Home-based Pedal Exerise Therapy for Moderate-to-Severe PAD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center, randomized pilot trial compares a home-based exercise program using a portable pedal exerciser plus standard care versus standard care alone in adults with moderate-to-severe PAD, including CLTI. Twelve participants are randomized 1:1 to assess feasibility, acceptability, and preliminary efficacy over 12 weeks. The intervention features an individualized exercise plan, remote supervision by a kinesiologist, cardiovascular education, and ongoing follow-up. Eligibility requires adult PAD with objective severity measures and inability or refusal to participate in in-person supervised therapy. Outcomes focus on feasibility metrics and early signals of functional improvement.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôtel-Dieu de Lévis, CISSS de Chaudière-Appalaches
  Lévis, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Jérôme Patry, DPM, MD, MSc
• Email: jerome.patry.1@ulaval.ca
• Phone: 418-835-7121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.