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Structured home-based exercise versus invasive treatment: a mission impossible? A pilot randomized study in elderly patients with intermittent claudication |
Lamberti N, Malagoni AM, Ficarra V, Basaglia N, Manfredini R, Zamboni P, Mascoli F, Manfredini F |
Angiology 2016 Sep;67(8):772-780 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; 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* |
We compared the effects of an original structured home-based exercise program and revascularization in elderly patients with peripheral arterial disease over a 4-month period. Twenty-seven participants (n = 21; age 68 +/- 7 years) with moderate to severe claudication were randomized into (1) a test in-train out group (Ti-To; n = 18) that performed a home-based walking program prescribed and controlled at the hospital or (2) a revascularization group (Rev; n = 9) that underwent an endovascular and/or surgical procedure. The primary end point was quality of life as evaluated by the physical component summary (PCS) score of the Medical Outcomes Study Short Form 36 questionnaire. Secondary outcome measures included initial claudication distance (ICD) and absolute claudication distance (ACD), 6-minute walk distance (6MWD) and pain-free walk distance (PFWD), ankle-brachial index (ABI), and cost per walking meter gained. The PCS score significantly increased for both treatments at follow-up without a significant intergroup difference, as did ICD, ACD, and PFWD. The 6MWD and ABI significantly improved in the Rev group, and the Ti-To group exhibited a markedly lower cost per meter gained. The comparable effects of the 2 treatments need to be confirmed in a larger, randomized controlled trial.
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