Study Design and Population
This was a prospective, longitudinal, randomized and controlled study.
Patients with uncomplicated AMI admitted to the Acute Coronary Disease
Unit of the Heart Institute of the Sao Paulo Medical School
(InCor/HCFMUSP), who agreed to participate in the study, were randomized
to 2 groups (TRAINING and CONTROL), in the proportion 1:1 according to
the following protocol: Time 0 : still hospitalized, all patients,
after due explanations, signed the informed consent for inclusion in the
study. Time 1 : all participants returned 1 month after AMI and
were submitted to a 2D-STE echocardiogram and cardiopulmonary exercising
testing (CPX). After this, participants randomized to the TRAINING group
were included in a weekly supervised physical training program, twice a
week, for 4 months, at the Rehabilitation Lab, while individuals
randomized to the CONTROL group received usual recommendations for
physical activity at home. Time 2 : at the end of the fourth month
(5th month after the AMI event), all patients repeated
2D-STE echo and CPX. This design is provided in the Supplementary Data
I.
Inclusion criteria were: age over 18; hospitalization for spontaneous
AMI with or without ST-segment elevation, established according to the
3rd Universal Definition of AMI26;
clinically and hemodynamically stable; left ventricular ejection
fraction (LVEF) ≥ 0.45 and Killip classes I or II. The exclusion
criteria were: any condition that contraindicated physical activity;
regular physical activity practitioners prior to the event; LV systolic
dysfunction (LVEF < 45%); Killip classes III or IV; irregular
heart rhythm; cardiac pacemaker; chronic kidney disease characterized by
creatinine clearance < 30 ml/min/m2; limited
echocardiographic window for analysis.
The present protocol was in accordance with the recommendations
contained in the Declaration of Helsinki and was approved by the
institutional Scientific and Ethics committees. All the patients signed
the informed consent form before inclusion in this protocol.