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Feasibility and Usability of a Pedometer in a Cardiovascular Disease Prevention Program for French-speaking Canadians (PiezoRx)

U

University of Ottawa Heart Institute

Status

Completed

Conditions

Cardiovascular Disease

Treatments

Device: PiezoRx medical grade pedometer

Study type

Interventional

Funder types

Other

Identifiers

NCT02837471
20160491

Details and patient eligibility

About

The purpose of this prospective randomized controlled trial (RCT) is to evaluate the feasibility and usability of a commercial pedometer and web application in a case-managed home-based Cardiovascular disease prevention and rehabilitation program for French-speaking Canadians.

Full description

A cardiovascular disease (CVD) prevention and rehabilitation program is an evidence-based, standard of care for those who have coronary artery disease or other cardiac conditions; the aim of CVD prevention and rehabilitation program is to minimize disease progression and prevent future cardiovascular events. Behaviour change interventions targeting exercise are effective for improving physical activity levels, but can be intensive and costly. Activity monitors with accompanying web applications may provide a practical compliment to behaviour change interventions as an affordable way to promote and sustain increased physical activity levels, as measured by steps and physical activity levels. To date, no studies have examined the role of a pedometer with accompanying web application on steps and physical activity levels in French-speaking Canadians attending the FrancoForme® cardiac prevention and rehabilitation program at the University of Ottawa Heart Institute. It is also unknown the average daily steps of Canadian Francophone patients. Identifying successful interventions that promote physical activity among CVD prevention and rehabilitation program patients will help to improve their health as well as decrease the risk of first or subsequent cardiovascular events.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Francophone (i.e., French-speaking);
  • ≥18 years;
  • Existing atherosclerotic vascular disease or ≥1 risk factor for CVD (e.g., family history of premature CVD, age [sex dependent], smoking, sedentary lifestyle, diabetes, hypertension, hypercholesterolemia, overweight/obesity);
  • Live in the Champlain Region and attending the onsite FrancoForme® intake;
  • Have a family physician or nurse practitioner (to order blood tests and titrate medications);
  • Patient agrees to sign informed consent.

Exclusion criteria

  • Unwilling to wear activity monitors;
  • Unable to engage in physical activity;
  • Does not have access to the internet;
  • Unable to attend follow-up visits;
  • Unable to provide written, informed consent.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

54 participants in 2 patient groups

Intervention group, PiezoRx device
Experimental group
Description:
Participants will use the PiezoRx pedometer at leisure for 12 weeks, and receive the standard care of the FrancoForme cardiac prevention and rehabilitation program.
Treatment:
Device: PiezoRx medical grade pedometer
Control group, Standard care
No Intervention group
Description:
Participants will receive the standard care of the FrancoForme Cardiovascular disease prevention and rehabilitation program.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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