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

NCT ID: NCT07045220

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Standard nursing care and in-hospital CR and routine nursing care was provided for the control group. After clinical assessment, eligible AMI patients received exercise-based in-hospital CR, including lower limb cycle ergometer in bed or on armchair, upper and lower muscle endurance, and 10-60 meters walking. Standard nursing care included patient education on the importance of exercise, suggestions for appropriate exercises based on the disease progression and physiological status, and advises for regular follow-up in the outpatient clinic. After discharge, telephone follow-up was conducted every 1-2 weeks to evaluate the patients' health stat us.

Group Type: NO_INTERVENTION

No interventions assigned to this group

TTMCR group

Patients in the group received a trans-theoretical model (TTM)- based multidisciplinary cardiac rehabilitation program (TTMCR). One day before discharge, physicians, rehabilitation therapists, and nurses jointly developed exercise prescriptions for patients including: exercise frequency, intensity and duration. Nurses and rehabilitation therapists jointly provided patients with cardiac rehabilitation-related health education materials and exercise videos. Physicians recommended that patients use wearable monitoring devices during exercise. After discharge, nurses conducted telephone follow-up once a week for a total of 12 times. The follow-up content mainly included providing sports and medical integration guidance based on the patient's stage of change in exercise behavior.

Group Type: EXPERIMENTAL

TTMCR

Intervention Type: BEHAVIORAL

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

Interventions

TTMCR

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhiguo Zou

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renji Hospital

Shanghai, , China

Countries

China

Other Identifiers

Early Myo-TTMCR

Identifier Type: -

Identifier Source: org_study_id