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Status unknownNCT03905187Updated Apr 10, 2019

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

An interventional study of Modified CR and Traditional CR in Acute Myocardial Infarction and Heart Failure, sponsored by Jing Ma. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by Jing Ma · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Myocardial Infarction
  • Heart Failure
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Jing Ma is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
1,200 participants (estimated)

Study arms

  • Other
    Control Group

    Group received education only

    Behavioral: Education

  • Other
    Traditional CR Group

    Group received cardiac rehabilitation including education and exercise

    Behavioral: Traditional CR

  • Experimental
    Stress-Modified CR Group

    Group received cardiac rehabilitation including education, exercise and stress management

    Behavioral: Modified CR

Interventions

  • BehavioralModified CR

    Stress management involved modified cardiac rehabilitation

  • BehavioralTraditional CR

    Traditional cardiac rehabilitation

  • BehavioralEducation

    Education

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 month

  2. 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.

    Time frame: 6 month

  3. 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

    Time frame: 6 month

  4. The score of Chinese perceived stress scale decreased.

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

    Time frame: 6 month

Secondary outcomes

  1. incidence of MACE in patients after acute myocardial infarction

    any incidence of the following: death, cardiac death, AMI, revascularization, stroke

    Time frame: 6 month

  2. incidence of MACE in patients with heart failure

    death, cardiac death, resynchronization

    Time frame: 6 month

  3. improvement of exercise capacity

    6 minute walking distance

    Time frame: 6 month

  4. incidence of rehospitalization

    incidence of rehospitalization

    Time frame: 6 month

07

Study locations

1 site
  • Chinese PLA General Hospital
    Beijing, China
    • Jing Ma · Contact
08

References and documents

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03905187
Lead sponsor
Jing Ma
Responsible party
Jing Ma (Clincial professor, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Apr 5, 2019
Start date
Apr 16, 2019 (estimated)
Primary completion
Sep 1, 2021 (estimated)
Completion
Sep 1, 2021 (estimated)
Last update
Apr 10, 2019

Study contacts

Jing Ma
Contact
crystalma@126.com
+8613681257396
Jing Ma
principal investigator · Department of Cardiology in Chinese PLA General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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