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. Author manuscript; available in PMC: 2014 Nov 13.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2
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.