ChiCTR2600121080 版本V1.0 版本创建时间2026/03/25 10:40:42 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：

 ChiCTR2600121080 

最近更新日期：

Date of Last Refreshed on：

 2026-03-25 10:40:35 

注册时间：

Date of Registration：

 2026-03-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

增强型体外反搏联合运动训练对PCI术后患者的疗效观察

Public title：

To observe the effect of enhanced external counterpulsation combined with exercise training on patients after percutaneous coronary intervention (PCI)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

增强型体外反搏联合运动训练对PCI术后患者的疗效观察

Scientific title：

To observe the effect of enhanced external counterpulsation combined with exercise training on patients after percutaneous coronary intervention (PCI)

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：

蔡雨璐 

研究负责人：

周谊霞 

Applicant：

Cai Yulu 

Study leader：

Zhouyi Xia 

申请注册联系人电话：

Applicant telephone：

 +86 151 2534 9611

研究负责人电话：

Study leader's
telephone：

+86 159 0851 5850

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：

 1904622502@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 zhouyixia2014@126.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：

中国贵州省贵阳市花溪区栋青路4号

研究负责人通讯地址：

中国贵州省贵阳市云岩区飞山街83号

Applicant address：

No.4, Dongqing Road, Huaxi District, Guiyang, Guizhou, China

Study leader's address：

No. 83, Feishan Street, Yunyan District, Guiyang, Guizhou, 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：

贵州中医药大学

Applicant's institution：

Guizhou University of Traditional Chinese Medicine

研究负责人所在单位：

贵州中医药大学第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Guizhou University of 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：

 LW20250210

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：

贵州中医药大学第二附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-02-10 00:00:00

伦理委员会联系人：

吴增光

Contact Name of the ethic committee：

Wu Zengguang

伦理委员会联系地址：

中国贵州省贵阳市云岩区飞山街83号

Contact Address of the ethic committee：

No. 83, Feishan Street, Yunyan District, Guiyang, Guizhou, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 85258506

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：

贵州中医药大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Guizhou University of Chinese Medicine

研究实施负责（组长）单位地址：

中国贵州省贵阳市云岩区飞山街83号

Primary sponsor's address：

No. 83, Feishan Street, Yunyan District, Guiyang, Guizhou, 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)：

贵州

市(区县)：

贵阳

Country：

China

Province：

Guizhou

City：

Guiyang

单位(医院)：

贵州中医药大学第二附属医院

具体地址：

中国贵州省贵阳市云岩区飞山街83号

Institution
hospital：

The Second Affiliated Hospital of Guizhou University of Chinese Medicine

Address：

No. 83, Feishan Street, Yunyan District, Guiyang, Guizhou, China

经费或物资来源：

来源于本研究负责人的贵州省科技厅课题

Source(s) of funding：

Derived from the topic of Guizhou Provincial Science and Technology Department of the person in charge of this study

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：

1.有氧-抗阻运动联合增强型体外反搏有望明确该联合疗法对冠心病支架术后患者血管内皮功能及生活质量的改善作用，进而可能为将其整合进常规康复护理方案提供依据，并以此为核心探索个性化、多维度康复护理计划的制定、实施及管理模式，期望能优化护理效果，提升患者康复结局，降低并发症风险。 2.鼓励患者积极参与有氧-抗阻运动，并配合EECP治疗，进而有望改善血管内皮功能，提升生活质量，增强康复信心，提高治疗主动性，为全方位促进患者术后身心康复提供助力。  

Objectives of Study：

1. Aerobic-resistance exercise combined with enhanced external counterpulsation is expected to clarify the improvement effect of this combined therapy on vascular endothelial function and quality of life in patients with coronary heart disease after stent implantation, which may provide a basis for integrating it into the routine rehabilitation nursing plan, and explore the formulation, implementation and management mode of personalized and multi-dimensional rehabilitation nursing plan as the core, so as to optimize the nursing effect. To improve the rehabilitation outcome of patients and reduce the risk of complications. 2.Encourage patients to actively participate in aerobic-resistance exercise and EECP treatment, which is expected to improve vascular endothelial function, improve quality of life, enhance rehabilitation confidence, improve treatment initiative, and provide help for promoting postoperative physical and mental rehabilitation of patients in an all-round way.

