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

Sponsor
Laval University
Study ID
NCT07655206
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Home-Based Exercise Therapy Using Portable Pedal Exerciser — BEHAVIORAL
    Participants randomized to the intervention arm will receive a 12-week individualized home-based cardiovascular rehabilitation program using a portable pedal exerciser. The intervention includes: Initial 60-minute educational session Aerobic exercise prescription (3-5 sessions/week; 10-30 minutes/session) Moderate exercise intensity (Borg 3-5/10) Resistance exercises 2-3 times/week Telephone or videoconference follow-up twice weekly Cardiovascular risk factor counseling and educational support Walking exercise may also be prescribed when clinically appropriate.

Study Details

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 Dates

First listed
Jun 17, 2026
Start date
Jun 23, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Home-based exercise therapy (HET) plus standard care
    Standard care
  • No Intervention: Standard Care
    Usual standard care delivered by their physician for peripheral artery disease

Primary Outcome Measure

Feasibility of the HET Program [ Time Frame: Baseline and 13 weeks ]

Central Contacts

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