Methods | Parallel RCT; single centre in Alton, Hampshire | |
Participants | N: 200 (EX n=99; CON n101=) Gender: 100% men Age: EX = 54.2 (+/−7.2), CON = 53.2 (+/−7.7). Diagnosis: 5 days post MI. Ethnicity:NR Inclusion: <65 yrs post MI; history of chest pain typical of MI, progressive ECG changes, rise and fall in aspartate transaminase concentrations with at least one reading above 40 units/ml Exclusion: medical or orthopaedic problems that precluded their taking part in the exercise course; insulin dependent diabetes mellitus; atrial fibrillation; on investigator’s personal general practice list |
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Interventions | Exercise group: Duration: 3 months; Frequency: 3×/week; Mode: 8 stage circuit aerobic & weight training. Intensity: 70-85% predicted HRmax Control group: given a short talk on the sort of exercise that they might safely take unsupervised |
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Outcomes | Total mortality, CHD mortality, non fatal MI (11 year follow up published in 1999. 5 year follow up data from unpublished material used for meta analysis.) | |
Notes | 229 patients were randomised; 14 in the intervention group and 15 in control dropped out before the first exercise test due to death, refusal or other problems. Therefore 200 took part in the study Cardiac mortality of 3% pa, once patients survived to be in the trial. Suggests more severely affected patients were not included. Significant predictors of cardiac death were pulmonary oedema on admission, complications during admission, one or more previous infarcts, increasing age and low initial fitness |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | random letter sequence |
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 | 16% lost to follow up, no description of withdrawals or dropouts |
Selective reporting (reporting bias) | Unclear risk | No information reported. |