Specchia 1996.
Study characteristics | ||
Methods |
Study design: single‐centre RCT Country: Italy Dates participants recruited: NR (40‐month period) Maximum follow‐up: mean 34.5 months |
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Participants |
Inclusion criteria: participants < 65 years of age who had not had previous MI, admitted due to chest pain lasting > 30 minutes and because they had a diagnosis of AMI based on evolutionary ECG changes and serum kinase elevation. Exclusion criteria: complicated in‐hospital clinical course e.g. post‐infarction angina requiring urgent revascularisation; evidence of congestive HF; chronic concomitant illnesses or musculoskeletal handicaps that would prevent them from finishing the exercise training period. N randomised: total: 256; intervention: 125; comparator: 131 Diagnosis (% of participants): MI: 100% Prior angina: 42% Age (Mean ± SD): intervention: 51.5 ± 7; comparator: 54.3 ± 8 Percentage male: 91% intervention: 91%; comparator: 91% Ethnicity: NR |
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Interventions |
Intervention: participants underwent a 4‐week physical training period consisting of supervised training sessions of 30 minutes of bicycle ergometry five times a week combined with callisthenics. Training intensity was graded according to 75% of maximal work capacity reached in the previous exercise test. At the end of the 4‐week training period, a second symptom‐limited exercise test was performed. Participants were then discharged with the instructions to continue the callisthenics daily and to walk for ≥ 30 minutes every 2 days. Components: exercise, education and psychology. Setting: centre and then home. Exercise programme modality: bicycle ergometry in centre followed by callisthenics and walking at home. Length of session: ≥ 30 minutes. Frequency: five times a week in centre followed by daily callisthenics and walking every other day. Intensity: 75% of maximal work capacity. Resistance training included? Callisthenics. Total duration: 4 weeks supervised and then continued at home. Co‐interventions: All participants went to the Rehabilitation Center for 3 weeks and underwent a symptom‐limited exercise test (28 ± 2 days after myocardial infarction), 24‐hour Holter monitoring, and coronary arteriography (31 ± 3 days after the acute episode). All participants attended colloquial sessions, held by a cardiologist and a psychologist, dealing with secondary prevention of cardiovascular diseases and stressing dietary changes and smoking cessation. Comparator: Discharged after rehab centre and clinically re‐examined 1 month later when they underwent a second symptom‐limited exercise test. Co‐interventions: as above |
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Outcomes | CHD mortality, revascularisations | |
Source of funding | NR | |
Conflicts of interest | NR | |
Notes | Ejection fraction (EF) was the only prognostic factor. Among 51 participants with EF < 41%, relative risk for the 27 untrained participants was 8.63 times higher than for 24 trained ones. (P = 0.04) If EF > 40%, estimated risk for untrained participant was 1.07 times higher than for trained. | |
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 | No losses to follow‐up. |
Selective reporting (reporting bias) | High risk | While survival data is provided, detailed clinical information was obtained from all participants at 3‐ to 4‐month intervals and these data are not reported. |