Home-based Exercise Therapy in Patients With Moderate to Severe Peripheral Artery Disease
ConditionPeripheral Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaval University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
With or without lower limb wound
Declined referral to an in-person supervised exercise therapy program
Able to provide informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Home-Based Exercise Therapy Using Portable Pedal Exerciser
BehavioralParticipants 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.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Home-based exercise therapy (HET) plus standard careExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility of the HET Program
Assessment of recruitment rate, adherence to prescribed exercise sessions, intervention completion (in %)
Time frame
Baseline and 13 weeks2
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 weeks3
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laval University
Lead sponsor
VITAM - Centre de recherche en santé durable
Collaborator
CISSS de Chaudière-Appalaches
Collaborator
Source ClinicalTrials.gov