Abstract
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].
Highlights
Peripheral artery disease (PAD) of the lower limbs is an underestimated pathology that is highly prevalent in elderly individuals [1]
Exercise therapy is recommended as the initial treatment for its effectiveness on the walking disability, with lower morbidity, mortality and healthcare costs compared to endovascular or surgical revascularization [1]
structured home-based exercise (SHB) is even less effective than supervised exercise therapy (SET) but is still recommended with a Class IIa
Summary
Peripheral artery disease (PAD) of the lower limbs is an underestimated pathology that is highly prevalent in elderly individuals [1]. PAD, which, in a percentage of cases, may evolve to critical limb ischemia requiring revascularization and amputation, is primarily associated with a high risk of cardiovascular events [1]. Management of PAD may reduce patients’ disability and functional decline as well amputations and cardiovascular events. Exercise therapy is recommended as the initial treatment for its effectiveness on the walking disability, with lower morbidity, mortality and healthcare costs compared to endovascular or surgical revascularization [1]. Supervised exercise therapy (SET) programs performed at hospitals are recommended [1,2], as they can significantly improve exercise capacity in patients both with and without claudication and are more effective than unsupervised programs [1,3,4,5,6]. SET has shown a poor impact on patients’ lifestyles in terms of low long-term adherence rates and high variability in rehabilitative outcomes [5,6,9,11] with a high nonresponse rate (37.5%) [12] and lower benefits paradoxically observed in patients with more severe disability [5]
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