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马王堆导引术对早中期膝骨关节炎患者功能康复的疗效观察

注册号：

Registration number：

ITMCTR2025000719

最近更新日期：

Date of Last Refreshed on：

2025-04-13

注册时间：

Date of Registration：

2025-04-13

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

马王堆导引术对早中期膝骨关节炎患者功能康复的疗效观察

Public title：

Observation on the Therapeutic Effect of Mawangdui Daoyin Technique on the Functional Rehabilitation of Patients with Early and Middle-stage Knee Osteoarthritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

马王堆导引术对早中期膝骨关节炎患者功能康复的疗效观察

Scientific title：

Observation on the Therapeutic Effect of Mawangdui Daoyin Technique on the Functional Rehabilitation of Patients with Early and Middle-stage Knee Osteoarthritis

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：

韦臻韬

研究负责人：

欧梁

Applicant：

wei zhentao

Study leader：

ou liang

申请注册联系人电话：

Applicant telephone：

+86 17608967176

研究负责人电话：

Study leader's telephone：

+86 15675824165

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：

1399470868@qq.com

研究负责人电子邮件：

Study leader's E-mail：

ouliang2020@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：

湖南省长沙市岳麓区麓山路58号

研究负责人通讯地址：

湖南省长沙市岳麓区麓山路58号

Applicant address：

No. 58 Lushan Road Yuelu District Changsha City Hunan Province

Study leader's address：

No. 58 Lushan Road Yuelu District Changsha City Hunan Province

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：

湖南省中医药研究院

Applicant's institution：

Hunan Academy of Traditional 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：

伦审【2024】230号

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：

湖南省中医药研究院附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/10/22 0:00:00

伦理委员会联系人：

戎宽

Contact Name of the ethic committee：

rong kuan

伦理委员会联系地址：

湖南省长沙市岳麓区麓山路 58 号

Contact Address of the ethic committee：

No. 58 Lushan Road Yuelu District Changsha City Hunan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 88883760

伦理委员会联系人邮箱：

Contact email of the ethic committee：

87048174@qq.com

研究实施负责（组长）单位：

湖南省中医药研究院

Primary sponsor：

Hunan Academy of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区岳华路 142 号

Primary sponsor's address：

No. 142 Yuehua Road Yuelu District Changsha City Hunan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

湖南省中医药研究院附属医院

具体地址：

湖南省长沙市岳麓区麓山路 58 号

Institution
hospital：

Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine

Address：

No. 58 Lushan Road Yuelu District Changsha City Hunan Province

经费或物资来源：

湖南省中医药管理局

Source(s) of funding：

Hunan Administration of Traditional Chinese Medicine

研究疾病：

膝骨关节炎

研究疾病代码：

Target disease：

Knee Osteoarthritis

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：

其它

Others

研究目的：

明确健身气功马王堆导引术居家锻炼对早中期KOA患者的治疗与康复效果，旨在继承与发展中国传统养生功法，充分发挥中医药独特优势，形成适合中国KOA患者的特色运动处方，为进一步运用传统运动功法防治慢性筋骨疾病的推广应用提供依据。

Objectives of Study：

Clarify the therapeutic and rehabilitative effects of the home-based exercise of Mawangdui Daoyin Technique a fitness qigong on patients with knee osteoarthritis in the early and middle stages. The aim is to inherit and develop traditional Chinese health cultivation techniques give full play to the unique advantages of traditional Chinese medicine formulate characteristic exercise prescriptions suitable for Chinese patients with KOA and provide a basis for the further promotion and application of traditional exercise techniques in the prevention and treatment of chronic musculoskeletal diseases.

药物成份或治疗方案详述：

本研究分为两组，具体的干预方法如下：(一)观察组：进行国家体育总局推广的健身气功-马王堆导引术训练，每周训练5天，每天1次，每次约10分钟,强度以Borg评分11-13分为宜（Borg评分详见附录5），训练前进行5分钟的放松运动，练习时应心静体松、呼吸白然。由熟练掌握马王堆导引术的医师指导功法训练、监督1周，患者需熟练完成马王堆导引术单套动作，并掌握方法和注意事项，完成后各自发放马王堆导引术教学视频，以便居家查阅学习。马王堆导引术组运动过程中需佩戴运动手环，患者或家属监测患者的心率，使心率变化不超过最大心率的50%～60%,确保安全性。在研究者指导下远程监督患者的居家锻炼，共干预3个月。（二）对照组：进行股四头肌训练，每周训练5天，每天1次，每次约10分钟，训练前进行5分钟的放松运动，由医师指导股四头肌训练、监督1周，患者需熟练完成股四头肌训练动作流程，完成后各自发放股四头肌训练动作教学视频，以便居家查阅学习。对照组运动过程中需佩戴运动手环，患者或家属监测患者的心率，使心率变化不超过最大心率的50%～60%,确保安全性。共干预3个月。（股四头肌训练：患者取仰卧位，将膝关节尽量伸直，在10°、30°、60°分别用力把大腿前方的股四头肌绷紧，踝关节尽量背伸持续20s,感到肌肉酸胀再放松，3个角度为1次。2次为1组，组间休息1分钟，每天练4组，约10分钟。）

Description for medicine or protocol of treatment in detail：

This study was divided into two groups and the specific intervention methods are as follows: (I) Observation Group Patients in this group underwent training in the Mawangdui Daoyinshu a health - qigong promoted by the General Administration of Sport of China. The training was carried out 5 days a week once a day approximately 10 minutes each time. The intensity was preferably rated 11 - 13 on the Borg Scale (for details of the Borg Scale refer to Appendix 5). A 5 - minute relaxation exercise was conducted before each training session. During the practice patients were required to keep a calm mind relaxed body and natural breathing. A physician proficient in Mawangdui Daoyinshu provided guidance and supervision for the qigong training for one week. Patients were required to master the single - set movements of Mawangdui Daoyinshu as well as the methods and precautions. After that each patient was provided with a teaching video of Mawangdui Daoyinshu for home study. Patients in the Mawangdui Daoyinshu group were required to wear a sports bracelet during the exercise. The patient or their family members monitored the patient's heart rate to ensure that the heart rate change did not exceed 50% - 60% of the maximum heart rate thus guaranteeing safety. Under the guidance of the researchers the patients' home - based exercises were remotely supervised for a total of 3 months. (II) Control Group Patients in this group underwent quadriceps femoris muscle training. The training was also carried out 5 days a week once a day approximately 10 minutes each time. A 5 - minute relaxation exercise was conducted before each training session. A physician provided guidance and supervision for the quadriceps femoris muscle training for one week. Patients were required to master the movement process of the quadriceps femoris muscle training. After that each patient was provided with a teaching video of the quadriceps femoris muscle training for home study. Patients in the control group were required to wear a sports bracelet during the exercise. The patient or their family members monitored the patient's heart rate to ensure that the heart rate change did not exceed 50% - 60% of the maximum heart rate thus guaranteeing safety. The intervention lasted for 3 months in total. Quadriceps femoris muscle training: The patient lies in a supine position straightens the knee joint as much as possible and tenses the quadriceps femoris muscle in front of the thigh at 10° 30° and 60° respectively. At the same time the ankle joint is dorsiflexed as much as possible and held for 20 seconds. The patient relaxes after feeling muscle soreness. One cycle consists of these three angles. Two cycles make up one set with a 1 - minute rest between sets. Patients are required to practice 4 sets a day which takes about 10 minutes.

纳入标准：

1.符合中华中医药学会发布的《膝骨关节炎中西医结合诊疗指南（2023年版）》KOA诊断标准及早中期分期标准的患者 2.原发性KOA，年龄50～75岁 3.自愿参与本试验研究，并签署知情同意书。

Inclusion criteria

1.Patients who meet the diagnostic criteria for KOA and the staging criteria for the early and middle stages as stipulated in the "Guidelines for the Diagnosis and Treatment of Knee Osteoarthritis by Integrating Traditional Chinese and Western Medicine (2023 Edition)" issued by the Chinese Association of Traditional Chinese Medicine. 2.Patients with primary KOA whose age ranges from 50 to 75 years old. 3.Those who voluntarily participate in this experimental study and sign the informed consent form.

排除标准：

1.有马王堆导引术、太极拳、五禽戏、易筋经等传统保健功法锻炼习惯者 2.因肢体功能或其他身体功能而不能进行功法锻炼者 3.非原发性KOA，或其它膝关节疾病，如类风湿性关节炎、创伤性关节炎、痛风性关节炎、血友病性关节炎等 4.近3个月内接受过KOA的相关治疗，包括药物治疗（如口服药物、外用药等）、非药物治疗（如针灸、物理治疗等）、关节腔内药物注射、关节镜手术等 5.合并有严重的心脑血管、肝、肾、血液等系统疾病，或严重消化道疾病，如溃疡、出血等 6.精神类疾病无法配合研究者。

Exclusion criteria：

1.Those who have the exercise habit of traditional health care qigong techniques such as Mawangdui Daoyin Technique Taijiquan Five-Animal Exercises Yijinjing etc. 2.Those who are unable to perform qigong exercises due to limb function or other physical functions. 3.Patients with non-primary KOA or other knee joint diseases such as rheumatoid arthritis traumatic arthritis gouty arthritis hemophilic arthritis etc. 4.Those who have received relevant treatments for KOA within the past 3 months including drug treatments (such as oral medications external medications etc.) non-drug treatments (such as acupuncture physical therapy etc.) intra-articular drug injection arthroscopic surgery etc. 5.Those with concurrent severe cardiovascular and cerebrovascular liver kidney blood and other systemic diseases or severe digestive tract diseases such as ulcers bleeding etc. 6.Patients with mental diseases who are unable to cooperate with the researchers.

研究实施时间：

Study execute time：

从From 2025-03-27

至To      2026-03-25

征募观察对象时间：

Recruiting time：

从From 2025-05-20

至To      2026-03-20

干预措施：

Interventions：

组别：

观察组

样本量：

31

Group：

Observation group

Sample size：

干预措施：

马王堆导引术训练

干预措施代码：

Intervention：

Mawangdui Daoyin Technique training

Intervention code：

组别：

对照组

样本量：

31

Group：

Control group

Sample size：

干预措施：

股四头肌训练

干预措施代码：

Intervention：

Quadriceps femoris training

Intervention code：

样本总量 Total sample size ： 62

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

湖南省中医药研究院附属医院

单位级别：

三甲

Institution/hospital：

The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

生活质量评分

指标类型：

次要指标

Outcome：

Quality of Life Score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

下肢肌力测试

指标类型：

次要指标

Outcome：

Lower Extremity Muscle Strength 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：

疼痛视觉模拟评分

指标类型：

主要指标

Outcome：

Visual Analog 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：

西安大略和麦马斯特大学骨关节炎指数可视化量表 （WOMAC）评分

指标类型：

次要指标

Outcome：

Western Ontario and McMaster Universities Osteoarthritis Index Visualization Scale (WOMAC) Score

Type：

Secondary 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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 50 岁
Min age years
最大 75 岁
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）：

采用随机数字表法按1:1比例将62患者分为观察组和对照组，每组各31人，本方法由研究者彭娜姿进行操作

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

Sixty-two patients were divided into an observation group and a control group in a 1:1 ratio using the random number table method with 31 patients in each group. This method was operated by the researcher Peng Nazhi

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

否

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）：

通过学术论文发表数据

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

Publish the data through academic papers.

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：

病例记录表，电子采集和管理系统

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

(Case Record Form CRF);(Electronic Data Capture EDC)

数据管理委员会：

Data Managemen Committee：

有

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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