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）性别不限，年龄在60－79[79]岁之间； （2）有良好的沟通能力，没有精神疾病病史； （3）得到知情同意后，主动选择加入这个研究项目； （4）能接受并承诺完成每周≥3次的运动训练； （5）既往行冠状动脉旁路移植术或经皮冠脉介入治疗时间＞3个月；

Inclusion criteria

(1) Both sexes, aged between 60-79[79] years old; (2) good communication skills and no history of mental illness; (3) actively choose to participate in the study after obtaining informed consent; (4) able to accept and commit to exercise training >=3 times per week; (5) previous coronary artery bypass grafting or percutaneous coronary intervention time > 3 months;

排除标准：

（1）高危患者（如大面积心肌梗死、恶性心律失常、心源性休克）； （2）既往脑血管疾病史； （3）静息性胸痛频繁发作者； （4）近4周内患有急性感染性疾病； （5）合并严重肾衰竭、恶性肿瘤、重度贫血（Hb<80g/L）或严重肺部疾病）； （6）存在显著阻碍运动的骨关节疾病； （7）罹患严重精神疾病； （8）冠心病病情严重，预计研究期间需再次行PCI干预者。

Exclusion criteria：

(1) high-risk patients (such as massive myocardial infarction, malignant arrhythmia, cardiogenic shock); (2) previous history of cerebrovascular disease; (3) patients with frequent resting chest pain; (4) acute infectious diseases within the past 4 weeks; (5) complicated with severe renal failure, malignant tumor, severe anemia (Hb<80g/L) or severe lung disease; (6) bone and joint diseases that significantly hinder exercise; (7) suffering from severe mental illness; (8) patients with severe coronary heart disease who were expected to undergo PCI intervention again during the study period.

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2026-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-01 00:00:00 至 To 2026-12-01 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 20

Group：

Control Group

Sample size：

干预措施：

（1）实施地点： 贵州中医药大学第二附属医院心内科 （2）实施内容： 实施常规心脏康复，参考《冠心病心脏康复基层指南（2020年）》[81]中指出“心脏康复是指应用药物、运动、营养、精神心理及行为干预、戒烟限酒五大处方及综合性医疗措施。予以适当生活指导，提醒患者保持低盐、低脂饮食，尽早戒烟，控制高血压、糖尿病、高血脂等基础疾病，保持情绪稳定，规律作息，每日进行适量运动；根据患者症状，予以硝酸酯类、β受体阻滞剂、钙离子阻滞剂等药物治疗，告知用药注意事项，提醒患者定期复诊。 （3）实施方法： 1）药物治疗：优化药物治疗(ODT)侧重于药物调节,包括使用抗血小板药物、降脂药物以及β受体阻滞剂等药物来减轻心脏负荷，调节血脂水平，预防不良心血管事件的发生。参考2018年国家卫生计生委合理用药专家委员会、中国药师协会颁布《冠心病合理用药指南》第2版，患者遵医嘱剂量用药：A、阿司匹林肠溶片（石药集团欧意药业，国药准字H20153035，100mg）口服B、单硝酸异山梨酯片（丽珠集团丽珠制药厂，国药准字H10930189，10mg）口服C、硫酸氢氯吡格雷片（乐普药业股份有限公司，国药准字H20123116，75mg）D、阿托伐他汀钙片（立普妥，辉瑞制药有限公司，国药准字H20051408），口服。 2）生活方式干预：A、合理饮食：针对冠心病PCI术后接受有氧-抗阻运动联合EECP治疗的患者，嘱其坚持低盐低脂饮食，多食用富含膳食纤维和维生素的新鲜蔬菜、水果、谷物，同时补充优质蛋白。这样的饮食方案有助于维持血管内皮细胞的正常代谢，为运动及EECP治疗提供良好的营养支持，从而更好地配合联合干预措施改善血管内皮功能与生活质量。B、戒烟限酒：对于接受有氧-抗阻运动联合EECP治疗的冠心病PCI术后患者，医护人员需强化对其吸烟及饮酒危害的健康教育，着重说明烟酒会干扰血管内皮功能的恢复，影响联合治疗的效果。同时嘱家属做好日常监督工作，协助患者严格戒烟限酒。C、休息：接受有氧-抗阻运动联合EECP治疗的冠心病PCI术后患者，需保持健康睡眠，保证充足的休息时间。良好的休息有助于促进机体恢复，保障运动及EECP治疗期间的体力储备。对于存在睡眠障碍的患者，应及时给予综合护理干预，如心理疏导、睡眠环境调整等，避免睡眠问题影响血管内皮功能修复及生活质量提升，确保联合干预措施的顺利实施。 3）心理疏导：在有氧-抗阻运动联合EECP对冠心病PCI术后患者的干预过程中，心理疏导至关重要。需鼓励患者保持积极乐观的心态，因为积极心态能增强患者对有氧-抗阻运动和EECP治疗的依从性，而良好的依从性是保证联合治疗有效改善血管内皮功能的前提。医护人员要针对性地指导患者自我调节，如通过听音乐、与他人交流等方式释放压力，并提供专业的心理咨询服务。及时帮助患者缓解焦虑、抑郁等负面情绪，可避免负面情绪引发的神经内分泌紊乱对血管内皮功能造成不良影响，进而确保联合治疗能更有效地发挥作用，提升患者的生活质量。

