今天是:2022-05-24 星期二

在物理治疗师视频连线指导与家人支持下对社区老年膝骨关节炎进行运动训练与教育:基于随机对照试验的VFEE-KOA方案
下载XML文档

注册号:

Registration number:

ChiCTR2100041978 

最近更新日期:

Date of Last Refreshed on:

2021-03-29 

注册时间:

Date of Registration:

2021-01-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

在物理治疗师视频连线指导与家人支持下对社区老年膝骨关节炎进行运动训练与教育:基于随机对照试验的VFEE-KOA方案  

Public title:

Video-linked by physiotherapists and supported by family, exercise and education for community-dwelling older patients with knee osteoarthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

在物理治疗师视频连线指导与家人支持下对社区老年膝骨关节炎进行运动训练与教育:基于随机对照试验的VFEE-KOA方案  

Scientific title:

Video-linked by physiotherapists and supported by family, exercise and education for community-dwelling older patients with knee osteoarthritis: a protocol of VFEE-KOA program based on a randomized controlled trial  

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:

王琳 

研究负责人:

何成奇 

Applicant:

Wang Lin 

Study leader:

Chengqi He 

申请注册联系人电话:

Applicant telephone:

+86 15982258637 

研究负责人电话:

Study leader's telephone:

+86 18980601618 

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:

wanglin1996@stu.scu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

hxkfhcq2015@126.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:

中国四川成都国学巷37号 

研究负责人通讯地址:

中国四川成都国学巷37号 

Applicant address:

Department of Rehabilitation Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, China 

Study leader's address:

Department of Rehabilitation Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 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:

四川大学华西医院康复医学科 

Applicant's institution:

Department of Rehabilitation Medicine, West China Hospital, Sichuan 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:

2020年审(945)号 

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:

四川大学华西医院伦理委员会 

Name of the ethic committee:

Ethics Committee of West China Hospital, Sichuan University  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-11-26 

伦理委员会联系人:

邓绍林 

Contact Name of the ethic committee:

Shaolin Deng 

伦理委员会联系地址:

中国四川省成都市国学巷37号 

Contact Address of the ethic committee:

37 Guoxue Lane, Wuhou District, Chengdu, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川大学华西医院康复医学科,中国四川省成都市国学巷37号 

Primary sponsor's address:

Department of Rehabilitation Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District

经费或物资来源:

本研究由国家自然科学基金(81972146)、四川省科学技术厅(20YYJC3320)、四川省卫生厅(20PJ034)、四川大学华西医院(ZYGD18018)资助。 

Source(s) of funding:

National Natural Science Foundation (81972146), Sichuan Province Department of Science and Technology (20YYJC3320), Sichuan Province Health Commission(20PJ034), West China hospital (ZYGD18018) 

研究疾病:

骨关节炎 

Target disease:

Osteoarthritis 

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:

比较两种运动项目对社区膝关节骨性关节炎患者疼痛、功能、心理健康的影响,并探讨产生影响的生理、心理机制。 

Objectives of Study:

To compare the effects on pain, function, psychosocial well-being of two types of exercise programs for patients with knee osteoarthritis in the community, and to explore the physiological, psychosocial mechanisms that produce the effects. 

药物成份或治疗方案详述:

每月提供关于KOA的教育信息,每周指导进阶运动,每周指导特定运动2次。干预组和对照组的运动方案分别为神经肌肉运动和股四头肌运动。所有在家庭或社区进行的活动都将得到受试者家庭的支持。运动指导和教育将通过在线视频链接进行。 

Description for medicine or protocol of treatment in detail:

Education delivering information about KOA monthly, instructed progressive exercise weekly, and specific exercise twice weekly. The exercise programs of the intervention and controlled group are neuromuscular exercise and quadriceps exercise, respectively. All the exercise in home or communities will be supported by the family of the participant. And the instruction and education will be delivered by online video-link. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

对于在社区居住的老年人,纳入标准包括: (1)入组时至少50岁; (2)符合美国风湿病学会的症状性KOA标准; (3)K-L分级显示0~III级; (4)国际骨关节炎研究学会JSN分级0-2级; (5)每次锻炼都有家人的支持,确保基本安全,确保使用视频连线和观看视频。 

Inclusion criteria

The community-dwelling elders are potentially eligible, if they: (1) are at least 50 years old at the time of enrolment; (2) meet the criteria for symptomatic KOA according to the American College of Rheumatology; (3) have an X-ray image showing grades 0-III using the Kellgren & Lawrence; (4) have an X-ray image showing grades 0-2 in joint space narrowing based on the Osteoarthritis Research Society International classification; (5) have the support of family members every exercise session to ensure the basic safety, the use of video connection and video viewing. 

