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

NCT07655206 | Not Yet Recruiting DMC

• 1 other identifier: CISSSCA-2026-1325
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Feasibility of the HET Program

  Assessment of recruitment rate, adherence to prescribed exercise sessions, intervention completion (in %)

  Baseline and 13 weeks

• Acceptability of the HET program : questionnaire

  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

  Participants acceptability based on a semi-structured interview (no units of measure)

  Between 13 weeks and 25 weeks

Secondary Outcomes (6)

• Change in 6-Minute Walk Test Distance

  Baseline and 13 weeks

• Change in peripheral vascular perfusion : ankle-brachial index (ABI)

  Baseline and 13 weeks

• Change in peripheral vascular perfusion : toe-brachial index (TBI)

  Baseline and 13 weeks

• Change in peripheral vascular perfusion : toe systolic pressure measurements

  Baseline and 13 weeks

• Change in Quality of Life

  Baseline and 13 weeks

Study Arms (2)

Home-based exercise therapy (HET) plus standard care

EXPERIMENTAL

Standard care

Behavioral: Home-Based Exercise Therapy Using Portable Pedal Exerciser

Standard Care

NO INTERVENTION

Usual standard care delivered by their physician for peripheral artery disease

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.

Home-based exercise therapy (HET) plus standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• VITAM - Centre de recherche en santé durable: collaborator
• CISSS de Chaudière-Appalaches: collaborator

Study Sites (1)

Hôtel-Dieu de Lévis, CISSS de Chaudière-Appalaches

Lévis, Quebec, G6V 3Z1, Canada

Location

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.1016/j.jacc.2019.03.008. Epub 2019 May 13.

  PMID: 31097258 BACKGROUND

• 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 American Heart Association. Circulation. 2019 Jan 22;139(4):e10-e33. doi: 10.1161/CIR.0000000000000623. No abstract available.

  PMID: 30586765 BACKGROUND

• 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 BACKGROUND

• Mazzolai L, Belch J, Venermo M, Aboyans V, Brodmann M, Bura-Riviere A, Debus S, Espinola-Klein C, Harwood AE, Hawley JA, Lanzi S, Madaric J, Mahe G, Malatesta D, Schlager O, Schmidt-Trucksass A, Seenan C, Sillesen H, Tew GA, Visona A. Exercise Therapy for Chronic Symptomatic Peripheral Artery Disease: A Clinical Consensus Document of the European Society of Cardiology Working Group on Aorta and Peripheral Vascular Diseases in Collaboration With the European Society of Vascular Medicine and the European Society for Vascular Surgery. Eur J Vasc Endovasc Surg. 2024 Feb 16:S1078-5884(24)00011-X. doi: 10.1016/j.ejvs.2024.01.009. Online ahead of print.

  PMID: 38467522 BACKGROUND

• Mazzolai L, Teixido-Tura G, Lanzi S, Boc V, Bossone E, Brodmann M, Bura-Riviere A, De Backer J, Deglise S, Della Corte A, Heiss C, Kaluzna-Oleksy M, Kurpas D, McEniery CM, Mirault T, Pasquet AA, Pitcher A, Schaubroeck HAI, Schlager O, Sirnes PA, Sprynger MG, Stabile E, Steinbach F, Thielmann M, van Kimmenade RRJ, Venermo M, Rodriguez-Palomares JF; ESC Scientific Document Group. 2024 ESC Guidelines for the management of peripheral arterial and aortic diseases. Eur Heart J. 2024 Sep 29;45(36):3538-3700. doi: 10.1093/eurheartj/ehae179. No abstract available.

  PMID: 39210722 BACKGROUND

• Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR; Peer Review Committee Members. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jun 11;149(24):e1313-e1410. doi: 10.1161/CIR.0000000000001251. Epub 2024 May 14.

  PMID: 38743805 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Jérôme Patry, DPM, MD, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants, clinical staff, and research personnel will be aware of group allocation. Statistical analyses will be conducted while preserving group blinding whenever feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 17, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months following publication and ending 5 years after publication.
• Access Criteria: Researchers who provide a methodologically sound proposal for purposes consistent with the approved study objectives.

Locations

CA (1)