Hybrid rehabilitation program for improving walking and quality of life 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
This study tests a new rehabilitation program that combines supervised exercise with home walking to see if it helps people with Peripheral Arterial Disease walk better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT03649204 on ClinicalTrials.gov |
What this trial studies
This study evaluates a hybrid rehabilitation program designed for individuals with Peripheral Arterial Disease (PAD) that combines on-site supervised exercise with a home-based walking program. The aim is to enhance walking endurance and overall quality of life while addressing cardiovascular risks associated with PAD. By offering a flexible approach, the program seeks to accommodate patients who face barriers to traditional rehabilitation methods. Participants will be monitored for improvements in their walking ability and cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with intermittent claudication due to PAD who can walk and are willing to participate.
Not a fit: Patients who have had previous lower extremity amputations or are unable to walk will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the walking ability and quality of life for patients suffering from PAD.
How similar studies have performed: Previous studies have shown success with both on-site and home-based rehabilitation programs for PAD, indicating that this hybrid approach may also be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ottawa, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Thais Coutinho, MD — Ottawa Heart Institute Research Corporation
- Study coordinator: Alexandra Dicks
- Email: adicks@ottawaheart.ca
- Phone: 613-696-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.