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

Jing Ma

Status: Unknown

Conditions: Heart Failure; Acute Myocardial Infarction

Treatments: Behavioral: Traditional CR; Behavioral: Education; Behavioral: Modified CR

Study type: Interventional

Funder types: Other

Identifiers

NCT03905187

301CRS20181228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,200 participants in 3 patient groups

Control Group

Other group

Description:

Group received education only

Treatment:

Behavioral: Education

Traditional CR Group

Other group

Description:

Group received cardiac rehabilitation including education and exercise

Treatment:

Behavioral: Traditional CR

Stress-Modified CR Group

Experimental group

Description:

Group received cardiac rehabilitation including education, exercise and stress management

Treatment:

Behavioral: Modified CR