NCT03951740

Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Cardiac Patients.

Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Patients With Chronic Heart Failure and Coronary Artery Disease.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Maxima Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease
• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DEVICE	Fitbit Charge 2	Energy expenditure (kcal) assessed by this activity tracker will be compared with indirect calorimetry (Oxycon Mobile) during a laboratory activity protocol. Two groups will be assessed: patients with stable coronary artery disease (CAD) and patients with heart failure with reduced ejection fraction (HFrEF).
DEVICE	Mio Slice	Energy expenditure (kcal) assessed by this activity tracker will be compared with indirect calorimetry (Oxycon Mobile) during a laboratory activity protocol. Two groups will be assessed: patients with stable coronary artery disease (CAD) and patients with heart failure with reduced ejection fraction (HFrEF).
DEVICE	Oxycon Mobile	The Oxycon Mobile will be used as the reference method/golden standard to calculate energy expenditure (kcal). This device (consisting of a face mask and gas analyzer unit) will be worn during the entire laboratory activity protocol. Two groups will be assessed: patients with stable coronary artery disease (CAD) and patients with heart failure with reduced ejection fraction (HFrEF).

Timeline

• Start date: 2017-10-11
• Primary completion: 2018-06-27
• Completion: 2018-06-27
• First posted: 2019-05-15
• Last updated: 2019-05-15

Locations

1 site across 1 country: Netherlands