Methods | Parallel single centre RCT in Italy; 6 month F/U | |
Participants | N=61 (EX n=30; CON n=31) 72.1% male. Mean age: EX=55.9 years; CON=55.1 years Diagnosis: post-infarction Ethnicity: NR Inclusion: acute ST elevation MI Exclusion: residual myocardial ischemia, severe ventricular arrhythmias, AV block, valvular disease requiring surgery, pericarditis, severe renal dysfunction (creatinine >2.5 mg/dL) |
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Interventions | Exercise group: Duration: 6 month; Frequency: 3×/week; Session duration: 30 min; Mode: bicycle ergometer; Intensity: target of60-70% ofVo2 peak achieved at the initial symptom-limited cardiopulmonary exercise test Control group: discharged with generic instructions to maintaining physical activity and a correct lifestyle |
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Outcomes | Fatal/non-fatal MI (6month F/U) | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “randomized” |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | The physician performing all Doppler-echocardiography and cardiopulmonary exercise tests was unaware of the results of blood sampling and was blinded to the patient allocation into the study protocol Unclear in terms of assessment of outcomes. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | All patients were accounted for. |
Selective reporting (reporting bias) | Unclear risk | No information reported. |