干预措施代码：

Intervention：

(1) Implementation Location Department of Cardiology, The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine (2) Implementation Content Routine cardiac rehabilitation was implemented, with reference to the "Primary Care Guidelines for Cardiac Rehabilitation of Coronary Heart Disease (2020)" [81]. The guidelines state that "cardiac rehabilitation involves the application of five core prescriptions—medication, exercise, nutrition, psychosocial and behavioral interventions, and smoking cessation/alcohol restriction—along with comprehensive medical measures." Patients were provided with appropriate lifestyle guidance, including advice to maintain a low-salt and low-fat diet, quit smoking as soon as possible, control underlying conditions such as hypertension, diabetes, and hyperlipidemia, maintain emotional stability, adhere to a regular sleep schedule, and engage in appropriate daily physical activity. Based on patient symptoms, medications such as nitrates, beta-blockers, and calcium channel blockers were prescribed, accompanied by education on medication precautions and reminders for regular follow-up visits. (3) Implementation Methods 1) Pharmacotherapy: Optimal Drug Therapy (ODT) focused on pharmaceutical management, including the use of antiplatelet agents, lipid-lowering drugs, and beta-blockers to reduce cardiac workload, regulate blood lipid levels, and prevent adverse cardiovascular events. With reference to the "Guideline for Rational Medication in Coronary Heart Disease (2nd Edition)" issued in 2018 by the National Health Commission Expert Committee on Rational Drug Use and the China Pharmacist Association, patients took medications at physician-prescribed doses: A. Aspirin Enteric-coated Tablets (Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical, NMPA Approval No. H20153035, 100mg), orally. B. Isosorbide Mononitrate Tablets (Livzon Group Livzon Pharmaceutical Factory, NMPA Approval No. H10930189, 10mg), orally. C. Clopidogrel Bisulfate Tablets (Lepu Pharmaceutical Co., Ltd., NMPA Approval No. H20123116, 75mg), orally. D. Atorvastatin Calcium Tablets (Lipitor, Pfizer Pharmaceuticals Ltd., NMPA Approval No. H20051408), orally. 2) Lifestyle Intervention: A. Rational Diet: For post-PCI CHD patients undergoing combined aerobic-resistance exercise and EECP therapy, they were instructed to adhere to a low-salt, low-fat diet, consuming plenty of fresh vegetables, fruits, grains rich in dietary fiber and vitamins, along with adequate high-quality protein. This dietary regimen helps maintain normal vascular endothelial cell metabolism and provides solid nutritional support for exercise and EECP therapy, thereby better facilitating the combined intervention to improve vascular endothelial function and quality of life. B. Smoking Cessation and Alcohol Restriction: For these patients, healthcare providers reinforced health education regarding the dangers of smoking and alcohol, emphasizing how they impede the recovery of vascular endothelial function and compromise the efficacy of the combined therapy. Family members were also instructed to provide daily supervision to assist patients in strictly quitting smoking and limiting alcohol. C. Rest: These patients were advised to maintain healthy sleep patterns and ensure adequate rest. Sufficient rest promotes physical recovery and preserves energy reserves for the demands of exercise and EECP therapy. For patients with sleep disturbances, comprehensive nursing interventions (e.g., psychological counseling, sleep environment adjustments) were provided promptly to prevent sleep issues from hindering the improvement of vascular endothelial function and quality of life, thus ensuring the smooth implementation of the combined intervention. 3) Psychological Counseling: Psychological counseling was considered crucial during the intervention of combined aerobic-resistance exercise and EECP for post-PCI CHD patients. Patients were encouraged to maintain a positive and optimistic mindset, as this enhances adherence to the exercise and EECP therapy. Good adherence is a prerequisite for the combined therapy to effectively improve vascular endothelial function. Healthcare staff provided targeted guidance on self-regulation techniques (e.g., listening to music, communicating with others to relieve stress) and offered professional psychological counseling services. Promptly addressing negative emotions like anxiety and depression helps prevent the associated neuroendocrine disturbances from adversely affecting vascular endothelial function. This ensures the combined therapy can work more effectively to enhance the patient's quality of life.

