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The Extensive Lifestyle Management Intervention (ELMI) following cardiac rehabilitation trial
Lear SA, Ignaszewski A, Linden W, Brozic A, Kiess M, Spinelli JJ, Pritchard PH, Frohlich JJ
European Heart Journal 2003 Nov;24(21):1920-1927
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIM: Previous studies have reported lifestyle and risk factor deterioration following completion of a cardiac rehabilitation program (CRP). We report the results of a one-year extensive lifestyle management intervention (ELMI) aimed at preventing these adverse changes. METHODS AND RESULTS: A total of 302 men and women with ischaemic heart disease were recruited following completion of a CRP and randomized to either the ELMI (consisting of exercise sessions, telephone follow-ups and risk factor and lifestyle counselling) or usual care. The primary outcome was global cardiovascular risk using the Framingham and Procam risk scores. Secondary outcomes included risk factors and lifestyle behaviours. Baseline characteristics were similar between the two groups. Adherence to the ELMI was high. There was a non-significant trend in favour of the ELMI between for both the Framingham (6.6 +/- 3.1 to 6.2 +/- 2.9 versus 6.6 +/- 3.2 to 6.7 +/- 3.2, p = 0.138) and Procam (20.0 +/- 20.0 to 20.6 +/- 19.5 versus 19.1 +/- 18.7 to 21.8 +/- 19.1, p = 0.089) scores. There were no differences in secondary outcomes. CONCLUSIONS: A one-year multi-factorial post-CRP intervention results in modest, non-significant benefits to global risk compared to usual care. The absence of deterioration in the usual care group may be due to improved practices in usual care.
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