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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03905187
Recruitment Status : Unknown
Verified April 2019 by Jing Ma, Chinese PLA General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 5, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Jing Ma, Chinese PLA General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Heart Failure Behavioral: Modified CR Behavioral: Traditional CR Behavioral: Education Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 16, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Control Group
Group received education only
 Behavioral: Education
Education
Traditional CR Group
Group received cardiac rehabilitation including education and exercise
 Behavioral: Traditional CR
Traditional cardiac rehabilitation
Experimental: Stress-Modified CR Group
Group received cardiac rehabilitation including education, exercise and stress management
 Behavioral: Modified CR
Stress management involved modified cardiac rehabilitation


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. incidence of MACE in patients after acute myocardial infarction [ Time Frame: 6 month ]
    any incidence of the following: death, cardiac death, AMI, revascularization, stroke

  2. incidence of MACE in patients with heart failure [ Time Frame: 6 month ]
    death, cardiac death, resynchronization

  3. improvement of exercise capacity [ Time Frame: 6 month ]
    6 minute walking distance

  4. incidence of rehospitalization [ Time Frame: 6 month ]
    incidence of rehospitalization


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • nervous system disease, motor system diseases and rheumatic diseases considered possibly worsened by exercise
  • Uncooperation of the patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905187


Contacts
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Contact: Jing Ma +8613681257396 crystalma@126.com

Locations
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China
Chinese PLA General Hospital
Beijing, China
Contact: Jing Ma         
Sponsors and Collaborators
Jing Ma
Investigators
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Principal Investigator: Jing Ma Department of Cardiology in Chinese PLA General Hospital
More Information
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Responsible Party: Jing Ma, Clincial professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03905187    
Other Study ID Numbers: 301CRS20181228
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: starting 6 months after publication
Access Criteria: The IPD of the publication will be shared, including characteristic data, results, clinical follow up data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
 Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases