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

NCT03649204 | Completed

• 1 other identifier: 774
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Peripheral Arterial Disease

Keywords

PAD

Outcome Measures

Primary Outcomes (1)

• 6MWT

  Improvements (increase) in 6 minute walk test total walking distance (meters) after 3 months

  at 3 month follow up

Secondary Outcomes (2)

• Improvements in quality of life

  at 3 month follow up

• improvements in Walking Impairment Questionnaire

  at 3 month follow up

Interventions

HY-PAD BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who enroll in the UOHI PAD walking program

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• AFP Innovation Fund: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Thais Coutinho, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 28, 2018
• Study Start: July 9, 2019
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CA (1)