Back to resultsStress Management Modified Cardiac Rehabilitation in Patients After Acute Myocardial Infarction or Heart Failure
Primary Purpose
Acute Myocardial Infarction, Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified CR
Traditional CR
Education
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
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
- nervous system disease, motor system diseases and rheumatic diseases considered possibly worsened by exercise
- Uncooperation of the patients
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Experimental
Arm Label
Control Group
Traditional CR Group
Stress-Modified CR Group
Arm Description
Group received education only
Group received cardiac rehabilitation including education and exercise
Group received cardiac rehabilitation including education, exercise and stress management
Outcomes
Primary Outcome Measures
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
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.
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
The score of Chinese perceived stress scale decreased.
The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.
Secondary Outcome Measures
incidence of MACE in patients after acute myocardial infarction
any incidence of the following: death, cardiac death, AMI, revascularization, stroke
incidence of MACE in patients with heart failure
death, cardiac death, resynchronization
improvement of exercise capacity
6 minute walking distance
incidence of rehospitalization
incidence of rehospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03905187
Brief Title
Stress Management Modified Cardiac Rehabilitation in Patients After Acute Myocardial Infarction or Heart Failure
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2019 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jing Ma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Other
Arm Description
Group received education only
Arm Title
Traditional CR Group
Arm Type
Other
Arm Description
Group received cardiac rehabilitation including education and exercise
Arm Title
Stress-Modified CR Group
Arm Type
Experimental
Arm Description
Group received cardiac rehabilitation including education, exercise and stress management
Intervention Type
Behavioral
Intervention Name(s)
Modified CR
Intervention Description
Stress management involved modified cardiac rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Traditional CR
Intervention Description
Traditional cardiac rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Education
Primary Outcome Measure Information:
Title
The score of anxiety test questionnaire decreased
Description
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
Time Frame
6 month
Title
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased
Description
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.
Time Frame
6 month
Title
The score of patient health questionnaire decreased
Description
The score of patient health questionnaire (PHQ9, normal range 0-27，indicating the profile of depression with the higher score) decreased
Time Frame
6 month
Title
The score of Chinese perceived stress scale decreased.
Description
The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
incidence of MACE in patients after acute myocardial infarction
Description
any incidence of the following: death, cardiac death, AMI, revascularization, stroke
Time Frame
6 month
Title
incidence of MACE in patients with heart failure
Description
death, cardiac death, resynchronization
Time Frame
6 month
Title
improvement of exercise capacity
Description
6 minute walking distance
Time Frame
6 month
Title
incidence of rehospitalization
Description
incidence of rehospitalization
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
nervous system disease, motor system diseases and rheumatic diseases considered possibly worsened by exercise
Uncooperation of the patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Ma
Phone
+8613681257396
Email
crystalma@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Ma
Organizational Affiliation
Department of Cardiology in Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Ma
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
The IPD of the publication will be shared, including characteristic data, results, clinical follow up data.
Learn more about this trial
Stress Management Modified Cardiac Rehabilitation in Patients After Acute Myocardial Infarction or Heart Failure
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