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| Name | Class |
|---|---|
| St. Michael | UNKNOWN |
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The literature has shown that supervised exercise programs for patients with PAD and who report intermittent claudication (IC) have improved health outcomes, but this is not locally available. Introducing the use of a pedometer may act as a method to encourage patients to continue on their independent exercise regimen. There is very little literature which has examined the effectiveness using pedometers as a measure of compliance within this population.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pedometer group | Experimental | 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. |
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| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedometer | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Increased walking distance | Six Minute Walk Test | 6 months |
| Time to claudication | Six Minute Walk Test | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | ED5QL and the VascuQol-6 questionnaires | 6 months |
| Ankle Brachial Index | Ankle Brachial Index | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Graham Roche-Nagle, MD | Contact | +1 4163405332 | graham.roche-nagle@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Graham Roche-Nagle, MD | UHN Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Recruiting | Toronto | Ontario | M5G2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23970372 | Background | Fokkenrood HJ, Bendermacher BL, Lauret GJ, Willigendael EM, Prins MH, Teijink JA. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2013 Aug 23;(8):CD005263. doi: 10.1002/14651858.CD005263.pub3. | |
| 12477945 | Background | Stewart KJ, Hiatt WR, Regensteiner JG, Hirsch AT. Exercise training for claudication. N Engl J Med. 2002 Dec 12;347(24):1941-51. doi: 10.1056/NEJMra021135. No abstract available. |
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| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Blood Pressure | Blood Pressure | 6 months |
| 17329131 | Background | Wind J, Koelemay MJ. Exercise therapy and the additional effect of supervision on exercise therapy in patients with intermittent claudication. Systematic review of randomised controlled trials. Eur J Vasc Endovasc Surg. 2007 Jul;34(1):1-9. doi: 10.1016/j.ejvs.2006.12.030. Epub 2007 Feb 27. |
| 26027632 | Background | Vemulapalli S, Dolor RJ, Hasselblad V, Schmit K, Banks A, Heidenfelder B, Patel MR, Jones WS. Supervised vs unsupervised exercise for intermittent claudication: A systematic review and meta-analysis. Am Heart J. 2015 Jun;169(6):924-937.e3. doi: 10.1016/j.ahj.2015.03.009. Epub 2015 Mar 26. |
| 18029834 | Background | Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296. |
| 12091180 | Background | ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |