The PaWS (Pedometer and Walking Study)

Intermittent Claudication Clinical Trial

— PAWS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02510807
• Other study ID #: 15-8868-BE
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2015
• Last updated: May 18, 2016
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: May 2016
• Source: University Health Network, Toronto
• Contact: Graham Roche-Nagle, MD
• Phone: +1 4163405332
• Email: graham.roche-nagle[@]uhn.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Males or females with a diagnosis of PAD (ABI < 0.9) who report symptoms of IC,

• Independent with ambulation (assistive device is permitted) and living independently,

• No previous vascular surgical interventions,

• Fluency in English is preferable but not required,

• Patients need to be willing to return for monthly assessment.

Exclusion Criteria:

• Previous vascular surgical intervention,

• Non-ambulatory,

• Unstable cardiac status (cardiac event < 6 months),

• Cognitive difficulties,

• Unwilling to engage in regular exercise

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease

Intervention

Other:
• Pedometer
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

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	St. Michael

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Stewart KJ, Hiatt WR, Regensteiner JG, Hirsch AT. Exercise training for claudication. N Engl J Med. 2002 Dec 12;347(24):1941-51. Review. — View Citation

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. Review. — View Citation

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. Epub 2007 Feb 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased walking distance	Six Minute Walk Test	6 months	No
Primary	Time to claudication	Six Minute Walk Test	6 Months	No
Secondary	Quality of Life	ED5QL and the VascuQol-6 questionnaires	6 months	No
Secondary	Ankle Brachial Index	Ankle Brachial Index	6 months	No
Secondary	Blood Pressure	Blood Pressure	6 months	No