Daoyin Exercises in the Treatment of Parkinson's Disease --Study Protocol for a Leading Randomized Controlled Clinical Study

注册号:

Registration number:

ITMCTR2024000438

最近更新日期:

Date of Last Refreshed on:

2024-09-14

注册时间:

Date of Registration:

2024-09-14

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

导引功法治疗帕金森病的疗效—先导性随机对照临床研究方案

Public title:

Daoyin Exercises in the Treatment of Parkinson's Disease --Study Protocol for a Leading Randomized Controlled Clinical Study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

导引功法治疗帕金森病的疗效先导性随机对照临床研究

Scientific title:

Daoyin Exercises in the Treatment of Parkinson's Disease --A Leading Randomized Controlled Clinical Study

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:

申请注册联系人:

王南卜

研究负责人:

王南卜

Applicant:

Nanbu Wang

Study leader:

Nanbu Wang

申请注册联系人电话:

Applicant telephone:

+86 139 0306 3126

研究负责人电话:

Study leader's telephone:

+86 139 0306 3126

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:

nanbuwang@gzucm.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

nanbuwang@gzucm.edu.cn

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:

广州市白云区机场路12号

研究负责人通讯地址:

广州市白云区机场路12号

Applicant address:

No.12 Airport Rd.Baiyun District Guangzhou Guangdong China

Study leader's address:

No.12 Airport Rd.Baiyun District Guangzhou Guangdong 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:

中医证候全国重点实验室,广州中医药大学第一附属医院

Applicant's institution:

State Key Laboratory of Traditional Chinese Medicine Syndrome ;The First Affiliated Hospital of Guangzhou University of Chinese Medicine

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:

K-2024-107

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

广州中医药大学第一附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the first Affiliated Hospital of Guangzhou University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/8/14 0:00:00

伦理委员会联系人:

黎欣盈,唐云

Contact Name of the ethic committee:

Xinying Li ;Yun Tang

伦理委员会联系地址:

广州市白云区机场路12号

Contact Address of the ethic committee:

No.12 Airport Rd.Baiyun District Guangzhou Guangdong China

伦理委员会联系人电话:

Contact phone of the ethic committee:

020-36588667

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gztcmlunli@163.com

研究实施负责(组长)单位:

广州中医药大学第一附属医院

Primary sponsor:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

研究实施负责(组长)单位地址:

广州市白云区机场路12号

Primary sponsor's address:

No.12 Airport Rd.Baiyun District Guangzhou Guangdong 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第一附属医院

具体地址:

广州市白云区机场路12号

Institution
hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Address:

No.12 Airport Rd.Baiyun District Guangzhou Guangdong Chinah

经费或物资来源:

国家重点研发计划

Source(s) of funding:

National Key R&D Program of China

研究疾病:

帕金森病

研究疾病代码:

Target disease:

Parkinson's disease

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:

探索导引功法治疗帕金森病的有效性,评估进行大规模随机临床试验的可行性

Objectives of Study:

To investigate the efficacy of Daoyin exercises in the treatment of Parkinson's disease and to evaluate the feasibility of conducting large-scale randomized clinical trials.

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)符合西医帕金森病诊断标准,“左旋多巴”等基础药物用量稳定者;(2)年龄25~80岁;(3)Hoehn-Yahr分级在1-3级以内者;(4)意识清楚,生命体征平稳;(5)无明显智力和听力障碍,能正常沟通交流者;(6)签署知情同意书者

Inclusion criteria

(1)Meet the diagnostic criteria for Parkinson's disease and have a stable dosage of basic drugs such as "levodopa";(2)Age 25~80 years;(3)Hoehn-Yahr stage 1-3;(4)Clear consciousness and stable vital signs;(5)No significant intellectual or hearing impairment and able to communicate normally;(6)Willing to sign an informed consent form.

排除标准:

(1)脑血管病、中毒等各种病因所致的帕金森综合征,进行性核上性麻痹、多系统萎缩、路易体痴呆及皮质基底节变性等帕金森叠加综合征; (2)有较重大疾病者,如严重的肝肾、肿瘤、内分泌疾病等; (3)存在骨折、创伤术后等原因不能自行站立、行走者; (4)有严重认知障碍、精神疾病或耳聋等交流沟通存在障碍者; (5)近三个月练习太极拳、易筋经、五禽戏等中国传统运动及瑜伽等其他身心运动者; (6)近三个月参与其他治疗方案的临床试验者;

Exclusion criteria:

(1) Parkinson's syndrome and Parkinson plus syndrome caused by cerebrovascular disease poisoning and other causes; (2)Presence of serious diseases such as severe liver and kidney disease or tumors or endocrine diseases etc.; (3) Those who are unable to stand or walk on their own due to fractures trauma and other reasons; (4) Those with severe cognitive impairment mental illness or deafness and other communication difficulties; (5) Those who have practiced traditional Chinese sports such as Tai Chi Yi Jin Jing and Wufowl Opera in the past three months as well as other physical and mental exercises such as yoga; (6) Those who have participated in clinical trials of other treatment regimens in the past three months;

研究实施时间:

Study execute time:

From 2024-06-01

To      2025-06-30

征募观察对象时间:

Recruiting time:

From 2024-10-01

To      2025-01-31

干预措施:

Interventions:

组别:

实验组

样本量:

15

Group:

experimental group

Sample size:

干预措施:

基础药物治疗+导引功法练习

干预措施代码:

Intervention:

Daoyin exercises practice

Intervention code:

组别:

对照组

样本量:

15

Group:

control group

Sample size:

干预措施:

基础药物治疗

干预措施代码:

Intervention:

none

Intervention code:

样本总量 Total sample size : 30

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广州中医药大学第一附属医院

单位级别:

三甲

Institution/hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

PDQ-39量表

指标类型:

次要指标

Outcome:

the 39-item Parkinson's Disease Questionnaire

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

医院焦虑抑郁量表

指标类型:

次要指标

Outcome:

Hospital Anxiety and Depression 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:

起立-行走计时测试

指标类型:

次要指标

Outcome:

Timed Up and Go 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:

统一帕金森病评定量表第三部分

指标类型:

主要指标

Outcome:

Unified Parkinson's Disease Rating Scale-III

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Berg 平衡量表

指标类型:

次要指标

Outcome:

Berg Balance 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:

蒙特利尔认知评估量表

指标类型:

次要指标

Outcome:

Montreal Cognitive Assessment

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

帕金森病睡眠量表

指标类型:

次要指标

Outcome:

Parkinson's Disease Sleep 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:

非运动症状评价量表

指标类型:

主要指标

Outcome:

Non-Motor Symptoms Scale

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:

血清

组织:

Sample Name:

Serum

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:

尚未开始

Not yet recruiting

年龄范围:

最小 25
Min age years
最大 80
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):

采用随机分配的方法分组,将符合纳排标准的30名受试者按1:1随机分为实验组及对照组各15例。随机分配由中央随机系统区组随机的随机数字法产生,中央随机系统会将纳入患者随机分组。随机分配系统的研发及执行由广州中医药大学临床研究与数据中心人员完成。

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

A total of 30 subjects were randomly assigned and randomly divided into experimental group and control group with 15 case in each group according to 1:1. The random assignment is generated by the random number method of block randomization in the central random system which randomized patients.The random distribution system was developed and implemented by the Clinical Research and Data Center of Guangzhou University of Chinese Medicine.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

不共享

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

Don't share

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:

包括CRF表的填写,监察员核查,根据CRF建立录入程序,DQF表的产生及复核,数据库修改检查,不良事件及合并用药编码,盲态下的数据审核,数据锁定及审核传递等。

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

It included filling in CRF form inspection by inspector establishment of entry procedures according to CRF generation and review of DQF form ;verification of database modification adverse event and combined drug coding; blinded data review ;data lock and audit transmission etc.

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above