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Completed

NCT Number: NCT02837471

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Insititue, Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PiezoRx medical grade pedometer

Device

Participants will be asked to freely use the PiezoRx medical grade pedometer for 12 weeks.

Participants have access to a personal account created online and can record the daily steps count and physical activity.

Participants will receive the standard care by the FrancoForme Cardiovascular rehabilitation and prevention program

Primary outcomes

  1. Change in number of participants who use the PiezoRx device

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    The number of participants who use the device will be defined as the number of participants who create and use the online account during the trial.

  2. Change in frequency of using the PiezoRx device

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    The frequency of usage will be defined as the number of times the participants logon into the online account to upload the steps count and/or physical activity levels.

Secondary outcomes

  1. Changes in moderate to vigorous physical activity time

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    Changes in levels of moderate to vigorous physical activity (in minutes per week) from baseline to follow-ups will be measured by the PiezoRx device.

  2. Number of participants that continue wearing the PiezoRx device beyond the 3 month intervention

    Time frame: One year

    The number of participants who continue wearing the PiezoRx device beyond the 3 month intervention will be defined as the number of participants who continue to use the online account.

  3. Validation of Physical activity questionnaire

    Time frame: One year

    Self-reported physical activity (in minutes/day) using the physical activity questionnaire.

  4. Validation of Physical activity questionnaire

    Time frame: One year

    Self-reported sitting time (in minutes/day) using the physical activity questionnaire.

  5. Analysis of physical activity data (hrs/min) recorded by PiezoRx device and ActiGraph accelerometer and comparing the values.

    Time frame: 7 days

    Data recorded from PiezoRx device and ActiGraph accelerometer will be collected for 7days. Values will be compared to validate the PiezoRx device against the ActiGraph.

  6. Changes in blood pressure

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    Changes in blood pressure (mmHg) from baseline to from baseline to follow-ups

  7. Changes in blood lipids

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    Changes in total cholesterol, HDL, LDL, and Triglycerides (mmol/L) from baseline to follow-ups

  8. Changes in fasting glycosylated hemoglobin

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    Changes in fasting blood HbA1c (%) from baseline to follow-ups

  9. Changes in body weight

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    Changes in body weight (kg) from baseline to follow-ups

  10. Changes in body mass index

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    Changes in BMI (kg/m2) from baseline to follow-ups

  11. Changes in waist circumference

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    Changes in waist circumference (cm) from baseline to follow-ups

  12. Changes in resting heart rate

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    Changes in resting heart rate (bpm) from baseline to follow-ups

  13. Changes in anxiety and depression

    Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)

    Changes in measures of anxiety and depression as assessed using the Hospital Anxiety and Depression Scale from baseline to follow-ups

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • StepsCount Inc

Registry information

Official study title

Assessing the Feasibility and Usability of a Commercial Medical Grade Pedometer in a Case-managed Home-based Primary and Secondary Cardiovascular Disease Prevention Program for French-speaking Canadians (PiezoRx RCT Study)

Acronym: PiezoRx

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2016
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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