Coronary Artery Disease Clinical Trial
Official title:
Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Patients With Chronic Heart Failure and Coronary Artery Disease.
Improving physical activity is a core component of secondary prevention and cardiac (tele)rehabilitation. Commercially available activity trackers are frequently used to monitor and promote physical activity in cardiac patients. However studies on the validity of these devices in cardiac patients are scarce. The aim of this study is to determine the accuracy and responsiveness of two wrist-worn activity trackers, Fitbit Charge 2 (FC2) and Mio Slice (MS), for the assessment of energy expenditure (EE) in cardiac patients.
Introduction
Improving physical activity is a core component of secondary prevention and cardiac
(tele)rehabilitation. Commercially available activity trackers are frequently used to monitor
and promote physical activity in cardiac patients. However studies on the validity of these
devices in cardiac patients are scarce. The aim of this study is to determine the accuracy
and responsiveness of two wrist-worn activity trackers, Fitbit Charge 2 (FC2) and Mio Slice
(MS), for the assessment of energy expenditure (EE) in cardiac patients.
Methods
Eligible patients are recruited by their cardiologist in the outpatient cardiology clinic. If
a patient is willing to participate, he/she visits the Máxima Medical Centre once, to perform
the study measurements.
EE assessed by both activity trackers is compared with indirect calorimetry (Oxycon Mobile)
during a laboratory activity protocol consisting of 14 low-to-moderate intensity activities.
The duration of the activities varies between 1 to 5 minutes, while total duration of the
protocol is 39 minutes (resting time excluded) Two groups are assessed: patients with stable
coronary artery disease (CAD) and patients with heart failure with reduced ejection fraction
(HFrEF).
Sample size calculation
To achieve 80% power to detect an intraclass correlation coefficient (ICC) of 0.75 (excellent
agreement) under the alternative hypothesis that the ICC is 0.35 (poor agreement), a sample
size of 19 subjects per study group (i.e. CAD and HFrEF) is calculated.
Statistical analysis
Accuracy of FC2 and MS will be assessed by calculating mean EE and mean differences in EE
compared to the criterion measure (Oxycon Mobile). To identify if agreement is between
reasonable limits one-sample T-tests will be performed using mean differences. In addition,
Bland-Altman plots will be created to illustrate the level of agreement with mean bias and
95% upper and lower limits of agreement (LoA). Moreover ICC using two-way mixed models with
absolute agreement will used. Responsiveness of FC2 and MS will be assessed by using a paired
T-test during walking and cycling at different intensities. Significance level will be set at
p<0.05 for all analyses.
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