Stress Management Modified Cardiac Rehabilitation in Patients After Acute Myocardial Infarction or Heart Failure

Study Overview
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Brief Summary
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The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure.

Detailed Description
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The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure. The investigators performed modified cardiac rehabilitation program involving stress management on the patients who suffered from acute myocardial infarction or severe heart failure who were admitted to the CCU. Then the psychological states, quality of life and clinical outcomes were followed up.

Official Title
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A Perspective Randomized Study of Impact of Stress Management Involved Cardiac Rehabilitation on Psychological States and Clinical Outcomes of Patients After Acute Myocardial Infarction or Heart Failure

Conditions
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Acute Myocardial Infarction, Heart Failure

Intervention / Treatment
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* Behavioral: Modified CR
* Behavioral: Traditional CR
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-80 years old with a diagnosis of AMI (include ST segment elevated myocardial infarction and non-ST segment elevated myocardial infarction) or heart failure Exclusion Criteria: Uncontrolled tachycardia (heart rate at rest >120bpm Uncontrolled polypnea（breath rate at rest >30 breath per minute Uncontrolled respiratory failure （SPO2 ≤90%） Uncontrolled hypertension （pre-exercise SBP>180mmHg or DBP>110mmHg） Weight change in 72 hours >1.8kg Uncontrolled hyperglycemia (Random blood glucose>18mmol/L) Uncontrolled malignant arrhythmia with hemodynamic instability Unoperated pseudoaneurysm、artery dissection Uncontrolled septic shock and septicopyemia Unoperated severe valvular heart disease or acute phase of heart failure caused by myocardial heart disease nervous system disease, motor system diseases and rheumatic diseases considered possibly worsened by exercise Uncooperation of the patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>Group received education only | Behavioral: Education<br>* Education<br>|
| Other: Traditional CR Group<br>Group received cardiac rehabilitation including education and exercise | Behavioral: Traditional CR<br>* Traditional cardiac rehabilitation<br>|
| Experimental: Stress-Modified CR Group<br>Group received cardiac rehabilitation including education, exercise and stress management | Behavioral: Modified CR<br>* Stress management involved modified cardiac rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The score of anxiety test questionnaire decreased | The score of anxiety test questionnaire(Generalized Anxiety Disorder,GAD-7, normal range 0-21, partially reflecting the severity of anxiety with the higher score) decreased | 6 month | 
| The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased | The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (abbreviation form is 36-Item Short Form Survey) increased. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability, The sections consists of Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, and Mental health. The total score of SF 36 Health survey is higher, the quality of life is higher. | 6 month | 
| The score of patient health questionnaire decreased | The score of patient health questionnaire (PHQ9, normal range 0-27，indicating the profile of depression with the higher score) decreased | 6 month | 
| The score of Chinese perceived stress scale decreased. | The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of MACE in patients after acute myocardial infarction | any incidence of the following: death, cardiac death, AMI, revascularization, stroke | 6 month | 
| incidence of MACE in patients with heart failure | death, cardiac death, resynchronization | 6 month | 
| improvement of exercise capacity | 6 minute walking distance | 6 month | 
| incidence of rehospitalization | incidence of rehospitalization | 6 month |