Methods | RCT, single centre in Italy 33 (SD 7) months |
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Participants |
N Randomised: Total:118 (99 males, 19 females); EX: 59 (49 males, 10 females) UC: 59 (50 males, 9 females) Diagnosis (% of pts); Myocardial Infarction: EX 51; UC 47 Hypercholesterolemia: EX 61; UC 54 Diabetes: EX 17; UC 20 Hypertension: EX 42; UC 47 LVEF (%): EX 52 (SD 16); UC 50 (SD 14) Case mix: Age (years): EX: 53 (SD 11); UC: 59 (SD 10) Percentage male: EX 83.1%; UC 84.8% Percentage white: Not reported Inclusion/exclusion criteria: Inclusion: successful procedure of coronary angioplasty in 1 or 2 native epicardial coronary arteries and ability to exercise Exclusion: 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 |
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Interventions |
Exercise:
Total duration: six months aerobic/resistance/mix: exercise sessions were performedat the hospital gym and were supervised by a cardiologist frequency: 3 sessions/week duration: 15 min of stretching and callisthenics; 5 min of loadless warm-up; 30 min of pedaling on electronically braked cycle ergometer at target work rate; 3 min of unloaded cool-down pedaling intensity: 60% of peak oxygen uptake (VO2) modality: electronically braked cycle ergometer Usual care: “Control patients were recommended to perform basic daily mild physical activities but to avoid any physical training.” |
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Outcomes | Cardiac mortality; myocardial infarction; coronary angioplasty (percutaneous translu-minal coronary angioplasty, coronary stent); coronary artery bypass graft; health-related quality of life: MOS Short-Form General Health Survey | |
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 (performance bias and detection bias) All outcomes |
Unclear risk | “All studies were performed by
experienced operators and evaluated
by two independent observers blinded
to treatment arm and to each otherls interpretation. ” Comment: This only applied to exercise test & angiography only so assessment of events and health-related quality of life (although patient self complete) not necessarily blinded |
Incomplete outcome data (attrition bias) All outcomes |
High risk | Cardiac events of 12 patients who were excluded not accounted for |
Selective reporting (reporting bias) | Unclear risk | No information reported. |