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阶梯式站桩功法治疗女性膝骨性关节炎下肢骨骼肌肉特征及脑网络小世界变化的影响研究

注册号：

Registration number：

ITMCTR2025000696

最近更新日期：

Date of Last Refreshed on：

2025-04-10

注册时间：

Date of Registration：

2025-04-10

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

阶梯式站桩功法治疗女性膝骨性关节炎下肢骨骼肌肉特征及脑网络小世界变化的影响研究

Public title：

Exploring the Effects of a Stepwise Zhanzhuang Training Approach on Lower Limb Skeletal Muscle Characteristics and Brains Small-World Network Changes in Women with Knee Osteoarthritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

阶梯式站桩功法治疗女性膝骨性关节炎下肢骨骼肌肉特征及脑网络小世界变化的影响研究

Scientific title：

Exploring the Effects of a Stepwise Zhanzhuang Training Approach on Lower Limb Skeletal Muscle Characteristics and Brains Small-World Network Changes in Women with 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：

白璧辉

研究负责人：

白璧辉

Applicant：

Bihui Bai

Study leader：

Bihui Bai

申请注册联系人电话：

Applicant telephone：

13919263260

研究负责人电话：

Study leader's telephone：

13919263260

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：

1010768605@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1010768605@qq.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：

上海市静安区芷江中路274号

研究负责人通讯地址：

上海市静安区芷江中路274号

Applicant address：

Translation: No. 274 Zhijiang Middle Road Jingan District Shanghai.

Study leader's address：

Translation: No. 274 Zhijiang Middle Road Jingan District Shanghai.

申请注册联系人邮政编码：

Applicant postcode：

200241

研究负责人邮政编码：

Study leader's postcode：

200241

申请人所在单位：

上海市中医医院（上海中医药大学附属市中医医院）

Applicant's institution：

Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University 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：

2025SHL-KY-51-02

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：

上海市中医医院伦理委员会

Name of the ethic committee：

Shanghai Hospital of Traditional Chinese Medicine Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/10 0:00:00

伦理委员会联系人：

凌丽

Contact Name of the ethic committee：

Li Ling

伦理委员会联系地址：

上海市静安区芷江中路274号

Contact Address of the ethic committee：

Translation: No. 274 Zhijiang Middle Road Jingan District Shanghai.

伦理委员会联系人电话：

Contact phone of the ethic committee：

021-56628310

伦理委员会联系人邮箱：

Contact email of the ethic committee：

shszyyyec@126.com

研究实施负责（组长）单位：

上海市中医医院（上海中医药大学附属市中医医院）

Primary sponsor：

Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市静安区芷江中路274号

Primary sponsor's address：

Translation: No. 274 Zhijiang Middle Road Jingan District Shanghai.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市中医医院（上海中医药大学附属市中医医院）

具体地址：

上海市静安区芷江中路274号

Institution
hospital：

Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine

Address：

Translation: No. 274 Zhijiang Middle Road Jingan District Shanghai.

经费或物资来源：

自筹经费

Source(s) of funding：

Funds raised independently

研究疾病：

膝骨性关节炎

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

通过对阶梯式站桩功法干预女性膝骨关节炎（knee osteoarthritis, KOA）患者的随机对照试验（randomized controlled trial, RCT）研究，分析下肢骨骼肌肉生物力学特征分析，从多维度验证其在缓解关节疼痛、增强关节稳定性及提升生活质量等方面的临床价值，为中医功法治疗女性KOA患者提供有效依据，基于功能磁共振成像（functional Magnetic Resonance Imaging , fMRI）研究阶梯式站桩功法调控KOA患者关节疼痛的神经机制，明确阶梯式站桩功法干预对神经调节的作用，为科学设计多维度治疗方案提供理论支持。

Objectives of Study：

In a randomized controlled trial (RCT) the Stepped Zhanzhuang Exercise was investigated as an intervention for female patients suffering from knee osteoarthritis (KOA). The study analyzed the biomechanical properties of the lower limb musculoskeletal system substantiating the clinical benefits of the exercise in reducing joint pain enhancing joint stability and improving overall quality of life. These findings offer robust evidence supporting the use of traditional Chinese medicine exercises in the treatment of female KOA patients. Furthermore utilizing functional Magnetic Resonance Imaging (fMRI) the research delved into the neural mechanisms through which the Stepped Zhanzhuang Exercise mitigates joint pain in KOA patients. By elucidating the exercises impact on neural regulation the study provides a theoretical foundation for the development of scientifically-informed multidimensional treatment approaches.

