RecruitingNot Applicable

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

Canada12 participantsStarted 2026-06-23

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of the HET Program

Timeframe: Baseline and 13 weeks

Acceptability of the HET program : questionnaire

Timeframe: 13 weeks

Acceptability of HET program : qualitative interview findings

Timeframe: Between 13 weeks and 25 weeks

Trial details

NCT IDNCT07655206

SponsorLaval University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Jérôme Patry, DPM, MD, MSc

418-835-7121 jerome.patry.1@ulaval.ca

View on ClinicalTrials.gov More Peripheral Artery Disease trials