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Clinical Trials/NCT03905187
NCT03905187
Unknown
Not Applicable

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

Jing Ma1 site in 1 country1,200 target enrollmentApril 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Myocardial Infarction
Sponsor
Jing Ma
Enrollment
1200
Locations
1
Primary Endpoint
The score of Chinese perceived stress scale decreased.
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 16, 2019
End Date
September 1, 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jing Ma
Responsible Party
Sponsor Investigator
Principal Investigator

Jing Ma

Clincial professor

Chinese PLA General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

The score of Chinese perceived stress scale decreased.

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 6 month

The score of patient health questionnaire (PHQ9, normal range 0-27,indicating the profile of depression with the higher score) decreased

Secondary Outcomes

  • incidence of MACE in patients with heart failure(6 month)
  • improvement of exercise capacity(6 month)
  • incidence of MACE in patients after acute myocardial infarction(6 month)
  • incidence of rehospitalization(6 month)

Study Sites (1)

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