La Rovere 2002.
| Study characteristics | ||
| Methods |
Study design: single‐centre RCT Country: Italy Dates participants recruited: 1984 to 1985 Maximum follow‐up: 10 years |
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| Participants |
Inclusion criteria: post‐MI patients admitted at Centro Medico di Montescano in 1984 to 1985 Exclusion criteria: atrial fibrillation or abnormal sinus node function, insulin‐dependent diabetes, exercise‐induced myocardial ischaemia, and arterial BP > 160/90 N randomised: total: 95; intervention: 49; comparator: 46 Diagnosis (% of participants): uncomplicated MI: 100% Age (mean): intervention: 51; comparator: 52 Percentage male: 100% Ethnicity: NR |
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| Interventions |
Intervention: the exercise sessions (30 minutes, 5 times a week) consisted of callisthenics and stationary bicycle ergometry Components: exercise, education and psychological Setting: supervised in a centre Exercise programme modality: stationary bicycle ergometry Length of session: 30 minutes Frequency: 5 times a week Intensity: 75% of heart rate at peak V02, rising to 85% in the second and third weeks and 95% in the final week Resistance training included? Yes ‐ callisthenics Total duration: 4 weeks Co‐interventions: sessions were held by cardiologists and psychologists, dealing with secondary prevention of cardiovascular disease and stressing dietary changes and smoking cessation. Comparator: no training Co‐interventions: all participants attended sessions, held by a cardiologist and a psychologist, dealing with secondary prevention of cardiovascular disease and stressing dietary changes and smoking cessation. |
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| Outcomes | Cardiac mortality; non‐fatal MI; CABG at 3 to 4 month intervals from the time of entry into the study for the first 3 years and contacted periodically by telephone thereafter. | |
| Source of funding | NR | |
| Conflicts of interest | NR | |
| 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 of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for |
| Selective reporting (reporting bias) | High risk | Results not reported for all time points collected |