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

Study Overview
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Brief Summary
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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 50 participants with PAD. Participants will be randomized to the hybrid walking program (HY-PAD) or to the wait list control group (WLC). If randomized to the HY-PAD group participants will take part in on-site therapist-supervised exercise (3 times/week for weeks 1-4), followed by a home-based exercise program with weekly telephone coaching from an assigned therapist (weeks 5-12). If randomized to the WLC group participants will receive a pamphlet with information about walking for PAD, and continue their usual care.

Official Title
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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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Behavioral: HY-PAD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: HY-PAD|Hybrid intervention that includes supervised on-site and home-based components in people with PAD|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWT | Improvements (increase) in 6 minute walk test total walking distance (meters) after 3 months | at 3 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in quality of life | Improvement (increase) in accelerometer-measurement MVPA (meters/week), and Improvements in total claudicant distance (meters) | at 3 month follow up | 
| improvements in Walking Impairment Questionnaire | Increase in WIQ (Walking Impairment Questionnaire) scores Responses are ranked on a scale of 0 to 4, (0=unable to do, 4=no difficulty) | at 3 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD