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临床试验/NCT07045220
NCT07045220已完成不适用

The Effectiveness of a Transtheoretical Model-based Multidisciplinary Collaboration on Cardiac Rehabilitation Outcomes in Patients With Acute Myocardial Infarction:

RenJi Hospital2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
3-month change of ESSS scores

研究概览

简要总结

Cardiac rehabilitation (CR) has been shown to reduce morbidity and mortality in patients with acute myocardial infarction (AMI), however, the proportion of patients participating in and benefiting from cardiac rehabilitation (CR) remains low in China. This study aims to explore the effects of a trans-theoretical model (TTM)- based multidisciplinary CR program (TTMCR) on behavior change and CR outcomes in AMI patients.

详细描述

We recruited 86 eligible patients hospitalized with AMI were enrolled from a tertiary hospital and allocated into two groups: the intervention group (TTMCR group, n = 43) received TTM-based behavioral stage-matched education, individualized exercise prescription, and ongoing support via a multidisciplinary care team consisting of physicians, nurses, rehabilitation therapists, and cardiac rehabilitation specialists. The control group (n = 41) received standard nursing care and in-hospital CR education without structured follow-up.

The intervention lasted 12 weeks and included pre-discharge assessment and education, individualized home-based exercise prescriptions, telephone follow-ups, social media-based communication (WeChat), and outpatient online consultation support. Outcome measures were assessed at baseline and at 3 months post-discharge. The primary outcomes included objective cardiopulmonary function parameters measured by cardiopulmonary exercise testing (CPET)-specifically anaerobic threshold oxygen consumption per kilogram (AT-VO2/kg) and peak oxygen consumption per kilogram (VO2 Peak/kg)-as well as subjective measures including the Exercise Self-Efficacy Scale (ESES) and the Exercise Social Support Scale (ESSS). The secondary outcome was behavioral change, assessed by weekly exercise frequency and the Stages of Exercise Behavior Change Scale.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 75 years old;
  • Diagnosed with AMI according to the European Society of Cardiology (ESC) guidelines;
  • Received standard PCI and drug treatment in the hospital;
  • Able to communicate effectively with healthcare providers in Mandarin;
  • Long-term residents of Shanghai who had been living in Shanghai for at least 6 months prior to the study and intended to continue residing in Shanghai for the duration of the intervention and follow-up period (3 months);
  • Voluntary participation in the study with signed informed consent;

排除标准

  • Contraindications to cardiac rehabilitation;
  • History of mental disorders;
  • Withdrawal from the study for any reason;
  • Participating in other intervention research projects.

结局指标

主要结局

3-month change of ESSS scores

时间窗: ESSS score of each patient was assessed at baseline and at 3-month follow-up.

Exercise Social Support Scale (ESSS) is a tool used to assess the level of social support individuals perceive related to their exercise habits. In this study, the ESSS score was used as a subjective index to assess the outcomes of cardiac rehabilitation.

3-month change in AT-VO2/kg

时间窗: AT-VO2/kg of each patient was assessed by CPET at baseline and at 3-month follow-up.

Ventilation oxygen at the anaerobic threshold per kilogram (AT-VO2/kg ) reflects the patient's exercise capacity and is an important measurement parameter in CPET. In this study, 3-month change of AT-VO2/kg was used to assess the outcomes of cardiac rehabilitation.

3-month change in VO2 Peak-/kg

时间窗: VO2 Peak-/kg of each patient was assessed by CPET at baseline and at 3-month follow-up.

Peak ventilation oxygen per kilogram (VO2 Peak-/kg) reflects the patient's exercise capacity and is an important measurement parameter in cardiopulmonary exercise testing (CPET). In this study, 3-month change of VO2 Peak-/kg was used to assess the outcomes of cardiac rehabilitation.

3-month change of ESES score

时间窗: ESES score of each patient was assessed at baseline and at 3-month follow-up.

Exercise Self-Efficacy Scale (ESES) was developed to developed by to assess patients' confidence in the ability to participate in exercise and overcome difficulties during exercise. In this study, the ESES score was used as a subjective index to assess the outcomes of cardiac rehabilitation.

3-month change of ESSS scores

时间窗: ESSS score of each patient was assessed at baseline and at 3-month follow-up.

Exercise Social Support Scale (ESSS) is a tool used to assess the level of social support individuals perceive related to their exercise habits. In this study, the ESSS score was used as a subjective index to assess the outcomes of cardiac rehabilitation.

次要结局

  • Weekly exercise frequency(Weekly exercise frequency was assessed at baseline and at 3-month follow-up.)
  • Weekly exercise frequency(Weekly exercise frequency was assessed at baseline and at 3-month follow-up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhiguo Zou

Doctor

RenJi Hospital

研究点 (2)

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