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

Belardinelli 2001.

Methods Study design: Single centre RCT
Country: Italy
Dates patients recruited: NR
Maximum follow up: 33 (SD 7) months
Participants Inclusion criteria: Successful procedure of coronary angioplasty in 1 or 2 native epicardial coronary arteries and ability to exercise.
Exclusion criteria: Previous coronary artery procedures, cardiogenic shock, unsuccessful angioplasty (defined as residual stenosis > 30% of initial value), complex ventricular arrhythmias, uncontrolled hypertension and diabetes mellitus, creatinine > 2.5 mg/dl, orthopedic or neurological limitations to exercise or unstable angina after procedure and before enrolment.
N Randomised: total:118; intervention: 59; comparator: 59
Diagnosis (% of pts):
Myocardial Infarction: intervention: 51; comparator: 47
Hypercholesterolemia: intervention: 61; comparator: 54
Diabetes: intervention: 17; comparator: 20
Hypertension: intervention: 42; comparator: 47
LVEF (%): intervention: 52 (SD 16); comparator: 50 (SD 14)
Age (mean ± SD): intervention: 53 ± 11 ; comparator: 59 ± 10
Percentage male: intervention: 83.1%; comparator: 84.8%
 Percentage white: NR
Interventions Intervention: Exercise sessions were performed at the hospital gym and were supervised by a cardiologist. After a 15‐min phase of stretching and calisthenics, patients pedalled on an electronically braked cycle ergometer at the target work rate for 30 min. This working phase was preceded by a 5‐min loadless warm‐up and followed by 3 min of unloaded cool‐down pedaling.
Components: exercise only.
Setting: supervised in hospital gym.
Aerobic exercise:
Modality: electronically braked cycle ergometer.
Length of session: 53 min.
Frequency: 3 sessions/week.
Intensity: 60% of peak oxygen uptake (VO2).
Resistance training included? Yes ‐ calisthenics.
Total duration: six months.
Co‐interventions: none described.
Comparator: Control patients were recommended to perform basic daily mild physical activities but to avoid any physical training. A list of acceptable physical activities was provided, together with a diary to report daily activities.
Co‐interventions: none described.
Outcomes Cardiac mortality; myocardial infarction; coronary angioplasty (percutaneous transluminal coronary angioplasty, coronary stent); coronary artery bypass graft; health‐related quality of life: MOS Short‐Form General Health Survey.
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 Not reported.
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 High risk Cardiac events of 12 patients who were excluded not accounted for.
Selective reporting (reporting bias) Low risk All outcomes were reported at all time points.
Groups balanced at baseline Low risk Groups were well balanced for pathophysiological and clinical variables.
Intention‐to‐treat analysis conducted Low risk Yes.
Groups received same treatment (apart from the intervention) Low risk Both the exercise and the control groups were subjected to the same
scrutiny and management regimen, apart from the exercise component.