ChiCTR2500100387 版本V1.0 版本创建时间2025/04/08 16:37:20 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：

ChiCTR2500100387 

最近更新日期：

Date of Last Refreshed on：

2025-04-08 16:37:06 

注册时间：

Date of Registration：

2025-04-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于IKAP模式的早期心脏康复方案在急性心肌梗死PCI术后患者中的应用效果随机对照研究

Public title：

Randomized controlled study of the effect of early cardiac rehabilitation program based on IKAP mode in patients after PCI for acute myocardial infarction

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于IKAP模式的早期心脏康复方案在急性心肌梗死PCI术后患者中的应用效果随机对照研究

Scientific title：

Randomized controlled study of the effect of early cardiac rehabilitation program based on IKAP mode in patients after PCI for acute myocardial infarction

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：

陈勉萍 

研究负责人：

赖间清 

Applicant：

Chen MianPing 

Study leader：

Lai JianQing 

申请注册联系人电话：

Applicant telephone：

+86 138 2643 0294

研究负责人电话：

Study leader's telephone：

+86 159 8910 7614

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：

964531872@qq.com

研究负责人电子邮件：

Study leader's E-mail：

787028726@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：

广东省广州市海珠区盈丰路33号中山大学孙逸仙纪念医院

研究负责人通讯地址：

广东省广州市海珠区盈丰路33号中山大学孙逸仙纪念医院

Applicant address：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University, No.33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Provi

Study leader's address：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University, No.33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong 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：

中山大学孙逸仙纪念医院

Applicant's institution：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

研究负责人所在单位：

中山大学孙逸仙纪念医院

Affiliation of the Leader：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

SYSKY-2025-113-02

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：

中山大学孙逸仙纪念医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-04-03 00:00:00

伦理委员会联系人：

区柳珊

Contact Name of the ethic committee：

Ou Liushan

伦理委员会联系地址：

广州市越秀区长堤大马路 171-181 号一方长堤 7 楼 715

Contact Address of the ethic committee：

Room 715, Floor 7, Yifang Long Beach, No.171-181, Changdi Avenue, Yuexiu District, Guangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 8133 2587

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：

中山大学孙逸仙纪念医院

Primary sponsor：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

研究实施负责（组长）单位地址：

广东省广州市海珠区盈丰路33号中山大学孙逸仙纪念医院

Primary sponsor's address：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University, No.33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong 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)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou

单位(医院)：

中山大学孙逸仙纪念医院

具体地址：

广东省广州市海珠区盈丰路33号中山大学孙逸仙纪念医院

Institution
hospital：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Address：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University, No.33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong P

经费或物资来源：

中山大学孙逸仙纪念医院

Source(s) of funding：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Target disease：

Acute myocardial infarction

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：

通过IKAP模式的早期心脏康复在AMI患者PCI术后的开展，研究IKAP模式的心脏康复相较于常规护理在改善AMI患者PCI术后中心功能指标、降低不良心脏事件的发生率、提高生活质量等上的有效性。以IKAP模式为理论框架，构建AMI患者PCI术后早期心脏康复方案，为患者提供个性化疾病管理方案，对患者的生理、心理、行为等方面进行有效干预，制定更全面、系统、科学的心脏康复计划，为AMI患者促进康复及提高生活质量提供更多参考依据。  

Objectives of Study：

Through the implementation of early cardiac rehabilitation using the IKAP model in AMI patients after PCI, this study aims to investigate the effectiveness of IKAP based cardiac rehabilitation compared to conventional nursing in improving central functional indicators, reducing the incidence of adverse cardiac events, and improving quality of life in AMI patients after PCI. Using the IKAP model as the theoretical framework, we construct an early cardiac rehabilitation program for AMI patients after PCI, providing personalized disease management plans for patients, effectively intervening in their physiological, psychological, behavioral, and other aspects, and developing a more comprehensive, systematic, and scientific cardiac rehabilitation plan, providing more reference for AMI patients to promote rehabilitation and improve their quality of life.

药物成份或治疗方案详述：

拟选取中山大学孙逸仙纪念医院2024年12月-2025年11月期间收治的80例急性心肌梗死PCI术后患者作为研究对象，患者均接受常规护理，根据简单随机法分为对照组（40例）与试验组（40例），对照组采用常规护理，试验组在常规护理基础上采用IKAP模式的早期心脏康复进行护理干预。对照组：给予患者常规治疗和护理，包括药物治疗、饮食指导、健康教育、术后康复活动指导等。（1）生命体征监测及病史采集。（2）健康宣教:按医院急性心肌梗死的健康教育路径表进行入院指导、心理指导、疾病知识、检查项目、健康指导（饮食指导、运动指导、药物指导）、出院指导等。 试验组：在对照组的基础上（1）组成心脏康复团队，（2）在对照组的基础上，实施IKAP模式的Ⅰ期心脏康复 I（information收集信息）:入院第1天收集：基本病例收集表及CR风险评估表，基本生活运动能力表，营养风险筛查表，6分钟步行试验，焦虑评估量表（GAD-7量表），抑郁症程度评估量表（PHQ-9量表），尼古丁依赖程度评估表（FTND），心脏病患者运动恐惧量表（TSK-SV Heart），冠心病患者自我效能和自我管理（HH-SESM）量表；入院第1天起，实施心脏康复五大处方知识传授（纸质版资料和视频资料） A（Attitude转变观念）：入院第1起天病情平稳可以开始实施运动处方前，强化宣教内容，多次重复运用教育视频和健康宣教的手册分析患者影响其健康行为的因素，增强患者促进疾病康复的信念。帮助患者和家属现掌握的知识，分析当前健康行为,总结经验教训,培养患者科学心脏康复观念,改变不良生活与饮食习惯,同时取得家属的支持，指导家属应在业余时间与患者共同进行运动康复，增加患者的信心。 P（Practice促使行动）：病情平稳可以实施运动处方：第1步:病情平稳后的1天（床上运动）,桡动脉穿刺者：手部康复训练操：1.用健侧拇指及食指揉捏术侧肢体的手指，从指尖到指跟，再从指跟到指尖，每指10-20秒。2.术侧握拳，从大拇指开始，依次伸开，直至五指完全伸直，再从大拇指开始，依次弯曲，一伸一曲为一次，循环往复，10-20次。3.术侧拇指分别压食指、中指等四指，指尖成拳状，然后食指迅速弹出，伸直，依次进行，再回到拳张璇状，如此反复，10-20次。4.术侧五指屈曲，成握拳状，然后五指放开伸直，握放交替进行，10-20次。5.术侧手指放于平床上，手指向前或向后爬行20-30cm，如此反复，10-20次。6.屈肘运动：仰卧于床上，术侧手平放身侧，握拳，肘关节屈伸5-10次，屈时吸气，伸时呼气，然后平静深呼吸5-10次。股动脉穿刺者：踝泵运动：1.踝关节的屈伸练习：取平卧位，下肢伸直，肌肉放松，缓缓勾起脚尖朝向自己，至最大限度坚持5-10秒后放松；然后脚尖缓缓向下压，至最大限度坚持5-10秒后再放松。2.踝关节的环绕练习：取平卧位，下肢伸展，肌肉放松，以踝关节为中心做360°环绕运动，由内向外或由外向内慢慢地转动，幅度由小到大，速度由慢到快，循环进行。1h/1次。第2步：病情平稳的第2天，桡动脉穿刺者：坐床边、坐椅子：1.双手十指交叉，双臂伸展，吸气时缓慢上举超过头部，呼气回位（重复4-8次）。2.双手十指交叉，双臂伸展，吸气时向左（右）侧方向摆动，呼气回位（重复4-8次）。3.打圈运动训练：吸气时双臂上举，呼气向左（右）侧打圈，吸气回位（重复4-8次）。4.肘关节屈伸训练：双手十指合掌，置于胸前，吸气伸肘，呼气屈肘（重复4-8次）。抬脚运动：吸气双手叉腰，呼气时抬高左（右）脚，脚尖绷直，吸气回位，呼气时抬双腿，脚尖绷直，吸气回位（重复4-8次）。每次10-20分钟,每日2次。股动脉穿刺者：踝泵运动：1.踝关节的屈伸练习：取平卧位，下肢伸直，肌肉放松，缓缓勾起脚尖朝向自己，至最大限度坚持5-10秒后放松；然后脚尖缓缓向下压，至最大限度坚持5-10秒后再放松。2.踝关节的环绕练习：取平卧位，下肢伸展，肌肉放松，以踝关节为中心做360°环绕运动，由内向外或由外向内慢慢地转动，幅度由小到大，速度由慢到快，循环进行。1h/1次。行6分钟步行试验。第3步，病情平稳的第3天：桡动脉穿刺者：下床站立，1.扩胸运动：双手自然下垂，吸气时左（右）脚迈出与肩同宽，双上肢外展扩胸，呼气回位（重复4-8次）。2.左右击掌：吸气时左（右）脚迈出与肩同宽，展开双臂，呼气时身体向左（右）转，右（左）手击左（右）掌，吸气回位（重复4-8次）。3.踢腿运动：吸气时双手叉腰，呼气时左（右）脚踢出，保持脚尖绷直2-3秒，吸气回位（重复4-8次）。4.提踵运动：双手叉腰，吸气提踵，呼气回位（重复4-8次）。5.病房内慢速走动15-25m【慢速：60-90步/分钟】。股动脉穿刺者：坐床边、坐椅子，运动同桡动脉第2天。每次10-20分钟,每日2次。第4步，病情平稳的第4天，桡动脉穿刺者：拉伸训练（热身）1.头颈部拉伸：将头手放在髋部，挺直背部，轻轻抬头看天空，回位，头部向左（右）旋转，回位（重复4-8次）。2.侧肩部拉伸：左（右）臂伸直于胸前，右（左）手臂将左（右）臂朝向身体进行轻压，回位（重复4-8次）。3.躯干侧方拉伸：打开左（右）脚与肩同宽，左（右）手叉腰，右（左）手伸直，身体向左（右）侧髋，回位（重复4-8次）。4.下肢后侧拉伸：左（右）脚向前伸直，脚跟点地，脚尖伸直向上，双手放于腿部，背部挺直，弯腰，尽量将胸部贴近大腿，回位（重复4-8次）。踏车前需进行5-10min的拉伸训练，中速步行25-50m【中速步行90-120步/分钟】或踏车运动20-40W【W指功率】。拉伸训练（放松），原地踏步放松，股动脉穿刺者：下床站立，运动同桡动脉第3天，每次10-20分钟,每日2次。第5步，病情平稳第5天，拉伸训练（热身），踏车运动，拉伸训练（放松），同第4天，每次10-20分钟,每日2次 。第6步，病情平稳第6天，拉伸训练（热身），踏车运动，拉伸训练（放松），同第4天，每次10-20分钟,每日2次。第7步，病情平稳第7天出院，行6分钟步行试验。 

