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Effectiveness of a new exercise program after lower limb arterial blood flow surgery in patients with peripheral arterial disease: a randomized clinical trial |
Jakubseviciene E, Vasiliauskas D, Velicka L, Kubilius R, Milinaviciene E, Vencloviene J |
International Journal of Environmental Research & Public Health 2014 Aug;11(8):7961-7976 |
clinical trial |
5/10 [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: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: The aim of this study was to evaluate the effectiveness of a supervised exercise program (SEP) plus at home nonsupervised exercise therapy (non-SET) on functional status, quality of life (QoL) and hemodynamic response in post-lower-limb bypass surgery patients. RESULTS: One hundred and seventeen patients were randomized to an intervention (n = 57) or a control group (n = 60). A new individual SEP was designed for patients with peripheral arterial disease (PAD) and applied to the studied subjects of the intervention group who also continued non-SET at home, whereas those assigned to the control group received just usual SEP according to a common cardiovascular program. The participants of the study were assessed by a 6-min walking test (6 MWT), an ankle-brachial index (ABI), and the Medical Outcomes Study Short Form-36 (SF-36) of QoL at baseline, at 1 and 6 months after surgery. A significant improvement was observed in the walked distance in the intervention group after 6 months compared with the control group (p < 0.001). The intervention group had significantly higher QoL score in the physical and mental component of SF-36 (p < 0.05). CONCLUSIONS: A 6-month application of the new SEP and non-SET at home has yielded significantly better results in walking distance and QoL in the intervention group than in the controls.
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