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The PaWS (Pedometer and Walking Study) (PAWS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02510807
Recruitment Status : Unknown
Verified May 2016 by Graham Roche-Nagle, University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : July 29, 2015
Last Update Posted : May 19, 2016
Sponsor:
Collaborator:
St. Michael
Information provided by (Responsible Party):
Graham Roche-Nagle, University Health Network, Toronto

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.

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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

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.



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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510807


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

Locations
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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
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Principal Investigator: Graham Roche-Nagle, MD UHN Toronto
Publications:

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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    Key Record Dates
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:
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Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases