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NCT Number: NCT07045220

The Effectiveness of a TTM-based Multidisciplinary Collaboration on Cardiac Rehabilitation Outcomes in Patients With AMI

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital

Shanghai, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

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

Treatment and study plan

TTMCR

Behavioral

A trans-theoretical model (TTM)- based multidisciplinary CR program (TTMCR) to improve behavior change and cardiac rehabilitation outcomes

Primary outcomes

  1. 3-month change in VO2 Peak-/kg

    Time frame: 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.

  2. 3-month change in AT-VO2/kg

    Time frame: 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. 3-month change of ESES score

    Time frame: 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.

  4. 3-month change of ESSS scores

    Time frame: 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.

Secondary outcomes

  1. Weekly exercise frequency

    Time frame: Weekly exercise frequency was assessed at baseline and at 3-month follow-up.

    Weekly exercise frequency refers to the number of times a patient engages in structured physical activity (aerobic or resistance exercise) lasting at least 30 minutes per session, within a 7-day period. In this study, the change in weekly exercise frequency was evaluated to determine the effects of treatments on behavior change.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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