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

NCT07655206 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-06-26

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Home-Based Exercise Therapy Using Portable Pedal Exerciser

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.

Sponsors & Collaborators

  • VITAM - Centre de recherche en santé durable

    collaborator UNKNOWN

  • CISSS de Chaudière-Appalaches

    collaborator OTHER_GOV

  • Laval University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-23
Primary Completion
2026-12-01
Completion
2027-05-01

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07655206 on ClinicalTrials.gov