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 : Recruiting
First Posted : August 28, 2018
Last Update Posted : July 24, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||July 9, 2019|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
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.
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.
- 6MWT [ Time Frame: at 3 month follow up ]Improvements (increase) in 6 minute walk test total walking distance (meters) after 3 months
- 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)
- 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)
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
|Contact: Alexandra Dicks||613-696-7000 ext firstname.lastname@example.org|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Contact: Alexandra Dicks 613-696-7000 email@example.com|
|Principal Investigator:||Thais Coutinho, MD||Ottawa Heart Institute Research Corporation|