Acute Myocardial InfarctionNCT07045220
The Effectiveness of a TTM-based Multidisciplinary Collaboration on Cardiac Rehabilitation Outcomes in Patients With AMI
A study testing TTMCR in people with Acute Myocardial Infarction, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- TTMCR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Contraindications to cardiac rehabilitation;
- History of mental disorders;
- Withdrawal from the study for any reason;
- Participating in other intervention research projects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Transtheoretical Model-based Multidisciplinary Collaboration on Cardiac Rehabilitation Outcomes in Patients With Acute Myocardial Infarction：
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.
Read the 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
- Being tested
- TTMCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTMCRBehavioural
A trans-theoretical model (TTM)- based multidisciplinary CR program (TTMCR) to improve behavior change and cardiac rehabilitation outcomes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: TTMCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: ESSS score of each patient was assessed at baseline and at 3-month follow-up.
Secondary outcomes (1)
Weekly exercise frequency
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.
Measured: Weekly exercise frequency was assessed at baseline and at 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Zou, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045220
- Sponsor's protocol ID
- Early Myo-TTMCR
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Transtheoretical Model-based Multidisciplinary Collaboration on Cardiac Rehabilitation Outcomes in Patients With Acute Myocardial Infarction：
- ClinicalTrials.gov ID
- NCT07045220
- Acronym / sponsor ID
- Early Myo-TTMCR
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: TTMCRPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (4 listed)
- Contraindications to cardiac rehabilitation;
- History of mental disorders;
- Withdrawal from the study for any reason;
- Participating in other intervention research projects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTMCRA trans-theoretical model (TTM)- based multidisciplinary CR program (TTMCR) to improve behavior change and cardiac rehabilitation outcomes | Behavioural | TTMCR group |
Primary outcome
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.
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-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.
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.
1 secondary outcome
Weekly exercise frequency
Time frame: Weekly exercise frequency was assessed at baseline and at 3-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTMCR in people with Acute Myocardial Infarction, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.