Recruiting

Home-based Exercise Therapy

Sponsor:

Laval University

Code:

NCT07655206

Conditions

Peripheral Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home-Based Exercise Therapy Using Portable Pedal Exerciser

Study Details

Brief 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

Peripheral Artery Disease

Study ID

NCT07655206

Start date

Jun 23, 2026

Status verified date

Jun, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

  • Feasibility of the HET Program [ Time Frame: Baseline and 13 weeks ]
  • Acceptability of the HET program : questionnaire [ Time Frame: 13 weeks ]
  • Acceptability of HET program : qualitative interview findings [ Time Frame: Between 13 weeks and 25 weeks ]

Central Contacts and Locations

Central contacts

Jérôme Patry, DPM, MD, MSc

418-835-7121jerome.patry.1@ulaval.ca

Locations

Hôtel-Dieu de Lévis, CISSS de Chaudière-Appalaches

Recruiting

Lévis, Quebec, Canada, G6V 3Z1

Contacts

Jérôme Patry, DPM, MD, MSc

418-835-7121jerome.patry.1@ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Peripheral Artery Disease
  • Chronic Limb-Threatening Ischemia
  • Home-Based Exercise Therapy
  • Cardiovascular Rehabilitation
  • Pedal Exerciser
  • Peripheral Vascular Disease
  • Exercise Therapy
  • Randomized Controlled Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2026-06-26.