Intervention code：

组别：

运动组

样本量：

 20

Group：

Exercise Group

Sample size：

干预措施：

在对照组基础上予以有氧-抗阻运动训练，每次30min，于餐后1-3h进行，隔日一次，每周干预3次，共干预12周。 1.干预前准备：建立运动组微信群，发放太极拳、哑铃操、柔韧平衡操，两名专业人员示范并指导老年人操课动作。特殊原因未到达者需线上视频打卡完成。 2.运动过程：第二阶段，太极拳：以国家体育总局编创的太极拳动作为标准，配合《太极拳（国家体育总局标准版）》视频进行训练，10分钟1遍，每日1遍，共10分钟。 哑铃操（抗阻运动）：单个动作重复8-10次，分三组完成，10分钟。哑铃选用知名运动器材品牌所生产的可调节哑铃；阻力测定10RM，型号根据实际选购的产品确定。 柔韧平衡操：以促进身体放松、缓解肌肉紧张为目的，动作可参考专业的运动放松教程，配合舒缓的音乐进行练习，5分钟1遍，每日2遍，共10分钟。 （4）运动监护及注意事项： 1）患者每次进行太极拳、哑铃操、柔韧平衡操时，运动前、后，都要测量生命体征，合并高血压的患者，若出现血压过高（BP≥160/100mmHg）或过低（BP＜90/60mmHg），心动过速（HR＞100bpm）或节律不规整，皆不宜参与这四项运动； 2）运动过程中，患者在进行太极拳、哑铃操、柔韧平衡操时，若出现呼吸急促、心绞痛、头晕、心慌、胸闷、气短或大汗淋漓，或肢体活动不适，则应立即停止当前正在进行的运动； 3）完成太极拳、哑铃操、柔韧平衡操后，不宜立即进食，注意保暖，避免感冒发生。

