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Effect of a Hybrid Rehabilitation Program on Walking, Quality of Life & Cardiovascular Risk in People With PAD

Effect of a Hybrid Rehabilitation Program on Walking, Quality of Life and Cardiovascular Risk in People With Peripheral Arterial Disease (HY-PAD): A Pilot Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03649204
Acronym
HY-PAD
Enrollment
26
Registered
2018-08-28
Start date
2019-07-09
Completion date
2024-10-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

PAD

Brief summary

Peripheral arterial disease (PAD), a disabling condition, affects 800,000 Canadians. People with PAD suffer from poor quality of life due to leg pain, which makes walking difficult. They also have a high risk of heart disease. In November of 2017, the University of Ottawa Heart Institute (UOHI) launched Canada's first specific walking rehabilitation and cardiovascular risk reduction program dedicated to patients with PAD. An on-site, supervised exercise program to improve walking endurance and quality of life in PAD has been shown to be successful. However many patients are not able to participate in the on-site program due to barriers such as transportation, parking, or other commitments. Recently, a home-based walking program has also been shown to significantly improve walking endurance and quality of life among people with PAD. It was decided that a hybrid program, that has a short on-site program followed by a home-based program may allow more patients to participate and have the highest chance of success. The goal is to develop a new hybrid program for medical care in PAD patients in order to: (a) improve their walking distance, (b) improve their quality of life and (c) improve their cardiovascular risk. As part of this study the investigators will enrol 25 participants with PAD. Participants will be studied at baseline (before their first on-site class) and at 3 month follow up (after their last home program phone call).

Interventions

BEHAVIORALHY-PAD

Hybrid intervention that includes supervised on-site and home-based components in people with PAD

Sponsors

Ottawa Heart Institute Research Corporation
Lead SponsorOTHER
AFP Innovation Fund
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Intermittent claudication with PAD documented by: * ABI ≤0.90 or \>1.40;(14) or * Anatomic evidence of lower extremity arterial stenosis ≥50% (by lower extremity angiography, CT angiography, MR angiography or ultrasound) * Ability to participate in the study (ability to walk) * Willingness to provide informed consent

Exclusion criteria

* They have had previous lower extremity amputation * They are unable to walk * They have critical limb ischemia or open lower extremity wounds. * Patient is unable to read and understand English or French * Patient is unable, in the opinion of the qualified investigator or referring physician, to comprehend and participate in the exercise intervention.

Design outcomes

Primary

MeasureTime frameDescription
6MWTat 3 month follow upImprovements (increase) in 6 minute walk test total walking distance (meters) after 3 months

Secondary

MeasureTime frameDescription
Improvements in quality of lifeat 3 month follow upImprovement (increase) in accelerometer-measurement MVPA (meters/week), and Improvements in total claudicant distance (meters)
improvements in Walking Impairment Questionnaireat 3 month follow upIncrease in WIQ (Walking Impairment Questionnaire) scores Responses are ranked on a scale of 0 to 4, (0=unable to do, 4=no difficulty)

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORThais Coutinho, MD

Ottawa Heart Institute Research Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026