Methods | Prospective RCT in US (patients recruited from 2 sites) F/U 5 years | |
Participants | N= 48 (EX n=28; CON n=20) Gender: NR for all 48 patients Mean age: EX = 56.1 +/− 7.5; CON=59.8 +/− 9.1 years Diagnosis: moderate to severe CAD (MI, PTCA, CABG, angina) Ethnicity: NR Inclusion: 35-75 years, male or female; residence in the greater San Francisco area; no other life-threatening illnesses; no MI during the preceding 6 weeks, no history of receiving streptokinase or alteplase; not currently receiving lipid-lowering drugs; 1, 2, 3 vessel coronary artery disease (defined as any measurable coronary atherosclerosis in a non-dilated or non-bypass grafting; permission granted by patient’s cardiologist and primary care physician |
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Interventions | Exercise intervention: exercise (typically walking) for a minimum of 3 hours per week and 30 min per session; target training heart rate of 50-80%. Co-interventions: stress management, low fat vegetarian diet, group psychosocial support . 1 year duration Control group: usual care. |
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Outcomes | CHD mortality, non-fatal MI, revascularisation, Assessment at baseline and after 1 year and 5 year | |
Notes | I had 91% reduction in reported frequency of angina after 1 year and 72% after 5, C had 186% increase in reported frequency of angina after 1 year and 36% decrease after 5. I had 7.9% relative improvement in coronary artery diameter at 5 years, C had 27.7% relative worsening at 5 years |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “randomly assigned” |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) All outcomes |
Low risk | “…investigators carrying out all medical tests remained unaware of both patient group assignment and the order ofthe tests. Different people provided the lifestyle intervention, carried out the tests, analysed the results, and carried out statistical analyses. Coronary arteriograms were analysed without knowledge ofsequence or ofgroup assignment.” |
Incomplete outcome data (attrition bias) All outcomes |
High risk | 45/93 (48%) of randomised patients did not participate, no description of withdrawals or dropouts |
Selective reporting (reporting bias) | Unclear risk | No information reported. |