Baduanjin Sequential Therapy and Cardiac Function of AMI With Reduced EF After PCI (BST-AMI)

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

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 Overview

• Status: Recruiting
• Conditions: AMI
• Intervention / Treatment: Behavioral: Baduanjin sequential therapy; Behavioral: Aerobic exercise

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meili Liu, MD; Phone Number: 86-18940193302; Email: liumeili1983bl@163.com
• Study Contact Backup: Name: Yaling Han, MD; Phone Number: 86-24-23922184; Email: hanyaling@163.net

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Recruiting
      • General Hospital of Shenyang Military Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerobic exercise	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.
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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence and composite of major adverse cardiac and cerebrovascular event (MACCE)	defined as recurrent myocardial infarction, any revascularization, readmission, stent thrombosis (ST) all-cause death and stroke)	baseline and 3 months
Adverse events related to exercise rehabilitation	Adverse events related to exercise rehabilitation, such as fall.	baseline and 3 months

Collaborators and Investigators

• Sponsor: Shenyang Northern Hospital
• Investigators: Principal Investigator: Meili Liu, MD, General Hospital of Shenyang Military Region

Publications and helpful links

General Publications

• Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
• Perelshtein Brezinov O, Klempfner R, Zekry SB, Goldenberg I, Kuperstein R. Prognostic value of ejection fraction in patients admitted with acute coronary syndrome: A real world study. Medicine (Baltimore). 2017 Mar;96(9):e6226. doi: 10.1097/MD.0000000000006226.
• Yeh RW, Sidney S, Chandra M, Sorel M, Selby JV, Go AS. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med. 2010 Jun 10;362(23):2155-65. doi: 10.1056/NEJMoa0908610.
• Haykowsky M, Scott J, Esch B, Schopflocher D, Myers J, Paterson I, Warburton D, Jones L, Clark AM. A meta-analysis of the effects of exercise training on left ventricular remodeling following myocardial infarction: start early and go longer for greatest exercise benefits on remodeling. Trials. 2011 Apr 4;12:92. doi: 10.1186/1745-6215-12-92.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Anticipated): February 11, 2023
• Study Completion (Anticipated): February 11, 2023

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 9, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Cardiac function; Acute myocardial infarction; Physical function; Baduanjin
• Other Study ID Numbers: BST-AMI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No