NCT03905187

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

April 16, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

2.4 years

First QC Date

February 3, 2019

Last Update Submit

April 8, 2019

Conditions

Acute Myocardial InfarctionHeart Failure

Outcome Measures

Primary Outcomes (4)

  • 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

    6 month

  • 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.

    6 month

  • 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

    6 month

  • The score of Chinese perceived stress scale decreased.

    The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.

    6 month

Secondary Outcomes (4)

  • incidence of MACE in patients after acute myocardial infarction

    6 month

  • incidence of MACE in patients with heart failure

    6 month

  • improvement of exercise capacity

    6 month

  • incidence of rehospitalization

    6 month

Study Arms (3)

Control Group

OTHER

Group received education only

Behavioral: Education

Traditional CR Group

OTHER

Group received cardiac rehabilitation including education and exercise

Behavioral: Traditional CR

Stress-Modified CR Group

EXPERIMENTAL

Group received cardiac rehabilitation including education, exercise and stress management

Behavioral: Modified CR

Interventions

Modified CRBEHAVIORAL

Stress management involved modified cardiac rehabilitation

Stress-Modified CR Group
Traditional CRBEHAVIORAL

Traditional cardiac rehabilitation

Traditional CR Group
EducationBEHAVIORAL

Education

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Jing Ma

    Department of Cardiology in Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Ma

CONTACT

+8613681257396crystalma@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clincial professor

Study Record Dates

First Submitted

February 3, 2019

First Posted

April 5, 2019

Study Start

April 16, 2019

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

April 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations

CN(1)