The PaWS (Pedometer and Walking Study) (PAWS)

• ClinicalTrials.gov Identifier: NCT02510807
• Recruitment Status: Unknown
• First Posted: July 29, 2015
• Last Update Posted: May 19, 2016
• Sponsor: University Health Network, Toronto
• Collaborator: St. Michael
• Information provided by (Responsible Party): Graham Roche-Nagle, University Health Network, Toronto

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Intermittent Claudication	Other: Pedometer	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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
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.

Outcome Measures

Primary Outcome Measures :

1. Increased walking distance [ Time Frame: 6 months ]
   Six Minute Walk Test
2. Time to claudication [ Time Frame: 6 Months ]
   Six Minute Walk Test

Secondary Outcome Measures :

1. Quality of Life [ Time Frame: 6 months ]
   ED5QL and the VascuQol-6 questionnaires
2. Ankle Brachial Index [ Time Frame: 6 months ]
   Ankle Brachial Index
3. Blood Pressure [ Time Frame: 6 months ]
   Blood Pressure

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Graham Roche-Nagle, MD; +1 4163405332; graham.roche-nagle@uhn.ca

Locations

Canada, Ontario

Toronto General Hospital; Recruiting

Toronto, Ontario, Canada, M5G2C4

Contact: Graham Roche-Nagle, MD +1 4163405332 graham.roche-nagle@uhn.ca

Sponsors and Collaborators

University Health Network, Toronto

St. Michael

Investigators

• Principal Investigator: Graham Roche-Nagle, MD; UHN Toronto

More Information

Publications:

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. Update in: Cochrane Database Syst Rev. 2018 Apr 06;4:CD005263.

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

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.

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.

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.

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. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

• Responsible Party: Graham Roche-Nagle, Vascular Surgeon, University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT02510807
• Other Study ID Numbers: 15-8868-BE
• First Posted: July 29, 2015
• Last Update Posted: May 19, 2016
• Last Verified: May 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Intermittent Claudication; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases