Effect of Baduanjin Sequential Therapy on the Cardiac Function and Exercise Endurance in Patients With AMI and Reduced Ejection Fraction After Primary PCI
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Left ventricular ejection fraction (LVEF)
Study Overview
Brief Summary
Acute myocardial infarction (AMI) is one of the leading causes of death around the world, with the potential for substantial morbidity and mortality. The increasing evidence indicates that exercise training has beneficial effects on LV remodelling in post-MI patients with greater benefits occurring when training earlier following MI, among which the earliest time for rehabilitation is one week after myocardial infarction. However, the effect of Baduanjin sequential therapy for patients after one week of AMI has yet to be assessed. Therefore, the aim of this study is to assess the impact of Baduanjin sequential therapy on cardiac and physical function in patients with AMI and reduced ejection fraction after primary PCI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute myocardial infarction undergoing primary percutaneous coronary intervention;
- •Aged 18 years or over and under 80 years;
- •35% < LVEF < 50% and LV < 65mm;
- •With informed consents
Exclusion Criteria
- •Severe symptomatic congestive heart failure (KILLIP cardiac function class III-IV);
- •Malignant arrhythmias (ventricular fibrillation, ventricular tachycardia, frequent multiple source ventricular premature);
- •Uncontrolled hypertension (systolic blood pressure greater than 160mmhg, diastolic blood pressure greater than 100mmhg);
- •Life-threatening diseases with limited life expectancy <6 months;
- •Inability or difficulty to exercise;
- •Participation in other clinical trials
Outcomes
Primary Outcomes
Left ventricular ejection fraction (LVEF)
Time Frame: baseline and 3 months
The change in echocardiographic measures of left ventricular ejection fraction，(LVEF). LVEF in %.
Secondary Outcomes
- N-terminal pro-brain natriuretic peptide (NT-pro BNP)(baseline and 3 months)
- Minnesota Satisfaction Questionnaire (MSQ)(baseline and 3 months)
- CPET operators-metabolic equivalent (METs)(baseline and 3 months)
- 6-minute walk distance (6MWD)(baseline and 3 months)
- CPET operators-Peak VO2/kg(baseline and 3 months)
- Exercise compliance-exercise time(baseline and 3 months)
- Exercise compliance-Exercise frequency(baseline and 3 months)
- Generalized Anxiety Disorder 7-item (GAD-7)(baseline and 3 months)
- Patient Health Questionnaire (PHQ-9)(baseline and 3 months)
- Seattle Angina Questionnaire (SAQ)(baseline and 3 months)
- SF-36(baseline and 3 months)
- Traditional Chinese Medicine (TCM) symptom score scale(baseline and 3 months)
- LV end-diastolic volume (LVEDV)(baseline and 3 months)
- CPET operators-peak O2-pulse(baseline and 3 months)
- LV end-systolic volume (LVESV)(baseline and 3 months)
Investigators
Han Yaling
Director of cardiology, General Hospital of Northern Theater Command
Shenyang Northern Hospital