An interventional study of Home-Based Exercise Therapy Using Portable Pedal Exerciser in Peripheral Artery Disease, sponsored by Laval University. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
Among 43 studies in Peripheral Arterial Disease with a site in Canada — 7 open to participants now, 9 under way, 4 of them phase 3. Peripheral Arterial Disease · Canada.
Among the 43 studies in Peripheral Arterial Disease with a site in Canada, this one is the 30th largest by planned enrollment of the 33 interventional ones that give a count, is the only one that started in 2026, is one of 16 with no phase, and was the 43rd registered.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 12 is below the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →7 of the 43 studies in Peripheral Arterial Disease with a site in Canada are open now.
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 192 Peripheral Arterial Disease studies recruiting now, 138 (72%) set no upper age limit and 9 (5%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →43 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 13
First in 2005; this study’s year is marked. 1 started in 2026.
Median enrollment 126 across the 33 interventional studies, 57 across the 10 observational. Of the 30 that completed or were terminated, 9 (30%) have results posted.
23 of 43 have an industry lead sponsor. The 10 most frequent:
Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.
Laval University has 2 studies filed under Peripheral Arterial Disease — fewer than ten, so there is no comparison to draw.
2 of the studies in Peripheral Arterial Disease with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07655206Laval UniversityHome-based Exercise Therapy in Patients With Moderate to Severe Peripheral Artery Disease | 2026-12-01 |
| NCT04912323R3 Vascular Inc.Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease | 2026-12-31 |
Among the 43 studies in Peripheral Arterial Disease with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
ABI \< 0.6 Ankle systolic pressure \< 70 mmHg Toe systolic pressure \< 40 mmHg Toe-brachial index \< 0.4
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard care
Behavioral: Home-Based Exercise Therapy Using Portable Pedal Exerciser
Usual standard care delivered by their physician for peripheral artery disease
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.
Feasibility of the HET Program
Assessment of recruitment rate, adherence to prescribed exercise sessions, intervention completion (in %)
Time frame: 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)
Time frame: 13 weeks
Acceptability of HET program : qualitative interview findings
Participants acceptability based on a semi-structured interview (no units of measure)
Time frame: Between 13 weeks and 25 weeks
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and 13 weeks
Change in Quality of Life
Changes in quality of life measured using the SF-36 questionnaire.
Time frame: 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)
Time frame: Up to 6 months after completion of the intervention
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 5 months after the start.
Of 260 non-industry interventional studies with no phase under Peripheral Arterial Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 64. This study's planned 5 months is below that.
Counting every sponsor, half of 385 studies reached it within 31 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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