ChiCTR2500099424 版本V1.0 版本创建时间2025/03/24 11:48:54 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500099424 

最近更新日期：

Date of Last Refreshed on：

 2025-03-24 11:48:47 

注册时间：

Date of Registration：

 2025-03-24 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

五禽戏干预对老年冠心病临界病变患者心脏储备功能的影响

Public title：

The effect of Wuqinxi intervention on cardiac reserve function in elderly patients with intermediate coronary artery disease

注册题目简写：

English Acronym：

研究课题的正式科学名称：

五禽戏干预对老年冠心病临界病变患者心脏储备功能的影响

Scientific title：

The effect of Wuqinxi intervention on cardiac reserve function in elderly patients with intermediate coronary artery disease

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：

孙卫婧 

研究负责人：

杨欢  

Applicant：

Sun Weijing 

Study leader：

Yang Huan  

申请注册联系人电话：

Applicant telephone：

 +86 136 3558 6127

研究负责人电话：

Study leader's
telephone：

+86 139 5668 2418

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：

 657461720@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 94612332@qq.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：

亳州市谯城区药都路1625号

研究负责人通讯地址：

安徽省亳州市谯城区魏武大道与北一环交叉口西北角

Applicant address：

No. 1625 Yaodu Road, Qiaocheng District, BoZhou of Anhui

Study leader's address：

Weiwu Avenue and the north of the intersection northwest cornerQiaocheng District Bozhou City Anhui Province

申请注册联系人邮政编码：

Applicant postcode：

 286000

研究负责人邮政编码：

Study leader's postcode：

 286000

申请人所在单位：

亳州职业技术学院

Applicant's institution：

Bozhou Vocational and Technical College

研究负责人所在单位：

亳州市中医院

Affiliation of the Leader：

Bozhou Hospital of Traditional Chinese Medicine

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：

 2023KY-65

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：

亳州市中医院伦理委员会

Name of the ethic committee：

Ethics Committee of Bozhou Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-10-21 00:00:00

伦理委员会联系人：

刘帅帅

Contact Name of the ethic committee：

Liu Shuaishuai

伦理委员会联系地址：

亳州市魏武大道与北一环交叉口西北角

Contact Address of the ethic committee：

Weiwu Avenue and North one ring intersection northwest corner,Bozhou ,Anhui

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 558 551 9540

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：

亳州市中医院

Primary sponsor：

Bozhou Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

安徽省亳州市谯城区魏武大道与北一环交叉口西北角

Primary sponsor's address：

Weiwu Avenue and the north of the intersection northwest cornerQiaocheng District Bozhou City Anhui 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)：

安徽

市(区县)：

亳州

Country：

China

Province：

Anhui

City：

Bozhou

单位(医院)：

亳州市中医院

具体地址：

亳州市魏武大道与北一环交叉口西北角

Institution
hospital：

Bozhou Traditional Chinese Medicine Hospital

Address：

Weiwu Avenue and North one ring intersection northwest corner,Bozhou ,Anhui

经费或物资来源：

亳州职业技术学院

Source(s) of funding：

Bozhou Vocational and Technical College

研究疾病：

冠心病  

Target disease：

Coronary heart disease

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探讨增强型体外反搏（EECP）联合五禽戏对不符合介入治疗指征的冠心病临界病变患者心脏储备功能的影响。  

Objectives of Study：

To investigate the effect of enhanced external counterpulsation (EECP) combined with Wuqinxi exercises on the cardiac reserve function of patients with intermediate stenosis of coronary artery disease who do not meet the indications for interventional therapy.

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. 患者符合冠心病临界病变诊断标准年龄≥60岁； 2. IVUS检查结果不符合介入治疗指征； 3. 患者临床资料完整，CAG及IVUS影像清晰。

Inclusion criteria

1. The patients who met the diagnostic criteria of coronary artery disease were >= 60 years old. 2. IVUS results must not meet the indications for interventional treatment ; 3. The clinical data of the patients must be complete, and the CAG and IVUS images must be clear.

排除标准：

1. 患有严重的心、肺、肝、肾功能不全及其他严重急、慢性病的患者； 2. 患有严重的感染性疾病、自身免疫病、恶性肿瘤（含恶性血液系统疾病）及精神疾病者； 3. 患有持续性心房颤动、高度房室传导阻滞及既往植入起搏器或埋藏式心脏复律除颤器的患者； 4. 患有重度主动脉狭窄或关闭不全或肥厚性心肌病伴流出道梗阻的患者； 5. 合并下肢静脉血栓形成的患者； 6. 无法配合完成CPET测试、EECP治疗和（或）五禽戏练习的患者。

Exclusion criteria：

1. Patients with severe heart, lung, liver, or kidney dysfunction, or other serious acute or chronic diseases; 2. Patients with severe infectious diseases, autoimmune diseases, malignant tumours (including malignant haematological diseases), or mental illnesses; 3. Patients with persistent atrial fibrillation, high-grade atrioventricular block, or those who have previously had a pacemaker or implantable cardioverter-defibrillator implanted; 4. Patients with severe aortic stenosis or regurgitation, or hypertrophic cardiomyopathy with outflow obstruction; 5. Patients with concomitant lower extremity venous thrombosis; 6. Patients unable to cooperate in completing CPET testing, EECP treatment, and/or Wuqinxi exercises.

