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

Recruiting now · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

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.

Key facts

Study ID

NCT07655206

Run by

Laval University

People needed

12

Starts

2026-06-23

Expected to finish

2027-05-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hôtel-Dieu de Lévis, CISSS de Chaudière-Appalaches — Lévis, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.