药物成份或治疗方案详述：

第一部分：阶梯式站桩功法和下肢拉伸训练同时进行，每次至少招募10人，分批进行，随机分配给两组。下肢拉伸训练组患者进行下肢训练主要包括三个动作：楼梯训练、靠墙静蹲和扶墙提踵训练；阶梯式站桩功法组，练习功法动作4周后对所有患者进行评估检测患者的VAS、WOMAC评分得分好于或等于之前的得分时，患者转强度更大的下一阶梯锻炼水平，其他患者继续维持现有阶梯治疗，两组都将接受KOA相关的宣教内容，具体宣讲内容如下：① 日常注意事项例如：减重、饮食、日常活动；② 医学认识及患者疑问解答；③参与者在研究期间保持其正常的饮食摄入、生活方式和身体活动。试验结束后（12周后），对照组患者将被安排进行与治疗组相同的站桩训练作为补偿。 第二部分：根据受试者意愿，从阶梯式站桩功法和下肢拉伸训练每组抽取有意愿的受试者15人，在干预前和干预12周后采集组数据，进行2次磁共振检查。

Description for medicine or protocol of treatment in detail：

First Part In this study the Stepped Zhanzhuang Exercise Group and lower limb stretching training were conducted simultaneously. At least 10 participants were recruited for each batch and they were randomly assigned to two groups. The lower limb stretching training group performed exercises that primarily consisted of three movements: stair training wall squatting and wall-supported heel raise training. For the Stepped Zhanzhuang Exercise Group after four weeks of practice all patients were evaluated. Those whose VAS and WOMAC scores were equal to or better than their previous scores were transitioned to a higher intensity level of the next exercise stage while other patients continued with their current level of treatment. Both groups received education on KOA including: ① Daily precautions such as weight loss diet and daily activities; ② Medical understanding and answers to patient inquiries; ③ Participants maintained their normal dietary intake lifestyle and physical activity throughout the study period. After the trial ended (12 weeks later) the control group patients were scheduled to receive the same Stepped Zhanzhuang training as the treatment group as compensation. Second Part: Voluntarily 15 participants from each group (Stepped Zhanzhuang Exercise and lower limb stretching) underwent two magnetic resonance imaging sessions one before and one after the 12-week intervention.

纳入标准：

①年龄≥50岁以上，＜70岁以下，女性； ②符合KOA诊断标准，受试者过去一个月内，疼痛存在以下任一情况如： 步行、上下楼梯、站立、平躺； ③至少一个膝盖轻度至中度胫骨或髌骨关节炎（单侧或双侧膝关节X线k-L分级1-3级）； ④骨科医生体格检查确有存在膝部疼痛功能障碍，但能够参加锻炼； ⑤视觉模拟量表（VAS）≥2分（0～10分); ⑥同意参加研究并签署书面知情同意书。

Inclusion criteria

① Females aged between 50 and 70 years; ② Meet the diagnostic criteria for Knee Osteoarthritis (KOA) with pain experienced in at least one of the following situations within the past month: walking climbing stairs standing or lying down; ③ Have at least one knee with mild to moderate tibial or patellar arthritis graded 1-3 on unilateral or bilateral knee X-rays (K-L grading system); ④ An orthopedic doctors physical examination confirms knee pain and dysfunction yet the subject is capable of participating in exercise; ⑤ Score of 2 or higher on the Visual Analogue Scale (VAS) which ranges from 0 to 10; ⑥ Willing to participate in the study and sign a written informed consent form.

排除标准：

①过去有相关传统功法锻炼及物理治疗经历者； ②经医生评估诊断，患者的身体条件及精神状况无法进行安全锻炼，或存在心、肝、肾、脑血管和造血系统的严重急慢性器质性疾病、精神疾病、活动性癌症等； ③过去1个月内有关节腔注射及外科手术史者； ④入组评测时不借辅助设备无法行走者； ⑤既往存在药物过敏史。

Exclusion criteria：

① Individuals with prior experience in traditional exercise practices and physical therapy; ② Patients determined by a physician to be physically or mentally unfit for safe exercise due to severe acute or chronic conditions affecting the heart liver kidneys cerebrovascular system hematopoietic system mental health or active cancer; ③ Those who have undergone joint cavity injections or surgical procedures within the last month; ④ Individuals unable to walk independently at the time of enrollment assessment; ⑤ Those with a history of drug allergies.

