Peripheral Artery DiseasePILOT-PADCYCLENCT07655206
Home-based Exercise Therapy in Patients With Moderate to Severe Peripheral Artery Disease
A study testing Home-Based Exercise Therapy Using Portable Pedal Exerciser in people with Peripheral Artery Disease, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Home-Based Exercise Therapy Using Portable Pedal Exerciser
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jun 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hôtel-Dieu de Lévis, CISSS de Chaudière-Appalaches
Lévis, Quebec, G6V 3Z1
Jérôme Patry, DPM, MD, MSc, 418-835-7121 ext. 11393, jerome.patry.1@ulaval.ca
About this study
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)
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.
Read more
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.
Read the 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:
- HET combined with standard vascular care; or
- 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Home-Based Exercise Therapy Using Portable Pedal Exerciser
- Keywords
- Peripheral Artery Disease, Chronic Limb-Threatening Ischemia, Home-Based Exercise Therapy, Cardiovascular Rehabilitation, Pedal Exerciser, Peripheral Vascular Disease, Exercise Therapy, Randomized Controlled Trial
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Exercise Therapy Using Portable Pedal ExerciserBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based exercise therapy (HET) plus standard care | Experimental | Standard care Receives: Behavioral: Home-Based Exercise Therapy Using Portable Pedal Exerciser |
| Standard Care | No intervention | Usual standard care delivered by their physician for peripheral artery disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the HET Program
Assessment of recruitment rate, adherence to prescribed exercise sessions, intervention completion (in %)
Measured: 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)
Measured: 13 weeks
Acceptability of HET program : qualitative interview findings
Participants acceptability based on a semi-structured interview (no units of measure)
Measured: Between 13 weeks and 25 weeks
Secondary outcomes (6)
Change in 6-Minute Walk Test Distance
Difference in walking distance measured during the 6-minute walk test between baseline and week 13. (in meters)
Measured: Baseline and 13 weeks
Change in peripheral vascular perfusion : ankle-brachial index (ABI)
Difference in ankle-brachial index (ABI) between baseline and week 13 (no units of measure)
Measured: Baseline and 13 weeks
Change in peripheral vascular perfusion : toe-brachial index (TBI)
Difference in toe-brachial index values between baseline and week 13 (no units of measure)
Measured: Baseline and 13 weeks
Change in peripheral vascular perfusion : toe systolic pressure measurements
Difference in toe systolic pressure measurements between baseline and week 13 (mmHg)
Measured: Baseline and 13 weeks
Change in Quality of Life
Changes in quality of life measured using the SF-36 questionnaire.
Measured: Baseline and 13 weeks
Major Cardiovascular Events
Occurrence of any major cardiovascular events (including revascularization, amputation, myocardial infarction, stroke, chronic limb-threatening ischemia progression, and death)
Measured: Up to 6 months after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start23 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- VITAM - Centre de recherche en santé durable, CISSS de Chaudière-Appalaches
- Responsible party
- Principal investigator, Jérôme Patry, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655206
- Sponsor's protocol ID
- CISSSCA-2026-1325
- Acronym
- PILOT-PADCYCLE
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 40850612Patry 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.
PubMed 40935017Iso 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.
PubMed 29750181Cetlin 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.
PubMed 36150636Harwood 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.
PubMed 27126713Thomas 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.
PubMed 31097258Treat-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.
PubMed 30586765Conte 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.
PubMed 31159978Mazzolai 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.
PubMed 38467522Mazzolai 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.
PubMed 39210722Gornik 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.
PubMed 38743805
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07655206
- Acronym / sponsor ID
- PILOT-PADCYCLE / CISSSCA-2026-1325
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- VITAM - Centre de recherche en santé durable, CISSS de Chaudière-Appalaches
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- HET combined with standard vascular care; or
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based exercise therapy (HET) plus standard care | Experimental | Behavioral: Home-Based Exercise Therapy Using Portable Pedal ExerciserStandard care |
| Standard Care | No intervention | –Usual standard care delivered by their physician for peripheral artery disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Exercise Therapy Using Portable Pedal ExerciserParticipants 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. | Behavioural | Home-based exercise therapy (HET) plus standard care |
Primary outcome
Feasibility of the HET Program
Time frame: Baseline and 13 weeks
Assessment of recruitment rate, adherence to prescribed exercise sessions, intervention completion (in %)
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)
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)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 40850612Ahiskali 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.
- Background: PubMed 40935017Patry 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.
- Background: PubMed 29750181Iso 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.
- Background: PubMed 36150636Cetlin 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.
- Background: PubMed 27126713Harwood 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.
- Background: PubMed 31097258Thomas 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.
- Background: PubMed 30586765Treat-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.
- Background: PubMed 31159978Conte 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.
- Background: PubMed 38467522Mazzolai 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.
- Background: PubMed 39210722Mazzolai 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.
- Background: PubMed 38743805Gornik 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Exercise Therapy Using Portable Pedal Exerciser in people with Peripheral Artery Disease, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérôme Patry, DPM, MD, MSc (418-835-7121 ext. 11393, jerome.patry.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the HET Program (time frame: Baseline and 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07655206, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.