Home-based Exercise Therapy in Patients With Moderate to Severe Peripheral Artery Disease

Peripheral arterial disease (PAD) is a chronic atherosclerotic condition associated with impaired mobility, reduced quality of life, cardiovascular events, and risk of lower limb amputation. Although supervised exercise therapy (SET) is recommended for symptomatic PAD, access and adherence remain limited, particularly among patients with moderate-to-severe disease or chronic limb-threatening ischemia (CLTI). The PILOT-PAD-CYCLE study is a prospective, single-center, pilot randomized controlled trial designed to evaluate the feasibility, acceptability, and preliminary efficacy of a 12-week home-based exercise therapy (HET) program using a portable pedal exerciser in adults with moderate-to-severe PAD, including CLTI, with or without foot wounds. Twelve participants will be randomized 1:1 to either HET plus standard care or standard care alone. The intervention includes individualized exercise prescription, remote supervision by a kinesiologist, cardiovascular education, and follow-up over 12 weeks. Outcomes include feasibility and acceptability metrics, 6-minute walk test distance, vascular perfusion indices, quality of life, and cardiovascular events up to 6 months. This pilot trial aims to generate feasibility data and preliminary efficacy estimates to support the development of a future multicenter randomized controlled trial.

Inclusion Criteria: * Adults aged 18 years or older * Moderate-to-severe peripheral arterial disease defined by at least one of the following: ABI \< 0.6 Ankle systolic pressure \< 70 mmHg Toe systolic pressure \< 40 mmHg Toe-brachial index \< 0.4 * With or without lower limb wound * Declined referral to an in-person supervised exercise therapy program * Able to provide informed consent Exclusion Criteria: * Lower limb revascularization within the previous 30 days * Planned revascularization during the first 12 weeks of the study * Unable to use a portable pedal exerciser * Unable to perform a 6-minute walk test * Medically unstable according to the treating clinical or rehabilitation team * Participation in a cardiovascular rehabilitation program within the previous year