Methods | Single-centre RCT in Italy; f/u 14 mos | |
Participants | N= 270 (EX n=90; Home n=90; CON n=90) Gender: 67.8% males Mean age: 69 years Diagnosis: post-MI Ethnicity: NR Inclusion: >56 years; referred to unit for functional evaluation 4 to 6 weeks after MI Exclusion: severe cognitive impairment or physical disability, left ventricular EF <35%, contraindications to vigorous physical exercise, eligibility for myocardial revascularization because of low-effort myocardial ischemia, refusal, or living too far from the unit |
|
Interventions | EX: Hospital-CR: program consisted of 40 exercise sessions: 24 sessions (3/wk) of endurance training on cycle ergometer (5-min warm-up, 20-min training at constant workload, 5-min cool down, 5-min post-exercise monitoring) plus 16 (2/wk) 1-hr sessions of stretching and flexibility exercises Home-CR: 4-8 supervised instruction sessions in CR unit, where taught how to perform training at home; then patients received exercise prescription similar to Hosp-CR group CON: no CR, attended single structured session on CV risk factor management with no exercise prescription and were referred back to their family physicians |
|
Outcomes | mortality, MI, CABG, PTCA, HRQL at month 2, 8 and 14 costs over study duration | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Unclear in terms of assessment of outcomes. |
Incomplete outcome data (attrition bias) All outcomes |
High risk | 38 (14.1%) dropped out; clinical event data for these patients not reported per treatment group |
Selective reporting (reporting bias) | Unclear risk | No information reported. |