干预措施代码：

Intervention：

On the basis of the intervention, the control group was given aerobic-resistance exercise training, 30min each time, 1-3h after meals, once every other day, 3 times a week for 12 weeks. 1. Preparation before intervention: an exercise group was established on wechat, and Tai chi, dumbbell exercises, and flexible balance exercises were distributed. Two professionals demonstrated and guided the exercises for the elderly. Those who do not arrive for special reasons need to complete the online video clocking. 2. Exercise process: The second stage, Taijiquan: The training was based on the Taijiquan movements created by the General Administration of Sports of China and combined with the video of Taijiquan (Standard version of the General Administration of Sports of China), once every 10 minutes, once a day, a total of 10 minutes. Dumbbell exercise (resistance exercise) : A single action repeat 8-10 times, divided into three groups to complete, 10 minutes. Dumbbells are adjustable dumbbells produced by famous sports equipment brands; The resistance was measured at 10RM, and the model was determined according to the actual product purchased. Flexibility balance exercise: to promote body relaxation, relieve muscle tension for the purpose of action can refer to professional sports relaxation tutorials, with soothing music to practice, 5 minutes 1 time, 2 times a day, a total of 10 minutes. (4) Exercise monitoring and precautions: 1) Vital signs should be measured before and after each Tai chi exercise, dumbbell exercise, and flexibility balance exercise. For patients with hypertension, if there is high blood pressure (BP>=160/100mmHg) or low blood pressure (BP < 90/60mmHg), tachycardia (HR > 100bpm) or irregular rhythm, Should not participate in any of the four sports; 2) During exercise, if the patient has shortness of breath, angina pectoris, dizziness, palpitation, chest tightness, shortness of breath or sweating, or physical activity discomfort during Tai Chi exercise, dumbbell exercise, and flexible balance exercise, the current exercise should be stopped immediately; 3) After completing Tai Chi, dumbbell exercises and flexibility balance exercises, it is not appropriate to eat immediately, pay attention to keep warm and avoid the occurrence of cold.

Intervention code：

组别：

EECP组

样本量：

 20

Group：

EECP group

Sample size：

干预措施：

实施方法：EECP疗法

干预措施代码：

Intervention：

Implementation Method: EECP Therapy The EECP therapy was administered using the pneumatic external counterpulsation device (Model: P-ECT/T1) manufactured by Chongqing Pushikang Technology Development Co., Ltd. Pre-Treatment Preparation: Device Inspection: The operator comprehensively inspected the counterpulsation device. This included verifying secure power cord connections, smooth operation of the air pump, normal display of all parameters on the screen, and testing the inflation/deflation functions to ensure no sticking or delays. This confirmed the overall good operational status of the machine, establishing a foundation for treatment safety. Patient Preparation: Patients were guided to arrive at the treatment room 15-20 minutes in advance and were seated in a quiet and comfortable waiting area to rest. This prevented emotional tension or vital sign fluctuations due to rushing. Patients were explicitly instructed to empty their bladders. Those experiencing difficulty urinating were provided appropriate assistance to prevent discomfort caused by a full bladder during the procedure. Patient Positioning and Cuff Application: The patient was assisted into a supine position on the counterpulsation bed. Appropriately sized cuffs were selected based on the patient's limb dimensions. The air was completely expelled from the cuffs, which were then inspected for surface damage and secure connections to ensure no air leaks. The cuffs were sequentially wrapped around the patient's thighs, calves, and buttocks, ensuring a snug but comfortable fit—tight enough for close contact without causing pressure. The ECG lead was then switched to the "ECG" position. Once a clear ECG waveform was displayed on the monitor, the inflation knob was slowly adjusted to precisely set the inflation signal at the peak of the T-wave and the deflation signal at or just before the peak of the P-wave. This positioning was repeatedly verified to ensure synchronization of the counterpulsation with the cardiac cycle. Treatment and Monitoring: The counterpulsation ratio was accurately set to 1:1, synchronizing the counterpulsation frequency with the patient's heart rate to ensure each heartbeat was assisted by a corresponding counterpulsation. The inflation/deflation switch was activated first, followed by the air pump switch. The initial inflation pressure was set at a low level and gradually adjusted according to the patient's tolerance, ultimately maintaining a stable pressure between 0.030 - 0.045 MPa. Throughout the treatment, the operator remained beside the patient, closely observing their facial expressions and limb movements, regularly inquiring about any discomfort (e.g., distension, numbness), and simultaneously monitoring real-time changes in the ECG waveform on the screen to ensure the procedure progressed as planned. Treatment Cessation Procedure: At the end of the treatment, the following sequence was strictly followed: first turning off the air pump, then pressing the stop button, and finally switching off the inflation button. This prevented potential device damage or patient discomfort due to incorrect operational sequence. The ECG electrodes were then carefully removed, using gentle action to avoid skin irritation. For patients with sensitive skin, the electrode sites were wiped with warm water beforehand. The cuffs were loosened in sequence from the buttocks to the thighs and then the calves. During removal, the limbs were closely examined for marks, redness, swelling, or other abnormalities, and the patient was monitored for adverse reactions such as dizziness, palpitations, or muscle soreness, with appropriate measures taken promptly if any issues were identified. Implementation Method: EECP Therapy The EECP therapy was administered using the pneumatic external counterpulsation device (Model: P-ECT/T1) manufactured by Chongqing Pushikang Technology Development Co., Ltd. Pre-Treatment Preparation: Device Inspection: The operator comprehensively inspected the counterpulsation device. This included verifying secure power cord connections, smooth operation of the air pump, normal display of all parameters on the screen, and testing the inflation/deflation functions to ensure no sticking or delays. This confirmed the overall good operational status of the machine, establishing a foundation for treatment safety. Patient Preparation: Patients were guided to arrive at the treatment room 15-20 minutes in advance and were seated in a quiet and comfortable waiting area to rest. This prevented emotional tension or vital sign fluctuations due to rushing. Patients were explicitly instructed to empty their bladders. Those experiencing difficulty urinating were provided appropriate assistance to prevent discomfort caused by a full bladder during the procedure. Patient Positioning and Cuff Application: The patient was assisted into a supine position on the counterpulsation bed. Appropriately sized cuffs were selected based on the patient's limb dimensions. The air was completely expelled from the cuffs, which were then inspected for surface damage and secure connections to ensure no air leaks. The cuffs were sequentially wrapped around the patient's thighs, calves, and buttocks, ensuring a snug but comfortable fit—tight enough for close contact without causing pressure. The ECG lead was then switched to the "ECG" position. Once a clear ECG waveform was displayed on the monitor, the inflation knob was slowly adjusted to precisely set the inflation signal at the peak of the T-wave and the deflation signal at or just before the peak of the P-wave. This positioning was repeatedly verified to ensure synchronization of the counterpulsation with the cardiac cycle. Treatment and Monitoring: The counterpulsation ratio was accurately set to 1:1, synchronizing the counterpulsation frequency with the patient's heart rate to ensure each heartbeat was assisted by a corresponding counterpulsation. The inflation/deflation switch was activated first, followed by the air pump switch. The initial inflation pressure was set at a low level and gradually adjusted according to the patient's tolerance, ultimately maintaining a stable pressure between 0.030 - 0.045 MPa. Throughout the treatment, the operator remained beside the patient, closely observing their facial expressions and limb movements, regularly inquiring about any discomfort (e.g., distension, numbness), and simultaneously monitoring real-time changes in the ECG waveform on the screen to ensure the procedure progressed as planned. Treatment Cessation Procedure: At the end of the treatment, the following sequence was strictly followed: first turning off the air pump, then pressing the stop button, and finally switching off the inflation button. This prevented potential device damage or patient discomfort due to incorrect operational sequence. The ECG electrodes were then carefully removed, using gentle action to avoid skin irritation. For patients with sensitive skin, the electrode sites were wiped with warm water beforehand. The cuffs were loosened in sequence from the buttocks to the thighs and then the calves. During removal, the limbs were closely examined for marks, redness, swelling, or other abnormalities, and the patient was monitored for adverse reactions such as dizziness, palpitations, or muscle soreness, with appropriate measures taken promptly if any issues were identified.

