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

NCT ID: NCT03905187

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-16

Study Completion Date

2021-09-01

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control Group

Group received education only

Group Type OTHER

Education

Intervention Type BEHAVIORAL

Education

Traditional CR Group

Group received cardiac rehabilitation including education and exercise

Group Type OTHER

Traditional CR

Intervention Type BEHAVIORAL

Traditional cardiac rehabilitation

Stress-Modified CR Group

Group received cardiac rehabilitation including education, exercise and stress management

Group Type EXPERIMENTAL

Modified CR

Intervention Type BEHAVIORAL

Stress management involved modified cardiac rehabilitation

Interventions

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Modified CR

Stress management involved modified cardiac rehabilitation

Intervention Type BEHAVIORAL

Traditional CR

Traditional cardiac rehabilitation

Intervention Type BEHAVIORAL

Education

Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jing Ma

OTHER

Sponsor Role lead

Responsible Party

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Jing Ma

Clincial professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jing Ma

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology in Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Jing Ma

Role: CONTACT

+8613681257396

Facility Contacts

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Jing Ma

Role: primary

Other Identifiers

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301CRS20181228

Identifier Type: -

Identifier Source: org_study_id

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