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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 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
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.
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
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.