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. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3

Roman 1983.

Methods Study design: Single centre RCT
Country: Chile
Dates patients recruited: June 1973 to June 1981
Maximum follow up: 9 years
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
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.
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.