Description for medicine or protocol of treatment in detail：

We plan to select 80 patients with acute myocardial infarction who underwent PCI at Sun Yat sen Memorial Hospital of Sun Yat sen University from December 2024 to November 2025 as the research subjects. All patients received routine care and were randomly divided into a control group (40 cases) and an experimental group (40 cases) according to a simple randomization method. The control group received routine care, while the experimental group received early cardiac rehabilitation intervention based on IKAP mode on the basis of routine care. Control group: Patients were given routine treatment and care, including medication therapy, dietary guidance, health education, postoperative rehabilitation activity guidance, etc. (1) Monitoring of vital signs and collection of medical history. (2) Health education: Provide admission guidance, psychological guidance, disease knowledge, examination items, health guidance (diet guidance, exercise guidance, medication guidance), discharge guidance, etc. according to the hospital's acute myocardial infarction health education pathway table. Experimental group: On the basis of the control group, (1) form a cardiac rehabilitation team, (2) implement the IKAP mode of Phase I cardiac rehabilitation on the basis of the control group. (Information collection): On the first day of admission, collect: basic case collection form and CR risk assessment form, basic life movement ability form, nutritional risk screening form, 6-minute walk test, anxiety assessment scale (GAD-7 scale), depression severity assessment scale (PHQ-9 scale), nicotine dependence assessment scale (FTND), exercise fear scale for heart disease patients (TSK-SV Heart), self-efficacy and self-management scale for coronary heart disease patients (HH-SESM); From the first day of admission, the five major prescription knowledge for cardiac rehabilitation will be taught (paper and video materials) A (Attitude Change Concept): Before starting to implement exercise prescription if the condition is stable on the first day of admission, strengthen the education content, repeatedly use educational videos and health education manuals to analyze the factors that affect the patient's health behavior, and enhance the patient's belief in promoting disease recovery. Assist patients and their families in acquiring current knowledge, analyzing current health behaviors, summarizing lessons learned, cultivating patients' scientific awareness of cardiac rehabilitation, changing unhealthy lifestyles and dietary habits, while gaining support from family members, guiding family members to engage in exercise rehabilitation with patients in their spare time, and increasing patients' confidence. P (Practice drives action): If the condition is stable, exercise prescription can be implemented: Step 1: One day after the condition is stable (bed exercise), radial artery puncture: Hand rehabilitation training exercises: 1. Use the healthy thumb and index finger to knead the fingers of the operated limb, from fingertip to heel, and then from heel to fingertip, for 10-20 seconds per finger. 2. Make a fist on the surgical side, starting from the thumb and extending it one by one until the five fingers are fully extended. Then, starting from the thumb, bend it one by one, repeating the cycle 10-20 times. 3. Press the index finger, middle finger, and other four fingers with the thumb on the surgical side, forming a fist shape with the fingertips. Then quickly pop out the index finger, straighten it out, and repeat the process in sequence, returning to the fist opening shape. Repeat this process 10-20 times. 4. Bend the five fingers on the surgical side into a fist shape, then release and straighten the five fingers, alternating between gripping and releasing 10-20 times. 5. Place the operated finger on a flat bed and crawl it forward or backward by 20-30 cm, repeating this process 10-20 times. 6. Elbow flexion exercise: Lie down on the bed, place the surgical hand flat on the side of the body, make a fist, bend and extend the elbow joint 5-10 times, inhale during flexion, exhale during extension, and then calmly take 5-10 deep breaths. Femoral artery puncture: Ankle pump exercise: 1. Ankle joint flexion and extension exercise: take a supine position, straighten the lower limbs, relax the muscles, slowly lift the toes towards oneself, and hold for 5-10 seconds until the maximum, then relax; Then slowly press down with your toes until it reaches its maximum and lasts for 5-10 seconds before relaxing. 2. Ankle joint wrap around exercise: Take a supine position, stretch the lower limbs, relax the muscles, and perform a 360 ° wrap around motion with the ankle joint as the center. Slowly rotate from the inside out or from the outside in, gradually increasing the amplitude and speed from slow to fast, in a loop. 1 hour/1 time. Step 2: On the second day when the condition is stable, the radial artery puncture should be performed by sitting beside the bed or in a chair: 1. Cross your hands and fingers, stretch your arms, slowly lift them up above your head during inhalation, and exhale and return to their original position (repeated 4-8 times). 