Home-based Exercise Therapy in Patients With Moderate to Severe Peripheral Artery Disease (NCT07655206)
Effectiveness of a Home-based Cardiovascular Rehabilitation Program Compared With Standard Care in Patients With Moderate to Severe Peripheral Artery Disease: a Pilot Randomized Controlled Trial (PILOT-PAD-CYCLE)
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Hôtel-Dieu de Lévis, CISSS de Chaudière-Appalaches — Lévis, Quebec
Age range: 18 Years
🧪 Interventions in This Study
- Home-Based Exercise Therapy Using Portable Pedal Exerciser (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Hôtel-Dieu de Lévis, CISSS de Chaudière-Appalaches — Lévis, Quebec
📞 Contact the Study Coordinator
Phone: (418) 835-7121
Email: jerome.patry.1@ulaval.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Peripheral Artery Disease
- Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2 — San Francisco, California
- Far Red Light to Improve Functioning in PAD — Birmingham, Alabama
- Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease — Chicago, Illinois
- Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD — Durham, North Carolina
- BEETroot Juice to Reverse Functional Impairment in PAD — Chicago, Illinois
- Exercise Therapy for PAD Using Mobile Health — Decatur, Georgia
Explore by condition: All Peripheral Artery Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.