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

Not Applicable

• Conditions: Heart Failure; Acute Myocardial Infarction
• Interventions: Behavioral: Traditional CR; Behavioral: Modified CR; Behavioral: Education

• Registration Number: NCT03905187
• Lead Sponsor: Jing Ma

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.

Study Timeline

• Study First Submitted: 2019-02-03
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-05
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10
• Study Start: 2019-04-16
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional CR Group	Traditional CR	Group received cardiac rehabilitation including education and exercise
Stress-Modified CR Group	Modified CR	Group received cardiac rehabilitation including education, exercise and stress management
Control Group	Education	Group received education only

Primary Outcome Measures

Name	Time	Method
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 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 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 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 Outcome Measures

Name	Time	Method
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 MACE in patients after acute myocardial infarction	6 month	any incidence of the following: death, cardiac death, AMI, revascularization, stroke
incidence of rehospitalization	6 month	incidence of rehospitalization

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China