Clinical trial NCT05201274: Baduanjin Sequential Therapy and Cardiac Function of AMI With Reduced EF After PCI
Official title: Effect of Baduanjin Sequential Therapy on the Cardiac Function and Exercise Endurance in Patients With AMI and Reduced Ejection Fraction After Primary PCI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: AMI
Keywords: Acute myocardial infarction
Baduanjin
Percutaneous coronary intervention
Cardiac function
Physical function
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF)
timeFrame: baseline and 3 months
Secondary outcomes:
measure: SF-36
timeFrame: baseline and 3 months
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: baseline and 3 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: baseline and 3 months
measure: Seattle Angina Questionnaire (SAQ)
timeFrame: baseline and 3 months
measure: Minnesota Satisfaction Questionnaire (MSQ)
timeFrame: baseline and 3 months
measure: Traditional Chinese Medicine (TCM) symptom score scale
timeFrame: baseline and 3 months
measure: CPET operators-Peak VO2/kg
timeFrame: baseline and 3 months
measure: CPET operators-metabolic equivalent (METs)
timeFrame: baseline and 3 months
measure: CPET operators-peak O2-pulse
timeFrame: baseline and 3 months
measure: 6-minute walk distance (6MWD)
timeFrame: baseline and 3 months
measure: Exercise compliance-exercise time
timeFrame: baseline and 3 months
measure: Exercise compliance-Exercise frequency
timeFrame: baseline and 3 months
measure: N-terminal pro-brain natriuretic peptide (NT-pro BNP)
timeFrame: baseline and 3 months
measure: LV end-diastolic volume (LVEDV)
timeFrame: baseline and 3 months
measure: LV end-systolic volume (LVESV)
timeFrame: baseline and 3 months
Other outcomes:
measure: The occurrence and composite of major adverse cardiac and cerebrovascular event (MACCE)
timeFrame: baseline and 3 months
measure: Adverse events related to exercise rehabilitation
timeFrame: baseline and 3 months
Locations:
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Region
state: Liaoning
Study officials:
affiliation: General Hospital of Shenyang Military Region
name: Meili Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.