Feasibility and Usability of a Pedometer in a Cardiovascular Disease Prevention Program for French-speaking Canadians
- Conditions
- Cardiovascular Disease
- Interventions
- Device: PiezoRx medical grade pedometer
- Registration Number
- NCT02837471
- Lead Sponsor
- Ottawa Heart Institute Research Corporation
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group, PiezoRx device PiezoRx medical grade pedometer Participants will use the PiezoRx pedometer at leisure for 12 weeks, and receive the standard care of the FrancoForme cardiac prevention and rehabilitation program.
- Primary Outcome Measures
Name Time Method Change in number of participants who use the PiezoRx device 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.
Change in frequency of using the PiezoRx device 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 Outcome Measures
Name Time Method Changes in blood pressure One year (Baseline to 12 weeks, and baseline to 52 weeks) Changes in blood pressure (mmHg) from baseline to from baseline to follow-ups
Analysis of physical activity data (hrs/min) recorded by PiezoRx device and ActiGraph accelerometer and comparing the values. 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.
Changes in moderate to vigorous physical activity time 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.
Number of participants that continue wearing the PiezoRx device beyond the 3 month intervention 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.
Changes in body mass index One year (Baseline to 12 weeks, and baseline to 52 weeks) Changes in BMI (kg/m2) from baseline to follow-ups
Validation of Physical activity questionnaire One year Self-reported sitting time (in minutes/day) using the physical activity questionnaire.
Changes in body weight One year (Baseline to 12 weeks, and baseline to 52 weeks) Changes in body weight (kg) from baseline to follow-ups
Changes in blood lipids 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
Changes in waist circumference One year (Baseline to 12 weeks, and baseline to 52 weeks) Changes in waist circumference (cm) from baseline to follow-ups
Changes in fasting glycosylated hemoglobin One year (Baseline to 12 weeks, and baseline to 52 weeks) Changes in fasting blood HbA1c (%) from baseline to follow-ups
Changes in resting heart rate One year (Baseline to 12 weeks, and baseline to 52 weeks) Changes in resting heart rate (bpm) from baseline to follow-ups
Changes in anxiety and depression 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
Trial Locations
- Locations (2)
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
University of Ottawa Heart Insititue
🇨🇦Ottawa, Ontario, Canada