Manfredini Fabio, Lamberti Nicola, Traina Luca, Zenunaj Gladiol, Medini Chiara, Piva Giovanni, Straudi Sofia, Manfredini Roberto, Gasbarro Vincenzo
Department of Neuroscience and Rehabilitation, University of Ferrara, 44121 Ferrara, Italy.
Unit of Rehabilitation Medicine, University Hospital of Ferrara, 44124 Ferrara, Italy.
Methods Protoc. 2021 May 10;4(2):29. doi: 10.3390/mps4020029.
Exercise therapy in the intermediate stages of peripheral artery disease (PAD) represents an effective solution to improve mobility and quality of life (QoL). Home-based programs, although less effective than supervised programs, have been found to be successful when conducted at high intensity by walking near maximal pain. In this randomized trial, we aim to compare a low-intensity, pain-free structured home-based exercise (SHB) program to an active control group that will be advised to walk according to guidelines. Sixty PAD patients aged > 60 years with claudication will be randomized with a 1:1 ratio to SHB or Control. Patients in the training group will be prescribed an interval walking program at controlled speed to be performed at home; the speed will be increased weekly. At baseline and after 6 months, the following outcomes will be collected: pain-free walking distance and 6-min walking distance (primary outcome), ankle-brachial index, QoL by the VascuQoL-6 questionnaire, foot temperature by thermal camera, 5-time sit-to-stand test, and long-term clinical outcomes including revascularization rate and mortality. The home-based pain-free exercise program may represent a sustainable and cost effective option for patients and health services. The trial has been approved by the CE-AVEC Ethics Committee (898/20). Registration details: Clinicaltrials.gov NCT04751890 [Registered: 12 February 2021].
外周动脉疾病（PAD）中期的运动疗法是改善活动能力和生活质量（QoL）的有效解决方案。家庭锻炼计划虽然不如有监督的计划有效，但已发现当以接近最大疼痛程度的高强度行走来进行时是成功的。在这项随机试验中，我们旨在比较低强度、无痛的结构化家庭锻炼（SHB）计划与将被建议按照指南行走的积极对照组。60名年龄大于60岁且有间歇性跛行的PAD患者将以1:1的比例随机分为SHB组或对照组。训练组的患者将被规定以可控速度进行的间歇步行计划，在家中进行；速度将每周增加。在基线和6个月后，将收集以下结果：无痛步行距离和6分钟步行距离（主要结果）、踝臂指数、通过VascuQoL-6问卷评估的生活质量、通过热成像仪测量的足部温度、5次坐立试验以及包括血运重建率和死亡率在内的长期临床结果。基于家庭的无痛锻炼计划可能是患者和医疗服务的一种可持续且具有成本效益的选择。该试验已获得CE-AVEC伦理委员会批准（898/20）。注册详情：Clinicaltrials.gov NCT04751890 [注册日期：2021年2月12日]
