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.

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.

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

De-identified individual participant data underlying the results reported in publications may be made available upon reasonable request to the principal investigator, following publication of the primary results, and subject to approval by the research ethics board and execution of a data-sharing agreement.

Beginning 6 months following publication and ending 5 years after publication.

Researchers who provide a methodologically sound proposal for purposes consistent with the approved study objectives.

Participants, clinical staff, and research personnel will be aware of group allocation. Statistical analyses will be conducted while preserving group blinding whenever feasible.