Roman 1983.
Methods |
Study design: Single centre RCT Country: Chile Dates patients recruited: June 1973 to June 1981 Maximum follow up: 9 years |
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Participants |
Inclusion criteria: Patients with transmural AMI. Exclusion criteria: Severe arrhythmias persisting after the acute phase of AMI (frequent ventricular premature beats, grade iii‐iv of the Lown classification, atrial flutter, partial or complete A_V block);great left‐ventricular enlargement; left ventricular aneurysm; persistent cardiac failure; severe diastolic hypertension post‐myocardial infarction angina. N Randomised: total: 193; intervention: 93; comparator: 100 Diagnosis (% of pts): Transmural AMI: 100% Anterior wall infarction: 55% Posteroinferior infarction: 45% Age (mean ± SD): intervention: 56.2 ± 10.3; comparator: 59.1 ± 8.8 Percentage male: intervention: 93.6%; comparator: 87% Ethnicity: NR |
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Interventions |
Intervention: Supervised physical training programme according to the guidelines reported by Zohman and Tobias. It was started with combined ergometric, calisthenic and walk‐jogging exercise lasting 30 min, three times a week. The intensity of the training was graded according to the target heart rate threshold, defined as 70% of maximal heart rate achieved by the patient in the former ergometric work test. Components: exercise only. Setting: centre. Aerobic exercise: Modality: combined ergometric and walk‐jogging exercise. Length of session: 30 min. Frequency: three times a week. Intensity: 70% of maximal heart rate. Resistance training included? Calisthenics. Total duration: average 42 months (range 6 to 108 months). Co‐interventions: none described. Comparator: Control patients were medically treated according to the guidelines commonly used, namely, short‐ and long‐lasting nitrites, ß‐ blockers or Ca antagonists (nifedipine). Co‐interventions: A small number (8 patients) were also treated with oral anticoagulants. |
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Outcomes | Mortality, MI and revascularisations. | |
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 | “Patients were randomly allocated…” |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 18/93 (19.4%) and 18/100 (18%) withdrew or dropped out from intervention and control groups over the 9‐year period. |
Selective reporting (reporting bias) | Low risk | Mortality, morbidity and complications were recorded over the duration of the study and are presented as rates. |
Groups balanced at baseline | Low risk | “as can be observed, both groups were matched in all the characteristics that could eventually alter the late prognosis of the disease” |
Intention‐to‐treat analysis conducted | Low risk | ITT not described, and no details of how missing data is handled are given, but groups appeared to be analysed according to original allocation. |
Groups received same treatment (apart from the intervention) | Unclear risk | Control patients were medically treated throughout, but it appears that CR patients were only prescribed medication on the appearance of unstable angina or electrocardiographic ischemia. |