Acute Myocardial Infarction, Heart Failure
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALModified CR
Stress management involved modified cardiac rehabilitation
BEHAVIORALTraditional CR
Traditional cardiac rehabilitation
BEHAVIORALEducation
Education
Sponsors
Jing Ma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The score of Chinese perceived stress scale decreased. | 6 month | The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased. |
| The score of anxiety test questionnaire decreased | 6 month | 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 |
| The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased | 6 month | 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. |
| The score of patient health questionnaire decreased | 6 month | The score of patient health questionnaire (PHQ9, normal range 0-27，indicating the profile of depression with the higher score) decreased |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of MACE in patients after acute myocardial infarction | 6 month | any incidence of the following: death, cardiac death, AMI, revascularization, stroke |
| incidence of MACE in patients with heart failure | 6 month | death, cardiac death, resynchronization |
| improvement of exercise capacity | 6 month | 6 minute walking distance |
| incidence of rehospitalization | 6 month | incidence of rehospitalization |
Countries
China
Contacts
Primary ContactJing Ma
Outcome results
None listed