HY-PAD: Effect of a Hybrid Rehabilitation Program on Walking, Quality of Life & Cardiovascular Risk in People With PAD
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- 6MWT [at 3 month follow up]
Improvements (increase) in 6 minute walk test total walking distance (meters) after 3 months
Secondary Outcome Measures
- Improvements in quality of life [at 3 month follow up]
Improvement (increase) in accelerometer-measurement MVPA (meters/week), and Improvements in total claudicant distance (meters)
- improvements in Walking Impairment Questionnaire [at 3 month follow up]
Increase in WIQ (Walking Impairment Questionnaire) scores Responses are ranked on a scale of 0 to 4, (0=unable to do, 4=no difficulty)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Intermittent claudication with PAD documented by:
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ABI ≤0.90 or >1.40;(14) or
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Anatomic evidence of lower extremity arterial stenosis ≥50% (by lower extremity angiography, CT angiography, MR angiography or ultrasound)
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Ability to participate in the study (ability to walk)
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Willingness to provide informed consent
Exclusion Criteria:
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They have had previous lower extremity amputation
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They are unable to walk
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They have critical limb ischemia or open lower extremity wounds.
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Patient is unable to read and understand English or French
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Patient is unable, in the opinion of the qualified investigator or referring physician, to comprehend and participate in the exercise intervention.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Ottawa Heart Institute | Ottawa | Ontario | Canada | K1Y 4W7 |
Sponsors and Collaborators
- Ottawa Heart Institute Research Corporation
- AFP Innovation Fund
Investigators
- Principal Investigator: Thais Coutinho, MD, Ottawa Heart Institute Research Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 774