2. Cross your fingers and stretch your arms. When inhaling, swing to the left (right) side and exhale back to your original position (repeat 4-8 times). 3. Circular exercise training: Raise both arms while inhaling, exhale and circle to the left (right) side, inhale and return to position (repeat 4-8 times). 4. Elbow joint flexion and extension training: Place the ten fingers of both hands together in front of the chest, inhale and extend the elbow, exhale and bend the elbow (repeat 4-8 times). Foot lifting exercise: Inhale with hands on hips, raise the left (right) foot when exhaling, straighten the toe, inhale back, exhale with legs lifted, straighten the toe, inhale back (repeat 4-8 times). 10-20 minutes each time, twice a day. Femoral artery puncture: Ankle pump exercise: 1. Ankle joint flexion and extension exercise: take a supine position, straighten the lower limbs, relax the muscles, slowly lift the toes towards oneself, and hold for 5-10 seconds until the maximum, then relax; Then slowly press down with your toes until it reaches its maximum and lasts for 5-10 seconds before relaxing. 2. Ankle joint wrap around exercise: Take a supine position, stretch the lower limbs, relax the muscles, and perform a 360 ° wrap around motion with the ankle joint as the center. Slowly rotate from the inside out or from the outside in, gradually increasing the amplitude and speed from slow to fast, in a loop. 1 hour/1 time. Conduct a 6-minute walking test. Step 3, on the third day when the condition is stable: Radial artery puncture patient: get out of bed and stand up. 1. Chest expansion exercise: naturally droop both hands, step out with the left (right) foot shoulder width when inhaling, extend both upper limbs outward to expand the chest, and exhale back (repeat 4-8 times). 2. Left and right high fives: When inhaling, step out with your left (right) foot shoulder width apart, spread your arms, and when exhaling, turn your body to the left (right), strike your left (right) palm with your right (left) hand, and inhale back into place (repeat 4-8 times). 3. Kicking exercise: When inhaling, place your hands on your hips. When exhaling, kick your left (right) foot out and keep your toes straight for 2-3 seconds. Inhale and return to your original position (repeat 4-8 times). 4. Heel lifting exercise: Cross your hands on your hips, inhale to lift your heels, exhale to return to your original position (repeat 4-8 times). 5. Walk slowly in the ward for 15-25m [slow speed: 60-90 steps/minute]. Femoral artery puncture patient: sit by the bed, sit in a chair, and exercise the same as the radial artery on the second day. 10-20 minutes each time, twice a day. Step 4, on the fourth day when the condition is stable, the radial artery puncture operator: Stretching training (warm-up) 1. Head and neck stretching: Place the head and hands on the hips, straighten the back, gently look up at the sky, return to position, rotate the head to the left (right), and return to position (repeat 4-8 times). 2. Side shoulder stretching: Extend the left (right) arm straight in front of the chest, gently press the left (right) arm towards the body with the right (left) arm, and return to its original position (repeat 4-8 times). 3. Lateral trunk stretching: Open the left (right) foot to shoulder width, place the left (right) hand on the waist, extend the right (left) hand, and move the body to the left (right) hip. Return to position (repeat 4-8 times). 4. Stretch the back of the lower limbs: Extend the left (right) foot forward, point the heel on the ground, and extend the toe upwards. Place both hands on the legs, straighten the back, bend over, and try to bring the chest close to the thigh. Return to the original position (repeat 4-8 times). Before cycling, 5-10 minutes of stretching training is required, with moderate speed walking of 25-50m (90-120 steps/minute) or cycling exercise of 20-40W (W refers to power). Stretching training (relaxation), stationary step relaxation, femoral artery puncture: get out of bed and stand up, exercise the same as the radial artery for the third day, 10-20 minutes each time, twice a day. Step 5, on the 5th day of stable condition, stretch training (warm-up), cycling exercise, and stretch training (relaxation), same as on the 4th day, 10-20 minutes each time, twice a day. Step 6, on the 6th day of stable condition, stretch training (warm-up), cycling exercise, and stretch training (relaxation), same as on the 4th day, 10-20 minutes each time, twice a day. Step 7, discharge on the 7th day after the condition stabilizes, and conduct a 6-minute walking test. 

