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

Official title

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)

Overview

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.

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.

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

Primary outcome measures

• 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]

Secondary outcome measures (6)

• Change in 6-Minute Walk Test Distance [Time frame: Baseline and 13 weeks]
• Change in peripheral vascular perfusion : ankle-brachial index (ABI) [Time frame: Baseline and 13 weeks]
• Change in peripheral vascular perfusion : toe-brachial index (TBI) [Time frame: Baseline and 13 weeks]
• Change in peripheral vascular perfusion : toe systolic pressure measurements [Time frame: Baseline and 13 weeks]
• Change in Quality of Life [Time frame: Baseline and 13 weeks]
• Major Cardiovascular Events [Time frame: Up to 6 months after completion of the intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Hôtel-Dieu de Lévis, CISSS de Chaudière-Appalaches — Lévis

Publications

• Ahiskali GN, Demirel A, Yamikan H, Kutukcu EC. The effects of upper extremity and lower extremity aerobic exercise training in patients with peripheral arterial disease: A systematic review. J Vasc Surg. 2026 Jan;83(1):305-316.e2. doi: 10.1016/j.jvs.2025.07.060. Epub 2025 Aug 23. PMID 40850612
• Patry J, Hebert AA, Ross MK. Should We Prescribe a Pedal Exerciser for Every Patient With Peripheral Artery Disease? A Low-Cost Tool Against High-Stakes Complications. Can J Cardiol. 2025 Dec;41(12):2627-2628. doi: 10.1016/j.cjca.2025.09.003. Epub 2025 Sep 9. No abstract available. PMID 40935017
• Iso Y, Suzuki H, Kyuno E, Maeda A, Tsunoda F, Miyazawa R, Kowaita H, Kitai H, Takahashi T, Sambe T. Therapeutic potential of cycling high-intensity interval training in patients with peripheral artery disease: A pilot study. Int J Cardiol Heart Vasc. 2018 Feb 21;18:30-32. doi: 10.1016/j.ijcha.2018.02.002. eCollection 2018 Mar. No abstract available. PMID 29750181
• Cetlin MD, Polonsky T, Ho K, Zhang D, Tian L, Zhao L, Greenland P, Treat-Jacobson D, Kibbe MR, Criqui MH, Guralnik JM, McDermott MM. Barriers to participation in supervised exercise therapy reported by people with peripheral artery disease. J Vasc Surg. 2023 Feb;77(2):506-514. doi: 10.1016/j.jvs.2022.09.014. Epub 2022 Sep 20. PMID 36150636
• Harwood AE, Smith GE, Cayton T, Broadbent E, Chetter IC. A Systematic Review of the Uptake and Adherence Rates to Supervised Exercise Programs in Patients with Intermittent Claudication. Ann Vasc Surg. 2016 Jul;34:280-9. doi: 10.1016/j.avsg.2016.02.009. Epub 2016 Apr 25. PMID 27126713
• Thomas RJ, Beatty AL, Beckie TM, Brewer LC, Brown TM, Forman DE, Franklin BA, Keteyian SJ, Kitzman DW, Regensteiner JG, Sanderson BK, Whooley MA. Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. J Am Coll Cardiol. 2019 Jul 9;74(1):133-153. d PMID 31097258
• Treat-Jacobson D, McDermott MM, Bronas UG, Campia U, Collins TC, Criqui MH, Gardner AW, Hiatt WR, Regensteiner JG, Rich K; American Heart Association Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Council on Cardiovascular and Stroke Nursing. Optimal Exercise Programs for Patients With Peripheral Artery Disease: A Scientific Statement From the America PMID 30586765
• Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH; GVG Writing Group. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019 Jun;69(6S):3S-125S.e40. doi: 10.1016/j.jvs.2019.02.016. Epub 2019 May 28. PMID 31159978

Identifiers

NCT: NCT07655206 · CISSSCA-2026-1325

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