Intervention code：

组别：

联合组

样本量：

 20

Group：

Combination therapy group

Sample size：

干预措施：

1.在常规组基础上予以康复运动太极拳、哑铃操、柔韧平衡操联合体外反搏疗法干预（包括各操的动作标准、训练时长、强度要求等，以及体外反搏的操作方法，均与以上两组保持一致）。 2.康复运动太极拳、哑铃操、柔韧平衡操的干预时间设定为每周一、三、五。体外反搏疗法的干预则覆盖每周一至周五，每天都进行。因此，在每周一、三、五这三天的干预安排中，流程依次为：首先开展心脏康复运动，完成这些运动后，让患者休息至少30分钟，确保身体状态相对平稳，之后再进行体外反搏疗法干预，以保障各项干预措施有序开展且互不干扰，充分发挥各自的作用

干预措施代码：

Intervention：

1. The combination therapy group received an intervention comprising rehabilitative exercises (Tai Chi, dumbbell exercises, and flexibility/balance drills) combined with External Counterpulsation (EECP) therapy, in addition to the routine care given to the conventional group. The specific protocols for the exercises—including movement standards, session duration, and intensity requirements—as well as the EECP operation procedures, were consistent with those detailed in the previous descriptions for the respective standalone groups. 2. The rehabilitative exercises (Tai Chi, dumbbell exercises, and flexibility/balance drills) were scheduled every Monday, Wednesday, and Friday. The EECP therapy sessions were administered daily from Monday to Friday. Therefore, on the overlapping days (Monday, Wednesday, and Friday), the intervention sequence was strictly organized as follows: the cardiac rehabilitation exercises were conducted first. Upon their completion, patients were required to rest for at least 30 minutes to ensure their physiological state had stabilized. Subsequently, the EECP therapy session was initiated. This structured sequence ensured the orderly implementation of all interventions without interference, allowing each modality to exert its therapeutic effect fully.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州 

市(区县)：

 贵阳 

Country：

China

Province：

Guizhou

City：

Guiyang

单位(医院)：

 贵州中医药大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Guizhou University of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

一般资料问卷

指标类型：

主要指标

Outcome：

General Information Questionnaire

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血管内皮功能

指标类型：

主要指标

Outcome：

Vascular Endothelial Function

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心脏指数

指标类型：

主要指标

Outcome：

Cardiac index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脉搏波传导速度

指标类型：

主要指标

Outcome：

Pulse Wave Velocity (PWV)

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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 79 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）：

借助计算机统计软件生成独立的随机数字序列

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

Independent random number sequences were generated with the aid of computer statistical software

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究采用评估者盲的单盲设计

Blinding：

This study used a single-blind design with assessor blinding

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

临床试验公共管理平台http://www.medresman.org.cn/ 2026年12月后（或“研究整体完成后6个月内”）

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

http://www.medresman.org.cn/ After December 2026 (or within 6 months after completion of the entire study)

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.若用病例记录表（CRF）手写+简单电子表格管理，写“采用纸质病例记录表（CRF）采集数据，定期录入[Excel等]电子表格进行管理，无专门EDC系统” 。 2. 若用专业EDC系统（如ResMan ），写“通过基于互联网的EDC系统ResMan进行数据采集和管理，包含病例记录表（CRF）设计、电子数据录入、质量核查等功能，实现数据的规范化采集与管理” 。

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

1. If using handwritten Case Record Forms (CRF) + simple electronic spreadsheet management, write: "Data is collected using paper-based Case Record Forms (CRF) and regularly entered into electronic spreadsheets such as Excel for management. There is no dedicated Electronic Data Capture (EDC) system." 2. If using a professional EDC system (e.g., ResMan), write: "Data collection and management are carried out through the Internet-based

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：

  2026-03-25 10:40:35