The PaWS (Pedometer and Walking Study)

NCT02510807 | Unknown

• 1 other identifier: 15-8868-BE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Claudication

Outcome Measures

Primary Outcomes (2)

• Increased walking distance

  Six Minute Walk Test

  6 months

• Time to claudication

  Six Minute Walk Test

  6 Months

Secondary Outcomes (3)

• Quality of Life

  6 months

• Ankle Brachial Index

  6 months

• Blood Pressure

  6 months

Study Arms (2)

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.

Other: Pedometer

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.

Interventions

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

Pedometer group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous vascular surgical intervention,
• Non-ambulatory,
• Unstable cardiac status (cardiac event \< 6 months),
• Cognitive difficulties,
• Unwilling to engage in regular exercise

Sponsors & Collaborators

• University Health Network, Toronto: lead
• St. Michael: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

RECRUITING

Related Publications (6)

• 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.

  PMID: 23970372 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.

  PMID: 12477945 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.

  PMID: 17329131 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.

  PMID: 26027632 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.

  PMID: 18029834 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.

  PMID: 12091180 BACKGROUND

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Graham Roche-Nagle, MD

  UHN Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graham Roche-Nagle, MD

CONTACT

+1 4163405332; graham.roche-nagle@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 29, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

CA (1)