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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
54
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
University of Ottawa Heart Insititue
Ottawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Change in number of participants who use the PiezoRx device
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.
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Change in frequency of using the PiezoRx device
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.
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in moderate to vigorous physical activity time
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.
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Number of participants that continue wearing the PiezoRx device beyond the 3 month intervention
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.
Time frame: One year
Validation of Physical activity questionnaire
Self-reported physical activity (in minutes/day) using the physical activity questionnaire.
Time frame: One year
Validation of Physical activity questionnaire
Self-reported sitting time (in minutes/day) using the physical activity questionnaire.
Time frame: One year
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Analysis of physical activity data (hrs/min) recorded by PiezoRx device and ActiGraph accelerometer and comparing the values.
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.
Time frame: 7 days
Changes in blood pressure
Changes in blood pressure (mmHg) from baseline to from baseline to follow-ups
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in blood lipids
Changes in total cholesterol, HDL, LDL, and Triglycerides (mmol/L) from baseline to follow-ups
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in fasting glycosylated hemoglobin
Changes in fasting blood HbA1c (%) from baseline to follow-ups
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in body weight
Changes in body weight (kg) from baseline to follow-ups
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in body mass index
Changes in BMI (kg/m2) from baseline to follow-ups
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in waist circumference
Changes in waist circumference (cm) from baseline to follow-ups
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in resting heart rate
Changes in resting heart rate (bpm) from baseline to follow-ups
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)
Changes in anxiety and depression
Changes in measures of anxiety and depression as assessed using the Hospital Anxiety and Depression Scale from baseline to follow-ups
Time frame: One year (Baseline to 12 weeks, and baseline to 52 weeks)