研究实施时间：

Study execute time：

从 From 2023-10-21 00:00:00至 To 2025-05-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-02-21 00:00:00 至 To 2025-04-30 00:00:00

干预措施：

Interventions：

组别：

增强型体外反搏组

样本量：

 30

Group：

Enhanced external counterpulsation Treatment Group

Sample size：

干预措施：

标准化EECP设备，确保压力参数和治疗时间统一。治疗频次与时间：每周5次，每次60分钟，总疗程为7周（共35次）。 操作流程：（1）患者取仰卧位，双下肢穿戴反搏气囊。（2）根据心电图同步记录，气囊在心脏舒张期充气，收缩期快速放气。（3）治疗期间监测血压、心率和患者的耐受情况，确保安全。

干预措施代码：

 EECP

Intervention：

Standardized EECP Equipment Ensure uniformity in pressure parameters and treatment duration. Treatment Frequency and Duration: 5 sessions per week, 60 minutes per session, for a total of 7 weeks (35 sessions in total). Operational Procedure: The patient is placed in a supine position with pneumatic cuffs applied to both lower limbs. The cuffs are synchronised with the electrocardiogram (ECG) to inflate during diastole and deflate rapidly during systole. Blood pressure, heart rate, and patient tolerance are monitored throughout the treatment to ensure safety.

Intervention code：

组别：

五禽戏联合体外反搏组

样本量：

 30

Group：

EECP Combined with Wuqinxi Treatment group

Sample size：

干预措施：

EECP联合五禽戏组在EECP组治疗基础上进行五禽戏练习。依据中国国家体育总局提供的的五禽戏口令版动作，为患者提供五禽戏练习指南与教学视频，由科室心脏康复团队指导并带领患者练习五禽戏，总共包括虎举、虎扑、鹿抵、鹿奔、熊运、熊晃、猿提、猿摘、鸟伸及鸟飞十式。练习过程中密切关注患者情况，如有不适立即停止练习并给予相应处置。每次练习时间为45分钟（包括5分钟准备活动、35分钟五禽戏练习和5分钟放松活动），每周3次，总疗程7周。

干预措施代码：

 EECP+WQX

Intervention：

The EECP + Wuqinxi Group performs Wuqinxi exercises in addition to the EECP treatment provided to the EECP Group. Based on the Wuqinxi instructional movements issued by the General Administration of Sport of China, patients are provided with a detailed practice guide and instructional videos for Wuqinxi. The cardiac rehabilitation team supervises and leads patients in practicing Wuqinxi, which includes ten movements: Tiger Raising, Tiger Leaping, Deer Resistance, Deer Running, Bear Moving, Bear Shaking, Monkey Lifting, Monkey Picking, Bird Stretching, and Bird Flying. During the practice, patients' conditions are closely monitored, and the exercise is immediately stopped if any discomfort occurs, followed by appropriate medical intervention. Each practice session lasts 45 minutes, including 5 minutes of warm-up, 35 minutes of Wuqinxi practice, and 5 minutes of relaxation. Patients practice three times per week for a total of 7 weeks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

 亳州 

Country：

China

Province：

Anhui

City：

Bozhou

单位(医院)：

 亳州市中医院 

单位级别：

 三甲 

Institution
hospital：

Bozhou Traditional Chinese Medicine Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

冠脉造影检查

指标类型：

主要指标

Outcome：

Coronary angiography was performed, GAG

Type：

Primary indicator

测量时间点：

基线（第0周）、中期（第4周）和终点（第7周）

测量方法：

通过冠脉造影观察冠状动脉狭窄程度和侧支循环情况。记录冠脉血流储备比（FFR）及其他相关指标。

Measure time point of outcome：

Baseline (Week 0), Midpoint (Week 4), and Endpoint (Week 7)

Measure method：

Coronary angiography is used to observe the degree of coronary artery stenosis and collateral circulation. The fractional flow reserve (FFR) and other relevant indicators are recorded. You said:

指标中文名：

心肺运动试验

指标类型：

主要指标

Outcome：

Cardiopulmonary exercise testing(CPET)

Type：

Primary indicator

测量时间点：

基线（第0周）、中期（第4周）和终点（第7周）

测量方法：

患者在呼吸面罩监测下进行递增负荷运动测试。记录最大摄氧量（VO2 max）、无氧阈（AT）和心输出量变化。

Measure time point of outcome：

Baseline (Week 0), Midpoint (Week 4), and Endpoint (Week 7)

Measure method：

Patients perform an incremental load exercise test under monitoring with a respiratory mask. Maximum oxygen uptake (VO2 max), anaerobic threshold (AT), and cardiac output changes are recorded.

