Methods | Cluster randomised multi-centre study (hospitals in and around Newcatle, Australia); F/U of 6 months | |
Participants | N=450 (EX n=213; CON n=237) 71% male Mean age: EX = 59 +/− 8, CON = 58 +/− 8 years Diagnosis: Ethnicity: NR Inclusion: <70 years with a suspected heart attack registered by the Newcastle collaborating centre of the WHO MONICA Project and discharged alive from hospital Exclusion: renal failure or other special dietary requirements and those considered by their physicians to have ‘endstage’ heart disease |
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Interventions | Exercise group: 3 packages to participant - 1st package: Step 1“Facts on fat” kit, together with walking programmme information (also (encouragement to walk in the form of a magnetic reminder sticker), and “Quit for Life” program for smokers. 2nd package: Step 2-3 “Facts on fat” kit; exercise log. 3rd package: Step 4-5 “Facts on fat” kit, together with information regarding local “Walking for Pleasure” groups Control group: usual care |
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Outcomes | Total mortality, health-related quality of life: QLMI Study outcomes assessed at 6 months |
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Notes | Low use of preventative services (dietary, anti smoking) by both groups. 10% of patients received rehab - mostly having had CABG. |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Cluster randomisation by GP. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear in terms of assessment of outcomes. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 17% lost to follow up, no description of withdrawals or dropouts |
Selective reporting (reporting bias) | Unclear risk | No information reported. |