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

Peripheral Arterial Disease Clinical Trial

— HY-PAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03649204
• Other study ID #: 774
• Status: Recruiting
• Start date: July 9, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: Alexandra Dicks
• Phone: 613-696-7000
• Email: adicks[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	AFP Innovation Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6MWT	Improvements (increase) in 6 minute walk test total walking distance (meters) after 3 months	at 3 month follow up
Secondary	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
Secondary	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