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

NCT07045220 | Completed

• 1 other identifier: Early Myo-TTMCR
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (4)

• 3-month change in VO2 Peak-/kg

  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.

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

• 3-month change in AT-VO2/kg

  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.

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

• 3-month change of ESES score

  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.

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

• 3-month change of ESSS scores

  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.

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

Secondary Outcomes (1)

• Weekly exercise frequency

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

Study Arms (2)

Control

NO INTERVENTION

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.

TTMCR group

EXPERIMENTAL

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.

Behavioral: TTMCR

Interventions

TTMCR BEHAVIORAL

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

TTMCR group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 1, 2025
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)