排除标准:

(1) 在过去12个月内接受过关节成形术、关节镜检查或膝关节开放手术,或计划在未来6个月内接受选择性膝关节置换手术; (2) 有其他关节问题(例如风湿性关节炎、严重骨质疏松症或骨折); (3) 有可能限制运动的确诊或疑似疾病(如脑血管瘤、劳力性心绞痛、严重贫血、固定频率起搏器、完全性房室传导阻滞等) (4) 有可能在未经监督的情况下参与运动而使用体力活动准备问卷30; (5) 有高血压和糖尿病未经监测和治疗; (6) 有认知功能损害的,用Mini-Cog31筛查;或 (7) 已确认有严重的精神障碍(如精神分裂症、抑郁症、偏执性精神病、躁狂症、智力低下引起的精神障碍)。 

Exclusion criteria:

(1) Have undergone arthroplasty, arthroscopy, or open surgery on the knee in the past 12 months, or plan to undergo an elective knee joint replacement surgery in the next 6 months; (2) have other joint problems (rheumatoid arthritis, severe osteoporosis, or fracture for example; (3) have confirmed or suspected diseases that may restrict exercise (cerebral hemangioma, exertional angina pectoris, severe anemia, fixed-rate pacemaker, complete atrioventricular block for example); (4) are at risk of participating in the exercise without supervision on screening using the physical activity readiness questionnaire; (5) are with hypertension and diabetes without monitoring and treatment; (6) have cognitive impairment on screened with Mini-Cog; or (7) have confirmed serious mental disorders (schizophrenia, major depression, paranoid psychosis, mania, mental disorders caused by mental retardation for example).  

研究实施时间:

Study execute time:

From2020-12-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2021-01-11To 2021-04-30 

干预措施:

Interventions:

组别:

神经肌肉训练

样本量:

55

Group:

neuromuscular exercise

Sample size:

干预措施:

患者教育和神经肌肉运动

干预措施代码:

01

Intervention:

education and neuromuscular exercise

Intervention code:

组别:

股四头肌训练

样本量:

55

Group:

quadriceps exercise

Sample size:

干预措施:

患者教育和股四头肌训练

干预措施代码:

02

Intervention:

education and quadriceps exercise

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

自我报告疼痛评分

指标类型:

主要指标 

Outcome:

self-reported pain

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自我报告功能评分

指标类型:

主要指标 

Outcome:

self-reported function

Type:

Primary 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 50 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):

符合条件的参与者将按1:1的比例随机分为神经肌肉组和股四头肌组。符合条件的参与者将根据性别和K-L分级进行分层,并使用R软件中的统计软件包,根据入组顺序顺序,每周用计算机方式生的可变区组(成至少四名参与者)的分配序列。随机分组将由临床医学院的独立分析员(Y.K.)进行,该分析员不参与研究或干预。受试者和物理治疗师将通过在线信息得到通知。

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

Eligible participants will be randomly assigned to the neuromuscular group and quadriceps group at the ratio of 1:1. Eligible participants will be stratified on sex and Kellgren & Lawrence atlas, and the allocation will be computer-generated in varied blocks of a minimum of four participants.

盲法:

评估人员、数据管理人员和统计分析人员将处于盲态。

Blinding:

Evaluators, data managers, and statistical analysts will be blinded.

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):

学术期刊发表 请阅读网页注册指南中关于 原始数据共享 的内容。

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

Publication on the journal.

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:

所有结果数据将由特定的评估人员在参与者的家中或社区收集,并以电子方式存储。为管理我科临床资料,开发了电子数据库。

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

All outcomes data will be collected by specific evaluators at the homes or communities of the participants and will be stored electronically. The electronic database has been developed for managing clinical data in our department.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2021-01-10
返回列表