指标中文名：

6分钟步行试验

指标类型：

次要指标

Outcome：

A 6-minute walk test was performed

Type：

Secondary indicator

测量时间点：

基线（第0周）、中期（第4周）和终点（第7周）

测量方法：

在30米走廊内，记录患者在6分钟内步行的总距离（6-MWD）。测试前后监测心率、血压和氧饱和度，记录主观疲劳感评分（Borg量表）。

Measure time point of outcome：

Baseline (Week 0), Midpoint (Week 4), and Endpoint (Week 7)

Measure method：

In a 30-meter corridor, the total walking distance covered by the patient within 6 minutes (6-MWD) is recorded. Heart rate, blood pressure, and oxygen saturation are monitored before and after the test, and subjective fatigue is assessed using the Borg Scale.

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：

0thers  

Note：

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 60 岁 years
最大 Max age 岁 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）：

随机数字序列采用计算机生成，由研究团队中独立成员使用统计软件（如SPSS或Excel）的随机数生成功能生成一组唯一的随机数字。根据患者编号范围（如1至90），按随机数表的顺序将患者分配至EECP组或EECP+五禽戏组，分组比例为1:1。随机分组结果由研究人员密封保存，基线评估完成后揭盲以避免偏倚。分组过程中严格进行质量控制，确保随机化过程的准确性和公平性，从而为研究组间的均衡性和研究结果的可靠性提供保障。

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

The random number sequence is generated using a computer by an independent statistician from the research team, utilising random number generation functions in statistical software such as SPSS or Excel. Based on the patient number range (e.g., 1 to 90), patients are assigned to either the EECP group or the EECP + Wuqinxi group in a 1:1 ratio following the order of the random number table. The randomisation results are securely sealed and unblinded only after baseline assessments to avoid bias. Quality control is strictly enforced during the randomisation process to ensure accuracy and fairness, providing a reliable foundation for balanced group allocation and robust research outcomes.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本研究采用单盲法设计。患者及负责评估的研究人员在基线评估及干预期间均对分组情况不知情，随机分组结果密封于不可透视的信封中，由专门负责干预的人员在基线评估完成后揭盲并执行干预。由于干预形式（EECP与五禽戏）的可见性，干预执行人员知晓分组情况以确保干预的准确性和个体化调整，但通过对患者和评估人员的盲化，最大限度减少了主观偏倚和信息泄露，从而提高了研究结果的科学性和可信度。

Blinding：

This study adopts a single-blind design. Both the patients and the assessment staff are blinded to the group allocation during the baseline assessment and intervention period. The randomization results are sealed in opaque, non-transparent envelopes and unblinded only by the personnel responsible for the intervention after the completion of baseline assessments. Due to the visible nature of the interventions (EECP and Wuqinxi), the intervention staff are aware of the group assignments to ensure the accuracy and individualized adjustments of the interventions. However, by blinding the patients and assessment staff, subjective bias and information leakage are minimized, thereby enhancing the scientific rigor and credibility of the study results.

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）：

共享原始数据的方式与时间： 原始数据将在研究完成后6个月内对外共享，获取方式为联系研究负责人。申请者需发送电子邮件至 657461720@qq.com 提出申请。数据共享将仅限于学术研究目的，需经批准后提供。

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

Raw data will be shared within 6 months of study completion by contacting the study leader. Applicants should email 657461720@qq.com to apply. Data sharing will be limited to academic research purposes and is subject to approval.

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：

数据采集和管理： 数据采集通过设计规范化的病例记录表（Case Record Form, CRF），纸质版填写后转录为Excel电子表格进行数据录入和管理。数据将定期由研究团队进行审核和校验，以确保准确性和完整性。所有数据均存储在加密的电子设备中，严格限制访问权限，确保数据安全。

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

Data acquisition and management: Data collection A standardized Case Record Form (CRF) was designed and the paper version was filled in and transcribed into Excel spreadsheet for data entry and management. The data will be regularly reviewed and verified by the research team to ensure accuracy and completeness. All data is stored in encrypted electronic devices with strictly restricted access to ensure data security.

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：

  2025-03-24 11:48:47