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Completed

NCT Number: NCT03649204

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

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).

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HY-PAD

Behavioral

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

Primary outcomes

  1. 6MWT

    Time frame: at 3 month follow up

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

Secondary outcomes

  1. Improvements in quality of life

    Time frame: at 3 month follow up

    Improvement (increase) in accelerometer-measurement MVPA (meters/week), and Improvements in total claudicant distance (meters)

  2. improvements in Walking Impairment Questionnaire

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • AFP Innovation Fund

Registry information

Official study 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

Acronym: HY-PAD

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2018
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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