Home-based Exercise Therapy in Patients With Moderate to Severe Peripheral Artery Disease (PILOT-PADCYCLE)

June 15, 2026 updated by: Jérôme Patry, Laval University

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Peripheral arterial disease (PAD) is a major manifestation of systemic atherosclerosis and is associated with impaired walking capacity, functional decline, cardiovascular morbidity, reduced quality of life, and increased risk of lower limb amputation. Patients with moderate-to-severe PAD and chronic limb-threatening ischemia (CLTI) represent a particularly vulnerable population with substantial mobility limitations and high rates of cardiovascular events and mortality.

Supervised exercise therapy (SET) is recommended as a first-line therapy for symptomatic PAD and has demonstrated significant benefits on walking performance, functional capacity, and quality of life. However, access to SET programs remains limited in many regions due to geographic barriers, transportation difficulties, costs, limited specialized infrastructure, and poor adherence, particularly among individuals with advanced PAD, foot wounds, frailty, or mobility impairment.

Home-based exercise therapy (HET) has emerged as a promising alternative to traditional SET. Portable pedal exercisers may provide a low-cost, accessible, and feasible exercise modality for patients unable to participate in treadmill-based rehabilitation programs. However, evidence regarding the feasibility, acceptability, and preliminary efficacy of pedal exerciser-based HET in patients with moderate-to-severe PAD or CLTI remains limited.

The PILOT-PAD-CYCLE study is a prospective, single-center, pilot randomized controlled trial conducted at Hôtel-Dieu de Lévis (Québec, Canada). The study aims to evaluate the feasibility and acceptability of a 12-week HET program using a portable pedal exerciser in adults with moderate-to-severe PAD, including patients with foot wounds.

Twelve participants will be randomized in a 1:1 ratio to either:

  1. HET combined with standard vascular care; or
  2. Standard vascular care alone.

The intervention group will receive an individualized home-based exercise prescription supervised remotely by a kinesiologist. Participants will be encouraged to perform structured exercise sessions using a portable pedal exerciser over a 12-week period. The intervention also includes cardiovascular risk factor education, exercise progression monitoring, and regular follow-up contacts to support adherence and safety.

Feasibility outcomes include recruitment rate, retention rate, intervention adherence, completion of study assessments, and adverse events. Acceptability will be evaluated through participant satisfaction and perceived usability of the intervention.

Preliminary efficacy outcomes include changes in walking capacity measured by the 6-minute walk test, vascular perfusion parameters, patient-reported quality of life, pain, wound-related outcomes when applicable, and cardiovascular or limb-related events during follow-up up to 6 months.

This pilot trial is intended to provide essential feasibility data, estimate variability of clinical outcomes, and inform the design and sample size calculation of a future multicenter randomized controlled trial evaluating home-based pedal exerciser rehabilitation in patients with moderate-to-severe PAD and foot wounds.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • Hôtel-Dieu de Lévis, CISSS de Chaudière-Appalaches
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based exercise therapy (HET) plus standard care
Standard care
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.
No Intervention: Standard Care
Usual standard care delivered by their physician for peripheral artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the HET Program
Time Frame: Baseline and 13 weeks
Assessment of recruitment rate, adherence to prescribed exercise sessions, intervention completion (in %)
Baseline and 13 weeks
Acceptability of the HET program : questionnaire
Time Frame: 13 weeks
Participants acceptability questionnaire score (numeric score from 4 to 20; 4 representing the lowest acceptability score and 20 representing the highest acceptability score)
13 weeks
Acceptability of HET program : qualitative interview findings
Time Frame: Between 13 weeks and 25 weeks
Participants acceptability based on a semi-structured interview (no units of measure)
Between 13 weeks and 25 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6-Minute Walk Test Distance
Time Frame: Baseline and 13 weeks
Difference in walking distance measured during the 6-minute walk test between baseline and week 13. (in meters)
Baseline and 13 weeks
Change in peripheral vascular perfusion : ankle-brachial index (ABI)
Time Frame: Baseline and 13 weeks
Difference in ankle-brachial index (ABI) between baseline and week 13 (no units of measure)
Baseline and 13 weeks
Change in peripheral vascular perfusion : toe-brachial index (TBI)
Time Frame: Baseline and 13 weeks
Difference in toe-brachial index values between baseline and week 13 (no units of measure)
Baseline and 13 weeks
Change in peripheral vascular perfusion : toe systolic pressure measurements
Time Frame: Baseline and 13 weeks
Difference in toe systolic pressure measurements between baseline and week 13 (mmHg)
Baseline and 13 weeks
Change in Quality of Life
Time Frame: Baseline and 13 weeks
Changes in quality of life measured using the SF-36 questionnaire.
Baseline and 13 weeks
Major Cardiovascular Events
Time Frame: Up to 6 months after completion of the intervention
Occurrence of any major cardiovascular events (including revascularization, amputation, myocardial infarction, stroke, chronic limb-threatening ischemia progression, and death)
Up to 6 months after completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

CISSS de Chaudière-Appalaches
VITAM - Centre de recherche en santé durable

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CISSSCA-2026-1325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in publications may be made available upon reasonable request to the principal investigator, following publication of the primary results, and subject to approval by the research ethics board and execution of a data-sharing agreement.

IPD Sharing Time Frame

Beginning 6 months following publication and ending 5 years after publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal for purposes consistent with the approved study objectives.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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