The PaWS (Pedometer and Walking Study) (PAWS)
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|ClinicalTrials.gov Identifier: NCT02510807|
Recruitment Status : Unknown
Verified May 2016 by Graham Roche-Nagle, University Health Network, Toronto.
Recruitment status was: Recruiting
First Posted : July 29, 2015
Last Update Posted : May 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Intermittent Claudication||Other: Pedometer||Not Applicable|
It has been established that exercise therapy has a central role in the management of peripheral arterial disease. Such treatment should be comprised of intermittent walking of sufficient distance to induce significant discomfort, and be carried out over a period of at least several months. Supervised exercise training utilizing intermittent treadmill walking is a well-validated treatment for claudication. Most prospective randomized single site studies have reported significant improvement in walking distance following supervised exercise training but not with non-supervised regimens.
Furthermore, this has been acknowledged in both the current AHA/ACC 'Guidelines for the management of patients with peripheral arterial disease', which recommends supervised exercise training as an initial treatment modality with a Class 1A level of evidence (highest), as well as in the TransAtlantic Intersocietal Consensus, which provides an 'A' categorical recommendation. In spite of these peer-reviewed, published recommendations, supervised exercise training remains little used, expensive, not reimbursed by Ontario Health Insurance Plan, and therefore is rarely available to patients with claudication in Ontario.
The purpose of this multicentre study is to examine whether the use of a pedometer enhances patient compliance with walking as compared to usual care.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The PaWS (Pedometer and Walking Study): Comparing Education Alone and Education With Pedometer/Exercise Log Use in Self-monitored Walking in Peripheral Arterial Disease (PAD)|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
Experimental: Pedometer group
Patients will be instructed to walk a minimum of three times per week up to one half hour total walking time. If they started to get pain in their legs, they will be instructed to stop and rest, and then to start again when the pain has subsided. The pedometer group will be instructed to carry the pedometer in their pocket during these exercise periods.
The use of a pedometer will demonstrate improvement in the following health outcomes in patients with PAD by acting as a method of surveillance to improve compliance with a walking regimen
No Intervention: Control group
Patients will be instructed to walk a minimum of three times per week up to one half hour total walking time. If they started to get pain in their legs, they will be instructed to stop and rest, and then to start again when the pain has subsided.
- Increased walking distance [ Time Frame: 6 months ]Six Minute Walk Test
- Time to claudication [ Time Frame: 6 Months ]Six Minute Walk Test
- Quality of Life [ Time Frame: 6 months ]ED5QL and the VascuQol-6 questionnaires
- Ankle Brachial Index [ Time Frame: 6 months ]Ankle Brachial Index
- Blood Pressure [ Time Frame: 6 months ]Blood Pressure
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): NCT02510807
|Contact: Graham Roche-Nagle, MD||+1 firstname.lastname@example.org|
|Toronto General Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G2C4|
|Contact: Graham Roche-Nagle, MD +1 4163405332 email@example.com|
|Principal Investigator:||Graham Roche-Nagle, MD||UHN Toronto|