Baduanjin Sequential Therapy and Cardiac Function of AMI With Reduced EF After PCI

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Baduanjin Sequential Therapy on the Cardiac Function and Exercise Endurance in Patients With AMI and Reduced Ejection Fraction After Primary PCI

Conditions
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AMI

Intervention / Treatment
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* Behavioral: Baduanjin sequential therapy
* Behavioral: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baduanjin sequential therapy<br> | Behavioral: Baduanjin sequential therapy<br>* 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.<br>|
| Active Comparator: Aerobic exercise<br> | Behavioral: Aerobic exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (LVEF) | The change in echocardiographic measures of left ventricular ejection fraction，(LVEF). LVEF in %. | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | the SF-36 has 36 items grouped in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health. | baseline and 3 months | 
| Generalized Anxiety Disorder 7-item (GAD-7) | 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. | baseline and 3 months | 
| Patient Health Questionnaire (PHQ-9) | 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. | baseline and 3 months | 
| Seattle Angina Questionnaire (SAQ) | 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 | baseline and 3 months | 
| Minnesota Satisfaction Questionnaire (MSQ) | The Minnesota Satisfaction Questionnaire (MSQ) is initially designed to measure an employee's satisfaction with his or her job. | baseline and 3 months | 
| Traditional Chinese Medicine (TCM) symptom score scale | 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. | baseline and 3 months | 
| CPET operators-Peak VO2/kg | 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) | baseline and 3 months | 
| CPET operators-metabolic equivalent (METs) | 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) | baseline and 3 months | 
| CPET operators-peak O2-pulse | 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) | baseline and 3 months | 
| 6-minute walk distance (6MWD) | A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters) | baseline and 3 months | 
| Exercise compliance-exercise time | Exercise time. (in minutes) | baseline and 3 months | 
| Exercise compliance-Exercise frequency | Exercise frequency. (per week) | baseline and 3 months | 
| N-terminal pro-brain natriuretic peptide (NT-pro BNP) | N-terminal pro-brain natriuretic peptide (NT-pro BNP) in pg/ml | baseline and 3 months | 
| LV end-diastolic volume (LVEDV) | The change in echocardiographic measures of ventricular volumes (LV end-diastolic volume). LVEDV in ml. | baseline and 3 months | 
| LV end-systolic volume (LVESV) | The change in echocardiographic measures of ventricular volumes (LV end-systolic volume). LVESV in ml. | baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Baduanjin, Acute myocardial infarction, Percutaneous coronary intervention, Cardiac function, Physical function