Home-based Exercise Therapy in Patients With Moderate to Severe Peripheral Artery Disease (PILOT-PADCYCLE)

Peripheral arterial disease (PAD) is a major manifestation of systemic atherosclerosis and is associated with impaired walking capacity, functional decline, cardiovascular morbidity, reduced quality of life, and increased risk of lower limb amputation. Patients with moderate-to-severe PAD and chronic limb-threatening ischemia (CLTI) represent a particularly vulnerable population with substantial mobility limitations and high rates of cardiovascular events and mortality.

Supervised exercise therapy (SET) is recommended as a first-line therapy for symptomatic PAD and has demonstrated significant benefits on walking performance, functional capacity, and quality of life. However, access to SET programs remains limited in many regions due to geographic barriers, transportation difficulties, costs, limited specialized infrastructure, and poor adherence, particularly among individuals with advanced PAD, foot wounds, frailty, or mobility impairment.

Home-based exercise therapy (HET) has emerged as a promising alternative to traditional SET. Portable pedal exercisers may provide a low-cost, accessible, and feasible exercise modality for patients unable to participate in treadmill-based rehabilitation programs. However, evidence regarding the feasibility, acceptability, and preliminary efficacy of pedal exerciser-based HET in patients with moderate-to-severe PAD or CLTI remains limited.

The PILOT-PAD-CYCLE study is a prospective, single-center, pilot randomized controlled trial conducted at Hôtel-Dieu de Lévis (Québec, Canada). The study aims to evaluate the feasibility and acceptability of a 12-week HET program using a portable pedal exerciser in adults with moderate-to-severe PAD, including patients with foot wounds.

Twelve participants will be randomized in a 1:1 ratio to either:

1. HET combined with standard vascular care; or
2. Standard vascular care alone.

The intervention group will receive an individualized home-based exercise prescription supervised remotely by a kinesiologist. Participants will be encouraged to perform structured exercise sessions using a portable pedal exerciser over a 12-week period. The intervention also includes cardiovascular risk factor education, exercise progression monitoring, and regular follow-up contacts to support adherence and safety.

Feasibility outcomes include recruitment rate, retention rate, intervention adherence, completion of study assessments, and adverse events. Acceptability will be evaluated through participant satisfaction and perceived usability of the intervention.

Preliminary efficacy outcomes include changes in walking capacity measured by the 6-minute walk test, vascular perfusion parameters, patient-reported quality of life, pain, wound-related outcomes when applicable, and cardiovascular or limb-related events during follow-up up to 6 months.

This pilot trial is intended to provide essential feasibility data, estimate variability of clinical outcomes, and inform the design and sample size calculation of a future multicenter randomized controlled trial evaluating home-based pedal exerciser rehabilitation in patients with moderate-to-severe PAD and foot wounds.