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

Not Applicable

• Conditions: AMI
• Interventions: Behavioral: Baduanjin sequential therapy; Behavioral: Aerobic exercise

• Registration Number: NCT05201274
• Lead Sponsor: Shenyang Northern Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2021-12-27
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-09
• Last Update Submitted: 2022-01-09
• Study First Posted: 2022-01-21
• Last Update Posted: 2022-01-21
• Primary Completion: 2023-02-11
• Study Completion: 2023-02-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baduanjin sequential therapy	Baduanjin sequential therapy	-
Aerobic exercise	Aerobic exercise	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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)
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)
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)
Exercise compliance-exercise time	baseline and 3 months	Exercise time. (in minutes)
Exercise compliance-Exercise frequency	baseline and 3 months	Exercise frequency. (per week)
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
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.
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.
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.
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)
LV end-systolic volume (LVESV)	baseline and 3 months	The change in echocardiographic measures of ventricular volumes (LV end-systolic volume). LVESV in ml.

Trial Locations

Locations (1)

General Hospital of Shenyang Military Region; 🇨🇳 Shenyang, Liaoning, China