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

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ClinicalTrials.gov Identifier: NCT03649204
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
AFP Innovation Fund
Information provided by (Responsible Party):
Thais Coutinho, Ottawa Heart Institute Research Corporation

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 50 participants with PAD. Participants will be randomized to the hybrid walking program (HY-PAD) or to the wait list control group (WLC). If randomized to the HY-PAD group participants will take part in on-site therapist-supervised exercise (3 times/week for weeks 1-4), followed by a home-based exercise program with weekly telephone coaching from an assigned therapist (weeks 5-12). If randomized to the WLC group participants will receive a pamphlet with information about walking for PAD, and continue their usual care.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Behavioral: HY-PAD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HY-PAD

People in the HY-PAD group will participate in the clinical on-site therapist-supervised exercise (3 times/week for weeks 1-4).

At the end of week 4, participants in the HY-PAD group will receive an updated home exercise prescription for the duration of the program (weeks 5-12), following the same principles as above. The therapist will call the participants once a week (15min/call) for weeks 5-12.

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

No Intervention: Wait List Control (WLC)
Participants assigned to the WLC will continue their usual care for the next 12 weeks. After completion of the 3-month follow-up data gathering, WLC participants will be offered the clinical PAD walking program.



Primary Outcome Measures :
  1. 6MWT [ Time Frame: at 3 month follow up ]
    Improvements (increase) in 6 minute walk test total walking distance (meters) after 3 months


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649204


Contacts
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Contact: Alexandra Dicks 613-696-7000 ext 19539 adicks@ottawaheart.ca

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

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Responsible Party: Thais Coutinho, MD, Cheif of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03649204     History of Changes
Other Study ID Numbers: 774
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thais Coutinho, Ottawa Heart Institute Research Corporation:
PAD

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases