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

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).

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: HY-PAD

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Alexandra Dicks; Phone Number: 19539 613-696-7000; Email: adicks@ottawaheart.ca
• Study Contact Backup: Name: Lilly Jean-Pierre; Email: lijean@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Contact: Alexandra Dicks; Phone Number: 613-696-7000; Email: adicks@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who enroll in the UOHI PAD walking program

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: AFP Innovation Fund
• Investigators: Principal Investigator: Thais Coutinho, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PAD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 774

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No