纳入标准：

（1）年龄≥18周岁； （2）符合《2023ESC指南：急性冠脉综合征的管理》中的急性心肌梗死的诊断及治疗标准，并成功接受PCI； （3）具有较高依从性； （4）意识清楚、知情同意并愿意参与本研究者。

Inclusion criteria

1.Age >= 18 years old; 2.Meets the diagnostic and treatment criteria for acute myocardial infarction in the "2023 ESC Guidelines: Management of Acute Coronary Syndrome" and successfully underwent PCI; 3.Has high compliance; 4.Individuals who are aware, have informed consent, and are willing to participate in this study.

排除标准：

(1)病历资料不完整； （2）合并严重的肝脏、脑、肾脏或其他躯体疾病； （3）合并有精神病史或者其他严重并发症； （4）正在参与其他研究。

Exclusion criteria：

1.Incomplete medical records; 2.Merge severe liver, brain, kidney or other physical diseases; 3.Combining a history of mental illness or other serious complications; 4.I am currently involved in other research.

研究实施时间：

Study execute time：

从 From 2024-12-31 00:00:00至 To 2025-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-04-10 00:00:00 至 To 2025-11-23 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

40

Group：

Intervention group

Sample size：

干预措施：

试验组：在对照组的基础上，实施IKAP模式的早期心脏康复 I（information收集信息）:入院第1天收集基本信息；K（Knowledge传授知识）:实施心脏康复五大处方知识传授（纸质版资料和视频资料）；A（Attitude转变观念）：入院3天-病情平稳可以开始实施运动处方前，强化宣教内容，多次重复运用教育视频和健康宣教的手册分析患者影响其健康行为的因素，增强患者促进疾病康复的信念。帮助患者和家属现掌握的知识，分析当前健康行为,总结经验教训,培养患者科学心脏康复观念,改变不良生活与饮食习惯,同时取得家属的支持，指导家属应在业余时间与患者共同进行运动康复，增加患者的信心；P（Practice促使行动）：病情平稳可以实施运动处方-出院（病情允许情况下，循序渐进），实施运动处方：早期心脏康复运动7步法，如下： 第1步:病情平稳后的1天（床上运动）,桡动脉穿刺者：手部康复训练操：1.用健侧拇指及食指揉捏术侧肢体的手指，从指尖到指跟，再从指跟到指尖，每指10-20秒。2.术侧握拳，从大拇指开始，依次伸开，直至五指完全伸直，再从大拇指开始，依次弯曲，一伸一曲为一次，循环往复，10-20次。3.术侧拇指分别压食指、中指等四指，指尖成拳状，然后食指迅速弹出，伸直，依次进行，再回到拳张璇状，如此反复，10-20次。4.术侧五指屈曲，成握拳状，然后五指放开伸直，握放交替进行，10-20次。5.术侧手指放于平床上，手指向前或向后爬行20-30cm，如此反复，10-20次。6.屈肘运动：仰卧于床上，术侧手平放身侧，握拳，肘关节屈伸5-10次，屈时吸气，伸时呼气，然后平静深呼吸5-10次。股动脉穿刺者：踝泵运动：1.踝关节的屈伸练习：取平卧位，下肢伸直，肌肉放松，缓缓勾起脚尖朝向自己，至最大限度坚持5-10秒后放松；然后脚尖缓缓向下压，至最大限度坚持5-10秒后再放松。2.踝关节的环绕练习：取平卧位，下肢伸展，肌肉放松，以踝关节为中心做360°环绕运动，由内向外或由外向内慢慢地转动，幅度由小到大，速度由慢到快，循环进行。1h/1次。第2步：病情平稳的第2天，桡动脉穿刺者：坐床边、坐椅子：1.双手十指交叉，双臂伸展，吸气时缓慢上举超过头部，呼气回位（重复4-8次）。2.双手十指交叉，双臂伸展，吸气时向左（右）侧方向摆动，呼气回位（重复4-8次）。3.打圈运动训练：吸气时双臂上举，呼气向左（右）侧打圈，吸气回位（重复4-8次）。4.肘关节屈伸训练：双手十指合掌，置于胸前，吸气伸肘，呼气屈肘（重复4-8次）。抬脚运动：吸气双手叉腰，呼气时抬高左（右）脚，脚尖绷直，吸气回位，呼气时抬双腿，脚尖绷直，吸气回位（重复4-8次）。每次10-20分钟,每日2次。股动脉穿刺者：踝泵运动：1.踝关节的屈伸练习：取平卧位，下肢伸直，肌肉放松，缓缓勾起脚尖朝向自己，至最大限度坚持5-10秒后放松；然后脚尖缓缓向下压，至最大限度坚持5-10秒后再放松。2.踝关节的环绕练习：取平卧位，下肢伸展，肌肉放松，以踝关节为中心做360°环绕运动，由内向外或由外向内慢慢地转动，幅度由小到大，速度由慢到快，循环进行。1h/1次。行6分钟步行试验。第3步，病情平稳的第3天：桡动脉穿刺者：下床站立，1.扩胸运动：双手自然下垂，吸气时左（右）脚迈出与肩同宽，双上肢外展扩胸，呼气回位（重复4-8次）。2.左右击掌：吸气时左（右）脚迈出与肩同宽，展开双臂，呼气时身体向左（右）转，右（左）手击左（右）掌，吸气回位（重复4-8次）。3.踢腿运动：吸气时双手叉腰，呼气时左（右）脚踢出，保持脚尖绷直2-3秒，吸气回位（重复4-8次）。4.提踵运动：双手叉腰，吸气提踵，呼气回位（重复4-8次）。5.病房内慢速走动15-25m【慢速：60-90步/分钟】。股动脉穿刺者：坐床边、坐椅子，运动同桡动脉第2天。每次10-20分钟,每日2次。第4步，病情平稳的第4天，桡动脉穿刺者：拉伸训练（热身）1.头颈部拉伸：将头手放在髋部，挺直背部，轻轻抬头看天空，回位，头部向左（右）旋转，回位（重复4-8次）。2.侧肩部拉伸：左（右）臂伸直于胸前，右（左）手臂将左（右）臂朝向身体进行轻压，回位（重复4-8次）。3.躯干侧方拉伸：打开左（右）脚与肩同宽，左（右）手叉腰，右（左）手伸直，身体向左（右）侧髋，回位（重复4-8次）。4.下肢后侧拉伸：左（右）脚向前伸直，脚跟点地，脚尖伸直向上，双手放于腿部，背部挺直，弯腰，尽量将胸部贴近大腿，回位（重复4-8次）。踏车前需进行5-10min的拉伸训练，中速步行25-50m【中速步行90-120步/分钟】或踏车运动20-40W【W指功率】。拉伸训练（放松），原地踏步放松，股动脉穿刺者：下床站立，运动同桡动脉第3天，每次10-20分钟,每日2次。第5步，病情平稳第5天，拉伸训练（热身），踏车运动，拉伸训练（放松），同第4天，每次10-20分钟,每日2次 。第6步，病情平稳第6天，拉伸训练（热身），踏车运动，拉伸训练（放松），同第4天，每次10-20分钟,每日2次。第7步，病情平稳第7天出院，行6分钟步行试验。

干预措施代码：

Intervention：

Experimental group: Early cardiac rehabilitation using IKAP mode on the basis of the control group I (Information Collection): Collect basic information on the first day of admission; K (Knowledge transmission): Implementing the five major prescriptions for cardiac rehabilitation knowledge transmission (paper and video materials); A (Attitude Change Concept): After 3 days of hospitalization, if the condition is stable, before implementing the exercise prescription, strengthen the educational content, repeatedly use educational videos and health education manuals to analyze the factors that affect the patient's health behavior, and enhance the patient's belief in promoting disease recovery. Assist patients and their families in mastering current knowledge, analyzing current health behaviors, summarizing experiences and lessons, cultivating patients' scientific concept of cardiac rehabilitation, changing unhealthy lifestyles and dietary habits, while gaining support from their families, guiding them to engage in exercise rehabilitation with patients in their spare time, and increasing patients' confidence; P (Practice drives action): If the condition is stable, exercise prescription can be implemented and discharged (gradually if the condition allows). Exercise prescription: Early cardiac rehabilitation exercise 7-step method, as follows: Step 1: One day after the condition stabilizes (bed exercise), for radial artery puncture patients: Hand rehabilitation training exercises: 1. Use the healthy thumb and index finger to knead the fingers of the operated limb, from fingertip to heel, and then from heel to fingertip, for 10-20 seconds per finger. 2. Make a fist on the surgical side, starting from the thumb and extending it one by one until the five fingers are fully extended. Then, starting from the thumb, bend it one by one, repeating the cycle 10-20 times. 3. Press the index finger, middle finger, and other four fingers with the thumb on the surgical side, forming a fist shape with the fingertips. Then quickly pop out the index finger, straighten it out, and repeat the process in sequence, returning to the fist opening shape. Repeat this process 10-20 times. 4. Bend the five fingers on the surgical side into a fist shape, then release and straighten the five fingers, alternating between gripping and releasing 10-20 times. 5. Place the operated finger on a flat bed and crawl it forward or backward by 20-30 cm, repeating this process 10-20 times. 6. Elbow flexion exercise: Lie down on the bed, place the surgical hand flat on the side of the body, make a fist, bend and extend the elbow joint 5-10 times, inhale during flexion, exhale during extension, and then calmly take 5-10 deep breaths. Femoral artery puncture: Ankle pump exercise: 1. Ankle joint flexion and extension exercise: take a supine position, straighten the lower limbs, relax the muscles, slowly lift the toes towards oneself, and hold for 5-10 seconds until the maximum, then relax; Then slowly press down with your toes until it reaches its maximum and lasts for 5-10 seconds before relaxing. 2. Ankle joint wrap around exercise: Take a supine position, stretch the lower limbs, relax the muscles, and perform a 360 ° wrap around motion with the ankle joint as the center. Slowly rotate from the inside out or from the outside in, gradually increasing the amplitude and speed from slow to fast, in a loop. 1 hour/1 time. Step 2: On the second day when the condition is stable, the radial artery puncture should be performed by sitting beside the bed or in a chair: 1. Cross your hands and fingers, stretch your arms, slowly lift them up above your head during inhalation, and exhale and return to their original position (repeated 4-8 times). 2. Cross your fingers and stretch your arms. When inhaling, swing to the left (right) side and exhale back to your original position (repeat 4-8 times). 3. Circular exercise training: Raise both arms while inhaling, exhale and circle to the left (right) side, inhale and return to position (repeat 4-8 times). 