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The PaWS (Pedometer and Walking Study)

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02510807
Acronym
PAWS
Enrollment
200
Registered
2015-07-29
Start date
2015-07-31
Completion date
2017-07-31
Last updated
2016-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication

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.

Interventions

OTHERPedometer

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

Sponsors

St. Michael
CollaboratorUNKNOWN
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Increased walking distance6 monthsSix Minute Walk Test
Time to claudication6 MonthsSix Minute Walk Test

Secondary

MeasureTime frameDescription
Quality of Life6 monthsED5QL and the VascuQol-6 questionnaires
Ankle Brachial Index6 monthsAnkle Brachial Index
Blood Pressure6 monthsBlood Pressure

Countries

Canada

Contacts

Primary ContactGraham Roche-Nagle, MD
graham.roche-nagle@uhn.ca+1 4163405332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026