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. Author manuscript; available in PMC: 2014 Nov 13.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2
Methods RCT, single centre in Italy
33 (SD 7) months
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
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.”
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.