Marchionni 2003.

Methods	Study design: Single centre RCT Country: Italy Dates patients recruited: NR (48 month period) Maximum follow up: 14 months
Participants	Inclusion criteria: > 56 years; referred to unit for functional evaluation 4 to 6 weeks after MI. Exclusion criteria: 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. N Randomised: total: 270; intervention: 90; home: 90; comparator: 90 Diagnosis (% of pts): MI: 100% Age (mean [range]): 69 years [46 to 86] Percentage male: 67.8% Ethnicity: NR
Interventions	Patients were randomised to outpatient, hospital‐based CR (Hosp‐CR), home‐based CR (Home‐CR), or no CR within 3 predefined age groups. Intervention: Hospital‐CR: programme 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. Components: Setting: centre or home. Aerobic exercise: Modality: cycle ergometer. Length of session: 35 min edurance training; 1 hour stretching and flexibility exercises. Frequency: 3 per week of endurance training; 2 per week of stretching and flexibility exercises. Intensity: 70% to 85% of heart rate. Resistance training included? No. Total duration: 8 weeks. Co‐interventions: Patients received cardiovascular risk factor management counselling twice per week and were invited to join a monthly support group together with family members. Comparator: Patients randomised to no CR were referred back to their family physicians. Co‐interventions: Patients received a single structured education session on cardiovascular risk factor management.
Outcomes	HRQL at month 2, 8 and 14. Costs over study duration.
Source of funding	National Research Council (CNR), the University of Florence, and the Regional Government of Tuscany, Italy.
Conflicts of interest	NR
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 of outcome assessment (detection bias) All outcomes	Low risk	"Testing personnel were blinded to patient assignment."
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)	Low risk	Changes in all outcomes reported for all time points (although absolute values not given).
Groups balanced at baseline	Low risk	In the entire series and within each age stratum, baseline sociodemographic and clinical characteristics were similar across the 3 arms of the trial (analysis not shown).
Intention‐to‐treat analysis conducted	High risk	No…but…. “we performed a sensitivity analysis comparing results obtained with and without replacement of missing data with data obtained with the expectation‐maximization imputation method. Because the 2 analyses provided similar results, which were also similar with missing data substituted with data estimated in a worst‐case scenario, only the data from patients who completed the study are presented"
Groups received same treatment (apart from the intervention)	Low risk	“Within each age group, participants were randomized to Hosp‐CR, Home‐CR, or no CR.” ”Patients in Hosp‐CR group received cardiovascular risk factor management counseling twice per week and were invited to join a monthly support group together with family members.” “Patients randomized to Home‐CR participated in 4 to 8 supervised instruction sessions in the CR unit, where they were taught necessary precautions and how to perform their training at home. Patients received cardiovascular risk factor management counseling at each in‐hospital session and were invited to join a monthly family oriented support group….and an exercise prescription similar to that of the Hosp‐CR group” Patients randomized to no CR attended a single structured education session on cardiovascular risk factor management with no exercise prescription and were referred back to their family physicians.