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

April 8, 2019 updated by: Jing Ma

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Control Group
Group received education only
Behavioral: Education
Education
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 month
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.
6 month
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
6 month
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.
6 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jing Ma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 16, 2019

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

February 3, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (ACTUAL)

April 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301CRS20181228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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