) was used to pressurize the limb of the fistula side. The lower edge of the cuff of the sphygmomanometer was located 20cm above the anastomotic opening. The valve of the pressure balloon was closed for pressure inflation to the scale of 40% systolic pressure, and the valve of the balloon was closed continuously for 5 minutes to keep the mercury column stable. According to 4 groups /60 times (that is, 30~10~10~10 times), pressure 30 times in the morning, pressure 20 times in the afternoon, while the corresponding isometric exercise exercise, in the process of exercise, the mercury column drops, in time to use the balloon to inflate to the corresponding scale, pressure 10 times in the evening, each pressure for 5 minutes. The interval relaxation time was 1 minute, the interval between the groups was 2 hours, and the daily exercise time was 6 hours, which lasted for 4 weeks, 3 days/week, and a total of 12 days of training·

Intervention code：

组别：

对照组

样本量：

105

Group：

the control group

Sample size：

干预措施：

物理治疗干预方法： 第一阶段的上肢等长运动锻炼（术后 12-72h）、第二阶段的等长运动锻炼（术后 4-30d）. 物理治疗干预频率： 第一阶段锻炼：术后 12-72h. 术后[12，24]h，前臂悬吊保持与上臂垂直。指尖（加压 3s-放松3s）、手指（内收 3s-外展 3s）。术后(24，48]h，仍保持前臂悬吊与上臂垂直，指尖（加压 3s-放松3s）、手指（内收 3s-外展 3s）、旋前旋转拳头锻炼。术后(48，72]h，前臂前伸悬空或放置台面，指尖（加压 3s-放松3s）、手指（内收 3s-外展 3s）、旋前旋转拳头锻炼、挤压橡胶球锻炼、手掌施加压力锻炼。第二阶段锻炼：术后 4-30 天术后[4，7]天，第一阶段锻炼+加压夹训练、手指长度挤压、用拳头施压锻炼。术后[8，30]天，第一阶段锻炼+加压夹训练、手指长度指压、用拳头施压锻炼、1kg 重的屈肌伸展。

干预措施代码：

Intervention：

Physical therapy intervention methods: upper limb isometric exercise in the first stage (12-72h after surgery) and isometric exercise in the second stage (4-30d after surgery). Physical therapy intervention frequency: First stage exercise: 12-72h after surgery. [12,24]h after surgery, the forearm suspension was kept perpendicular to the upper arm. Fingertip (compression 3s- relaxation 3s), finger (adduction 3s- abduction 3s). After operation (24,48) h, the forearm suspension was kept perpendicular to the upper arm, fingertip (compression 3s-release 3s), finger (adduction 3s-abduction 3s), and fist rotation exercises were performed. After surgery (48,72) h, the forearm was suspended forward or placed on the table, fingertip (pressure 3s-release 3s), finger (adduction 3s-abduction 3s), fist rotation exercise, rubber ball compression exercise, palm pressure exercise. The second stage of exercise: 4-30 days after surgery [4,7] days after surgery, the first stage of exercise + pressure clamp training, finger length squeeze, pressure exercise with fists. [8,30] days after surgery, the first phase of exercise + pressure clamp training, finger length shiatsu, fist pressure exercise, 1kg flexor extension.

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)：

首都医科大学宣武医院 

单位级别：

三甲 

Institution
hospital：

Xuanwu Hospital, Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

吻合口处自然血流量

指标类型：

主要指标

Outcome：

Natural blood flow to the anastomosis

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

瘘口处震颤、杂音、抬臂试验、搏动增强试验

指标类型：

次要指标

Outcome：

Autologous arteriovenous fistula tremor, noise, arm lift test, pulsation enhancement 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：

吻合口处出血情况

指标类型：

副作用指标

Outcome：

Bleeding at the anastomosis

Type：

Adverse events

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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

分层随机：由科研团队外的人员产生和保存随机分配序列，将研究对象按照年龄（≥60岁和<60岁）进行分层，按照1:1进行样本量的分配，层内使用R Studio软件及R代码、R函数产生分层随机数字分为实验组和对照组。

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

The random assignment sequence was generated and saved by personnel outside the scientific research team. The subjects were stratified according to age (>=60 years old and <60 years old), and the sample size was allocated according to 1:1. The stratified random numbers were divided into experimental group and control group using R Studio software, R code and R function.

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：

双盲，对受试者和研究者设盲。

Blinding：

Double blind, blinding both subjects and researchers.

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

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）：

数据共享的时间点：2026年08月，数据共享持续时间：2年，数据共享内容：主要指标及相关数据。采用网络平台进行共享：中国知网、www.cnki.cn

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

Data sharing time: August 2026, data sharing duration: 2 years, data sharing content: main indicators and related data. Use network platforms for sharing: CNKI, www.cnki.cn

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：

数据采集及录入：数据通过病例记录表进行记录，研究者将数据及时、完整、正确、清晰地录入SPSS 22.0系统中，之后对数据库进行两遍比对，期间若发现问题及时通知监查员，要求研究者做出回答。他们之间的各种疑问及解答的交换应当采用疑问表形式，疑问表应保存备查。 数据管理：当SPSS 22.0系统中数据核对无误后，由数据管理员写出数据库检查报告，其内容包括研究完成情况（含脱落受试者清单）、入选/排除标准检查、完整性检查、逻辑一致性检查、离群数据检查、时间窗检查、不良事件检查。在审核会议上，由主要研究者、申办单位代表、监查员、数据管理员和统计人员对受试者签署知情同意书、数据库检查报告中提出的问题做出决议，写出审核报告，数据库同时将被锁定。

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

Data collection and entry: The data were recorded through the case record table, and the researcher recorded the data into the SPSS 22.0 system in a timely, complete, correct and clear manner, and then compared the database twice. During the period, if any problem was found, the researcher was promptly notified and asked to answer. The exchange of questions and answers between them shall be in the form of a question table, which shall be kept for future reference. Data management: When the data in SPSS 22.0 system is verified correctly, the data manager will write out the database inspection report, which includes the study completion status (including the list of dropped subjects), inclusion/exclusion criteria, integrity check, logical consistency check, outlier data check, time window check, and adverse event check. At the audit meeting, the main researcher, the representative of the bidding unit, the supervisor, the data administrator and the statistician will make a decision on the informed consent signed by the subjects and the problems raised in the database inspection report, write the audit report, and the database will be locked.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-02-24 15:41:52