4. Elbow joint flexion and extension training: Place the ten fingers of both hands together in front of the chest, inhale and extend the elbow, exhale and bend the elbow (repeat 4-8 times). Foot lifting exercise: Inhale with hands on hips, raise the left (right) foot when exhaling, straighten the toe, inhale back, exhale with legs lifted, straighten the toe, inhale back (repeat 4-8 times). 10-20 minutes each time, twice a day. Femoral artery puncture: Ankle pump exercise: 1. Ankle joint flexion and extension exercise: take a supine position, straighten the lower limbs, relax the muscles, slowly lift the toes towards oneself, and hold for 5-10 seconds until the maximum, then relax; Then slowly press down with your toes until it reaches its maximum and lasts for 5-10 seconds before relaxing. 2. Ankle joint wrap around exercise: Take a supine position, stretch the lower limbs, relax the muscles, and perform a 360 ° wrap around motion with the ankle joint as the center. Slowly rotate from the inside out or from the outside in, gradually increasing the amplitude and speed from slow to fast, in a loop. 1 hour/1 time. Conduct a 6-minute walking test. Step 3, on the third day when the condition is stable: Radial artery puncture patient: get out of bed and stand up. 1. Chest expansion exercise: naturally droop both hands, step out with the left (right) foot shoulder width when inhaling, extend both upper limbs outward to expand the chest, and exhale back (repeat 4-8 times). 2. Left and right high fives: When inhaling, step out with your left (right) foot shoulder width apart, spread your arms, and when exhaling, turn your body to the left (right), strike your left (right) palm with your right (left) hand, and inhale back into place (repeat 4-8 times). 3. Kicking exercise: When inhaling, place your hands on your hips. When exhaling, kick your left (right) foot out and keep your toes straight for 2-3 seconds. Inhale and return to your original position (repeat 4-8 times). 4. Heel lifting exercise: Cross your hands on your hips, inhale to lift your heels, exhale to return to your original position (repeat 4-8 times). 5. Walk slowly in the ward for 15-25m [slow speed: 60-90 steps/minute]. Femoral artery puncture patient: sit by the bed, sit in a chair, and exercise the same as the radial artery on the second day. 10-20 minutes each time, twice a day. Step 4, on the fourth day when the condition is stable, the radial artery puncture operator: Stretching training (warm-up) 1. Head and neck stretching: Place the head and hands on the hips, straighten the back, gently look up at the sky, return to position, rotate the head to the left (right), and return to position (repeat 4-8 times). 2. Side shoulder stretching: Extend the left (right) arm straight in front of the chest, gently press the left (right) arm towards the body with the right (left) arm, and return to its original position (repeat 4-8 times). 3. Lateral trunk stretching: Open the left (right) foot to shoulder width, place the left (right) hand on the waist, extend the right (left) hand, and move the body to the left (right) hip. Return to position (repeat 4-8 times). 4. Stretch the back of the lower limbs: Extend the left (right) foot forward, point the heel on the ground, and extend the toe upwards. Place both hands on the legs, straighten the back, bend over, and try to bring the chest close to the thigh. Return to the original position (repeat 4-8 times). Before cycling, 5-10 minutes of stretching training is required, with moderate speed walking of 25-50m (90-120 steps/minute) or cycling exercise of 20-40W (W refers to power). Stretching training (relaxation), stationary step relaxation, femoral artery puncture: get out of bed and stand up, exercise the same as the radial artery for the third day, 10-20 minutes each time, twice a day. Step 5, on the 5th day of stable condition, stretch training (warm-up), cycling exercise, and stretch training (relaxation), same as on the 4th day, 10-20 minutes each time, twice a day. Step 6, on the 6th day of stable condition, stretch training (warm-up), cycling exercise, and stretch training (relaxation), same as on the 4th day, 10-20 minutes each time, twice a day. Step 7, discharge on the 7th day after the condition stabilizes, and conduct a 6-minute walking test.

Intervention code：

组别：

对照组

样本量：

40

Group：

Control group

Sample size：

干预措施：

给予患者常规治疗和护理，包括药物治疗、饮食指导、出入量控制、健康教育、康复活动指导等。（1）生命体征监测及病史采集。（2）健康宣教:按医院急性心肌梗死健康教育路径表进行入院指导、心理指导、疾病知识指导、检查项目指导、健康指导（饮食指导、运动指导、药物指导）、出院指导等。

干预措施代码：

Intervention：

Routine treatment and nursing care are provided to patients, including medication, dietary guidance, intake and exit control, health education, and rehabilitation activity guidance. (1) Vital signs monitoring and medical history collection. (2) Health education: according to the hospital's acute myocardial infarction health education pathway table, admission guidance, psychological guidance, disease knowledge guidance, examination item guidance, health guidance (diet guidance, exercise guidance, drug guidance), discharge guidance, etc.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China 

Province：

Guangdong Province 

City：

Guangzhou 

单位(医院)：

中山大学孙逸仙纪念医院 

单位级别：

三甲 

Institution
hospital：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

6分钟步行试验

指标类型：

主要指标

Outcome：

6-minute walking distance

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：

无

组织：

Sample Name：

NA

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 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）：

使用简单随机法，按入院顺序随机分为对照组和干预组。

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

Using simple random method, they were randomly divided into control group and intervention group according to the order of admission.

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：

对评估者及数据分析者隐藏分组。

Blinding：

Hide groupings for evaluators and data analysts.

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

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)：

NA

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.对临床试验研究中符合纳排标准的研究对象的情况进行调查，收集资料包括基本病例收集表及CR风险评估表、基本生活运动能力评分、营养风险筛查评分、6分钟步行试验、焦虑评估量表评分、抑郁症程度评估量表评分、尼古丁依赖程度评估表评分、心脏病患者运动恐惧量表评分、冠心病患者自我效能和自我管理（HH-SESM）量表评分。 2.将收集到的数据录入 Excel表格，应用SPSS26.0软件进行数据分析。计量资料以均数±标准差表示。对于符合正态分布的计量资料，两组间比较采用两独立样本t检验，对于不符合正态分布的计量资料，两组间比较采用秩和检验。计数资料以频数和率表示，采用卡方检验进行比较，以P<0.05为差异有统计学意义。

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

1. Investigate the situation of research subjects who meet the inclusion and exclusion criteria in clinical trial studies, and collect data including basic case collection form and CR risk assessment form, basic life exercise ability score, nutritional risk screening score, 6-minute walk test, anxiety assessment scale score, depression severity assessment scale score, nicotine dependence assessment scale score, heart disease patient exercise fear scale score, and coronary heart disease patient self-efficacy and self-management (HH-SESM) scale score. 2. Enter the collected data into an Excel spreadsheet and use SPSS 26.0 software for data analysis. Measurement data is expressed as mean ± standard deviation. For metric data that follows a normal distribution, a two independent sample t-test is used for comparison between two groups. For metric data that does not follow a normal distribution, a rank sum test is used for comparison between two groups. Count data are expressed in frequency and rate, and chi square test is used for comparison. P<0.05 is considered statistically significant.

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：

  2025-04-08 16:37:06