基于“元觉知”的正念训练联合太极拳对2型糖尿病周围神经病变的效果研究

注册号:

Registration number:

ITMCTR2200005649

最近更新日期:

Date of Last Refreshed on:

2021-06-20

注册时间:

Date of Registration:

2021-06-20

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于“元觉知”的正念训练联合太极拳对2型糖尿病周围神经病变的效果研究

Public title:

Research on the effect of mindfulness training combined with Tai Chi based on ''meta-awareness'' on type 2 diabetic peripheral neuropathy

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于“元觉知”的正念训练联合太极拳对2型糖尿病周围神经病变的效果研究

Scientific title:

Research on the effect of mindfulness training combined with Tai Chi based on ''meta-awareness'' on type 2 diabetic peripheral neuropathy

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2100047595 ; ChiMCTR2200005649

申请注册联系人:

廖顺琪

研究负责人:

王芳

Applicant:

Liao Shunqi

Study leader:

Wang Fang

申请注册联系人电话:

Applicant telephone:

+86 15102808850

研究负责人电话:

Study leader's telephone:

+86 18980880156

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:

liaoshunqi1225@163.com

研究负责人电子邮件:

Study leader's E-mail:

wangf7640@163.com

申请单位网址(自愿提供):

Study leader's 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:

四川省成都市锦江区岷江路1668号

研究负责人通讯地址:

四川省成都市金牛区十二桥路39号

Applicant address:

1688 Minjiang Road, Jinjiang District, Chengdu, Sichuan

Study leader's address:

39 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan

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:

成都中医药大学

Applicant's institution:

Chengdu University of TCM

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2021KL-040

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

成都中医药大学附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of Hospital of Chengdu University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2021/5/29 0:00:00

伦理委员会联系人:

马喜桃

Contact Name of the ethic committee:

Ma Xitao

伦理委员会联系地址:

四川省成都市金牛区十二桥路39号

Contact Address of the ethic committee:

39 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan

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:

成都中医药大学附属医院

Primary sponsor:

Hospital of Chengdu University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

四川省成都市金牛区十二桥路39号

Primary sponsor's address:

39 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan

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):

成都中医药大学附属医院

具体地址:

金牛区十二桥路39号

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Address:

39 Shi'erqiao Road, Jinniu District

经费或物资来源:

成都中医药大学附属医院科技发展基金

Source(s) of funding:

Science and technology development fund of Hospital of Chengdu University of Traditional Chinese Medicine

研究疾病:

糖尿病周围神经病变

研究疾病代码:

Target disease:

Diabetic Peripheral Neuropathy

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

本课题旨在探讨基于“元觉知”的正念训练联合太极拳对2型糖尿病周围神经病变患者神经功能及生活质量的影响效果。

Objectives of Study:

The purpose of this study is to explore the effect of mindfulness training based on ''meta-awareness''combined with Taijiquan on neurologic function and quality of life in patients with type 2 diabetic peripheral neuropathy.

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.年龄为40-75岁; 2.符合2017版中国2型糖尿病防治指南中对糖尿病周围神经病变的诊断标准; 3.肌力为Ⅳ级以上,可以完成中等强度负荷运动的人群; 4.入组前未参与过系统太极拳练习及正念训练; 5.在研究期间没有使用任何其他辅助或综合治疗方法干预糖尿病周围神经病变; 6.意识清楚,听力正常,能够与人正常交流,能够理解并跟做示范动作; 7.签署知情同意书。

Inclusion criteria

1. Aged 40-75 years; 2. Meet the diagnostic criteria for diabetic peripheral neuropathy in the 2017 Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes; 3. Patients with muscle strength above grade IV who can complete moderate-intensity load exercise; 4. Have not participated in systematic Taijiquan practice and mindfulness training before joining the group; 5. No other adjuvant or comprehensive treatment methods were used to intervene in diabetic peripheral neuropathy during the study period; 6. Clear consciousness, normal hearing, able to communicate with people normally, able to understand and follow demonstration actions; 7. Sign the informed consent.

排除标准:

1.伴重度感染,重度心、肾等脏器的功能损伤,自身免疫疾病,其他神经内分泌疾病患者; 2.有出血倾向的血液病患者; 3.伴有严重骨质疏松或其他运动禁忌证者; 4.有糖尿病足部溃疡或截肢; 5.妊娠或哺乳期妇女; 6.拒绝配合。

Exclusion criteria:

1. Patients with severe infection, severe heart, kidney and other organ dysfunction, autoimmune diseases, and other neuroendocrine diseases; 2. Hematological patients with bleeding tendency; 3. Those with severe osteoporosis or other exercise contraindications; 4. Diabetic foot ulcer or amputation; 5. Pregnant or lactating women; 6. Refuse to cooperate.

研究实施时间:

Study execute time:

From 2021-07-16

To      2022-07-16

征募观察对象时间:

Recruiting time:

From 2021-07-16

To      2022-07-16

干预措施:

Interventions:

组别:

太极拳组

样本量:

32

Group:

Tai Chi group

Sample size:

干预措施:

太极拳

干预措施代码:

Intervention:

Tai Chi

Intervention code:

组别:

联合治疗组

样本量:

32

Group:

Combination therapy group

Sample size:

干预措施:

正念训练联合太极拳

干预措施代码:

Intervention:

Mindfulness training combined with Tai Chi

Intervention code:

组别:

对照组

样本量:

32

Group:

Control group

Sample size:

干预措施:

常规健康教育

干预措施代码:

Intervention:

Routine health education

Intervention code:

样本总量 Total sample size : 96

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):

成都中医药大学附属医院

单位级别:

三级甲等

Institution/hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

密歇根评分

指标类型:

次要指标

Outcome:

Michigan neuropathy screening instrument

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

正念注意觉知量表

指标类型:

次要指标

Outcome:

Mindful attention awareness scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多伦多临床评分

指标类型:

次要指标

Outcome:

Toronto clinical scoring

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经传导速度测试

指标类型:

主要指标

Outcome:

Nerve conduction velocity

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

震动感觉阈值

指标类型:

主要指标

Outcome:

Vibration sensory thresholds

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量量表

指标类型:

主要指标

Outcome:

Quality of life scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

区段电流感觉阈值

指标类型:

主要指标

Outcome:

Segmental current sensing threshold

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:

标本中文名:

血液

组织:

Sample Name:

Blood

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:

正在进行

Recruiting

年龄范围:

最小 40
Min age years
最大 75
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

根据社区年度健康体检,社区义诊和居民健康档案来选取研究对象。采用整群抽样方法抽取成都市的3个社区。为了避免研究对象沾染,采用居住地分组,通过抽签法将3个社区分别划入对照组,太极拳组,正念训练联合太极拳组。

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

The study subjects were selected based on the annual health examination in the community, the community visiting clinic, and the resident health files. A cluster sampling method was used to sample the 3 communities in Chengdu City.

盲法:

由于本干预研究实施的特性,本研究对研究对象、研究者(同为干预方案主要实施者、结局分析者)未采用盲法。

Blinding:

Open-label

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):

研究完成后6个月内于www.chictr.org.cn公布原始数据,作为论文附件在投稿时和论文一起上传

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

PD would be shared through www.chictr.org.cn, and it would be disclosed within six months after finishing the research,and it would also be uploaded with the theis as attachments

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:

1、采用纸质版病历记录表采集相关信息; 2、数据由两名研究人员独立放入Epidata 3.1数据库中。

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

1. The paper medical records were used to collect relevant information; 2. The data were independently put into EpiData 3.1 database by two researchers.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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