Belardinelli 2001.
Methods |
Study design: Single centre RCT Country: Italy Dates patients recruited: NR Maximum follow up: 33 (SD 7) months |
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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 |
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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. |
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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. |