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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03905187
• Other study ID #: 301CRS20181228
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: April 2019
• Source: Chinese PLA General Hospital
• Contact: Jing Ma
• Phone: +8613681257396
• Email: crystalma[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• Modified CR
Stress management involved modified cardiac rehabilitation
• Traditional CR
Traditional cardiac rehabilitation
• Education
Education

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jing Ma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	incidence of MACE in patients after acute myocardial infarction	any incidence of the following: death, cardiac death, AMI, revascularization, stroke	6 month
Secondary	incidence of MACE in patients with heart failure	death, cardiac death, resynchronization	6 month
Secondary	improvement of exercise capacity	6 minute walking distance	6 month
Secondary	incidence of rehospitalization	incidence of rehospitalization	6 month