BST-AMI: Baduanjin Sequential Therapy and Cardiac Function of AMI With Reduced EF After PCI
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Baduanjin sequential therapy
|
Behavioral: Baduanjin sequential therapy
A detailed description of a standardized Baduanjin exercise protocol complied with the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003.
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| Active Comparator: Aerobic exercise
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Behavioral: Aerobic exercise
Participants allocated to the usual exercise control group receive a closely supervised, group-format aerobic exercise program located at home or cardiac rehabilitation centre lasting 3 months. The program is consistent with the current recommended guidelines of moderate-intensity exercises for MI.
|
Outcome Measures
Primary Outcome Measures
- Left ventricular ejection fraction (LVEF) [baseline and 3 months]
The change in echocardiographic measures of left ventricular ejection fraction，(LVEF). LVEF in %.
Secondary Outcome Measures
- SF-36 [baseline and 3 months]
the SF-36 has 36 items grouped in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.
- Generalized Anxiety Disorder 7-item (GAD-7) [baseline and 3 months]
The Generalized Anxiety Disorder 7 (GAD-7) is a 7-item instrument used to briefly measure or assess one of the most common mental disorders.
- Patient Health Questionnaire (PHQ-9) [baseline and 3 months]
The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment.
- Seattle Angina Questionnaire (SAQ) [baseline and 3 months]
The Seattle Angina Questionnaire (SAQ), developed by Spertus and first reported in the literature in 1994, increasingly is being used to measure cardiac disease-specific quality of life in patients with CAD and
- Minnesota Satisfaction Questionnaire (MSQ) [baseline and 3 months]
The Minnesota Satisfaction Questionnaire (MSQ) is initially designed to measure an employee's satisfaction with his or her job.
- Traditional Chinese Medicine (TCM) symptom score scale [baseline and 3 months]
Traditional Chinese Medicine (TCM) symptom score scale is a score scale for evaluating patients' symptoms from the perspective of TCM. The full score is 30 points, 7-14 points are mild, 15-22 points are moderate and ≥23 points are severe.
- CPET operators-Peak VO2/kg [baseline and 3 months]
Cardiopulmonary exercise testing ( CPET) is one kind of integrative evaluation of the subject's cardiopulmonary function under a certain exercise load. The information gathered during a CPET is used to calculate Peak VO2 (the highest level of oxygen consumption attained at peak exercise). (ml/kg/min)
- CPET operators-metabolic equivalent (METs) [baseline and 3 months]
In cardiology, and especially when treadmill protocols are used, it is common to express the metabolic requirement for external work as the metabolic equivalent (MET). "MET" is defined as the equivalent of the resting metabolic oxygen requirement. One metabolic equivalent equals 3.5 ml/kg per minute. Exercise capacity (in METS) is a powerful predictor of mortality among men referred for exercise testing. (unit in METs)
- CPET operators-peak O2-pulse [baseline and 3 months]
Another value calculated by CPET is the peak O2-pulse, which indicates how much blood one's heart can pump out with each beat (at the peak level of exercise). (ml/beat)
- 6-minute walk distance (6MWD) [baseline and 3 months]
A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)
- Exercise compliance-exercise time [baseline and 3 months]
Exercise time. (in minutes)
- Exercise compliance-Exercise frequency [baseline and 3 months]
Exercise frequency. (per week)
- N-terminal pro-brain natriuretic peptide (NT-pro BNP) [baseline and 3 months]
N-terminal pro-brain natriuretic peptide (NT-pro BNP) in pg/ml
- LV end-diastolic volume (LVEDV) [baseline and 3 months]
The change in echocardiographic measures of ventricular volumes (LV end-diastolic volume). LVEDV in ml.
- LV end-systolic volume (LVESV) [baseline and 3 months]
The change in echocardiographic measures of ventricular volumes (LV end-systolic volume). LVESV in ml.
Other Outcome Measures
- The occurrence and composite of major adverse cardiac and cerebrovascular event (MACCE) [baseline and 3 months]
defined as recurrent myocardial infarction, any revascularization, readmission, stent thrombosis (ST) all-cause death and stroke)
- Adverse events related to exercise rehabilitation [baseline and 3 months]
Adverse events related to exercise rehabilitation, such as fall.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Acute myocardial infarction undergoing primary percutaneous coronary intervention;
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Aged 18 years or over and under 80 years;
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35% < LVEF < 50% and LV < 65mm;
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With informed consents
Exclusion Criteria:
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Severe symptomatic congestive heart failure (KILLIP cardiac function class III-IV);
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Malignant arrhythmias (ventricular fibrillation, ventricular tachycardia, frequent multiple source ventricular premature);
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Uncontrolled hypertension (systolic blood pressure greater than 160mmhg, diastolic blood pressure greater than 100mmhg);
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Life-threatening diseases with limited life expectancy <6 months;
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Inability or difficulty to exercise;
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Participation in other clinical trials
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General Hospital of Shenyang Military Region | Shenyang | Liaoning | China | 110016 |
Sponsors and Collaborators
- Shenyang Northern Hospital
Investigators
- Principal Investigator: Meili Liu, MD, General Hospital of Shenyang Military Region
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BST-AMI