Intermittent ClaudicationPAWSNCT02510807
The PaWS (Pedometer and Walking Study)
A study testing Pedometer in people with Intermittent Claudication, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- Pedometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous vascular surgical intervention,
- Non-ambulatory,
- Unstable cardiac status (cardiac event < 6 months),
- Cognitive difficulties,
- Unwilling to engage in regular exercise
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G2C4
Graham Roche-Nagle, MD, +1 4163405332, graham.roche-nagle@uhn.ca
About this study
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)
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.
Read the 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.
- Conditions
- Intermittent Claudication
- Being tested
- Pedometer
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PedometerOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased walking distance
Six Minute Walk Test
Measured: 6 months
Time to claudication
Six Minute Walk Test
Measured: 6 Months
Secondary outcomes (3)
Quality of Life
ED5QL and the VascuQol-6 questionnaires
Measured: 6 months
Ankle Brachial Index
Ankle Brachial Index
Measured: 6 months
Blood Pressure
Blood Pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- St. Michael
- Responsible party
- Principal investigator, Graham Roche-Nagle, University Health Network, Toronto
- Investigators
- Graham Roche-Nagle, MD, Principal investigator, UHN Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510807
- Sponsor's protocol ID
- 15-8868-BE
- Acronym
- PAWS
- Status last verified
- May 2016
- First submitted
- 27 Jul 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 23970372Stewart 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.
PubMed 12477945Wind 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.
PubMed 17329131Vemulapalli 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.
PubMed 26027632Bravata 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.
PubMed 18029834ATS 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.
PubMed 12091180
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02510807
- Acronym / sponsor ID
- PAWS / 15-8868-BE
- Conditions
- Intermittent Claudication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- St. Michael
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedometer group | Experimental | Other: PedometerPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Previous vascular surgical intervention,
- Non-ambulatory,
- Unstable cardiac status (cardiac event < 6 months),
- Cognitive difficulties,
- Unwilling to engage in regular exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PedometerThe 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 | Other | Pedometer group |
Primary outcome
Increased walking distance
Time frame: 6 months
Six Minute Walk Test
Time to claudication
Time frame: 6 Months
Six Minute Walk Test
3 secondary outcomes
Quality of Life
Time frame: 6 months
Ankle Brachial Index
Time frame: 6 months
Blood Pressure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Background: PubMed 23970372Fokkenrood 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.
- Background: PubMed 12477945Stewart 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.
- Background: PubMed 17329131Wind 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.
- Background: PubMed 26027632Vemulapalli 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.
- Background: PubMed 18029834Bravata 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.
- Background: PubMed 12091180ATS 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Roche-Nagle, MD principal investigator
UHN Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer in people with Intermittent Claudication, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Graham Roche-Nagle, MD (+1 4163405332, graham.roche-nagle@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased walking distance (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02510807, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.