Recruiting

Pedometer & Walking

Sponsor:

University Health Network, Toronto

Code:

NCT02510807

Conditions

Intermittent Claudication

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pedometer

Study Details

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

Study ID

NCT02510807

Start date

Jul, 2015

Status verified date

May, 2016

Completion date

Jul, 2017

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

  • Increased walking distance [ Time Frame: 6 months ]
  • Time to claudication [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Graham Roche-Nagle, MD

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

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G2C4

Contacts

Graham Roche-Nagle, MD

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 19, 2016

Last verified

May, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2016-05-19.