研究实施时间：

Study execute time：

从From 2025-03-10

至To      2027-03-09

征募观察对象时间：

Recruiting time：

从From 2025-04-20

至To      2026-03-09

干预措施：

Interventions：

组别：

阶梯式站桩功法组

样本量：

57

Group：

Stepped Zhanzhuang Exercise Group

Sample size：

干预措施：

阶梯式站桩功法

干预措施代码：

Intervention：

Stepped Zhanzhuang Exercise Method

Intervention code：

组别：

下肢拉伸训练组

样本量：

57

Group：

Lower Limb Stretching Training Group

Sample size：

干预措施：

下肢拉伸训练法

干预措施代码：

Intervention：

Lower Limb Stretching Training Method

Intervention code：

样本总量 Total sample size ： 114

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市中医医院（上海中医药大学附属市中医医院）

单位级别：

三甲公立中医医院

Institution/hospital：

Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine

Level of the institution：

Three-Level A Public Traditional Chinese Medicine Hospital

测量指标：

Outcomes：

指标中文名：

脑功能磁共振成像

指标类型：

次要指标

Outcome：

functional Magnetic Resonance Imaging , fMRI

Type：

Secondary indicator

测量时间点：

干预前、干预12周后

测量方法：

磁共振机器检测

Measure time point of outcome：

Pre-intervention and Post-12-Week Intervention

Measure method：

Magnetic Resonance Imaging (MRI) Scan

指标中文名：

生活质量简表

指标类型：

次要指标

Outcome：

Short Form 36 Health Survey

Type：

Secondary indicator

测量时间点：

干预前、干预12周后

测量方法：

量表评分

Measure time point of outcome：

Pre-intervention and Post-12-Week Intervention

Measure method：

Rating Scale Evaluation

指标中文名：

骨性关节炎指数评分表

指标类型：

次要指标

Outcome：

Western Ontario and McMaster Universities Osteoarthritis Index 西安大略大学和麦克马斯特大学骨关节炎指数

Type：

Secondary indicator

测量时间点：

干预前、干预12周后

测量方法：

量表评分

Measure time point of outcome：

Pre-intervention and Post-12-Week Intervention

Measure method：

Rating Scale Evaluation

指标中文名：

下肢肌肉粘弹性测量

指标类型：

次要指标

Outcome：

Assessment of Lower Limb Muscle Stiffness

Type：

Secondary indicator

测量时间点：

干预前、干预12周后

测量方法：

用MyotonPro设备测量

Measure time point of outcome：

Pre-intervention and Post-12-Week Intervention

Measure method：

Measured with MyotonPro Device

指标中文名：

视觉模拟评分量表

指标类型：

主要指标

Outcome：

visual analog scales VAS

Type：

Primary indicator

测量时间点：

干预前、干预12周后

测量方法：

量表分数评分

Measure time point of outcome：

Pre-intervention and Post-12-Week Intervention

Measure method：

Rating Scale Evaluation

采集人体标本：

Collecting sample(s)
from participants：

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 70 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

研究采取随机、平行对照的方法，指标评价及统计人员对分组不知情，治疗师对于结局评价不知情。由统计人员采用统计软件完成随机数字表，然后将随机数字表发放给第三方研究人员进行分配隐藏。第三方人员将数字表装入不透明的信封，每个信封都标记有时间和签名，然后统一交给研究协调人员。研究协调人员对于潜在的 KOA患者电话联系咨询是否愿意参加临床试验，并按照随机号码将患者分配到随机号码将受试者按照1:1分配入阶梯式站桩功法试验组和拉伸训练对照组。

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

The study adopted a randomized parallel-control method with the index evaluators and statisticians blinded to the grouping and the therapists blinded to the outcome evaluation. The random number table was generated by the statisticians using statistical software and then the random number table was handed over to a third-party researcher for allocation concealment. The third-party individual placed the number table in opaque envelopes each marked with the time and signature and then uniformly handed them over to the study coordinator. The study coordinator contacted potential KOA patients by phone to inquire about their willingness to participate in the clinical trial and assigned patients to the stepped Zhanzhuang exercise test group and the stretching training control group according to the random numbers in a 1:1 ratio.

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）：

无

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

No

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：

第一部分采用纸质CRF病历记录表采集数据，第二部分采用Excel进行记录与管理。

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

The first part uses a paper-based CRF medical record form to collect data and the second part uses Excel for recording and management.

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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