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The PaWS (Pedometer and Walking Study) (PAWS)

Primary Purpose

Intermittent Claudication

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pedometer
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pedometer group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Increased walking distance
Six Minute Walk Test
Time to claudication
Six Minute Walk Test

Secondary Outcome Measures

Quality of Life
ED5QL and the VascuQol-6 questionnaires
Ankle Brachial Index
Ankle Brachial Index
Blood Pressure
Blood Pressure

Full Information

First Posted
July 27, 2015
Last Updated
May 18, 2016
Sponsor
University Health Network, Toronto
Collaborators
St. Michael
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1. Study Identification

Unique Protocol Identification Number
NCT02510807
Brief Title
The PaWS (Pedometer and Walking Study)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
St. Michael

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pedometer group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pedometer
Intervention Description
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
Primary Outcome Measure Information:
Title
Increased walking distance
Description
Six Minute Walk Test
Time Frame
6 months
Title
Time to claudication
Description
Six Minute Walk Test
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
ED5QL and the VascuQol-6 questionnaires
Time Frame
6 months
Title
Ankle Brachial Index
Description
Ankle Brachial Index
Time Frame
6 months
Title
Blood Pressure
Description
Blood Pressure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Graham Roche-Nagle, MD
Phone
+1 4163405332
Email
graham.roche-nagle@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham Roche-Nagle, MD
Organizational Affiliation
UHN Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graham Roche-Nagle, MD
Phone
+1 4163405332
Email
graham.roche-nagle@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23970372
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.
Results Reference
background
PubMed Identifier
12477945
Citation
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.
Results Reference
background
PubMed Identifier
17329131
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. doi: 10.1016/j.ejvs.2006.12.030. Epub 2007 Feb 27.
Results Reference
background
PubMed Identifier
26027632
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.
Results Reference
background
PubMed Identifier
18029834
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. doi: 10.1001/jama.298.19.2296.
Results Reference
background
PubMed Identifier
12091180
Citation
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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
Results Reference
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The PaWS (Pedometer and Walking Study)

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