Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in XXXX .

@entity1 @entity613 @entity865
BACKGROUND: To compare angioplasty ( @entity865 ), supervised exercise (SEP) and @entity865 + SEP in the treatment of @entity613 ( @entity613 ) due to femoropopliteal disease. METHODS: Over a 6-year period, 178 @entity1 (108 @entity1 ; median age, 70 years) with femoropopliteal lesions suitable for angioplasty were randomized to @entity865 , SEP, or @entity865 + SEP. @entity1 were assessed prior to and at 1 and 3 months post treatment. ISCVS outcome criteria (ankle pressures, treadmill walking distances) and quality of life (QoL) questionnaires (SF-36 and VascuQoL) were analyzed. RESULTS: All groups were well matched at baseline. Twenty-one @entity1 withdrew. Results are as follows: Intragroup analysis: All groups demonstrated significant clinical and QoL improvements (Friedman test, p < 0.05). SEP (60 @entity1 , 8 withdrew)-62.7% of @entity1 (n = 32) improved following treatment [20 mild, 9 moderate, 3 marked], 27.4% (n = 14) demonstrated no improvement, and 9.8% (n = 5) deteriorated. @entity865 (60 @entity1 , 3 withdrew)-66.6% @entity1 (n = 38) improved following treatment [19 mild, 10 moderate, 9 marked], 22.8% (n = 13) demonstrated no improvement, and 10.5% (n = 6) deteriorated. @entity865 + SEP (58 @entity1 , 10 withdrew)-81.6% of @entity1 (n = 40) improved following treatment [10 mild, 17 moderate, 3 marked], 14.2% (n = 7) demonstrated no improvement, and 4.0% (n = 2) deteriorated. Intergroup analysis: @entity865 + SEP produce a much greater improvement in clinical outcome measures than @entity865 or SEP alone, but there was no significant QoL advantage (Kruskal-Wallis test, p > 0.05). CONCLUSION: SEP should be the primary treatment for the @entity1 with @entity613 and @entity865 should be supplemented by an SEP.
