Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Cardiac Patients.
NCT ID: NCT03951740
Last Updated: 2019-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2017-10-11
2018-06-27
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Group of cardiac patients
All patients completed the study wearing two wrist-worn activity trackers and the Oxycon mobile as reference method during a laboratory activity protocol.
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).
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).
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).
Interventions
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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).
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).
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).
Eligibility Criteria
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Inclusion Criteria
* New York Heart Association Class II to III
* Speaking Dutch language
* Stable coronary artery disease regardless of intervention (PCI or CABG)
* Speaking Dutch language
Exclusion Criteria
* Atrial fibrillation
* Peripheral vascular, neurological and orthopaedic conditions impairing exercise capacity
* Severe psychological or cognitive impairments
* Left ventricular ejection fraction \< 50%
* Hemodynamically significant valvular disease
* Atrial fibrillation
* Peripheral vascular, neurological and orthopaedic conditions impairing exercise capacity
* Severe psychological and cognitive impairments
18 Years
ALL
No
Sponsors
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Maxima Medical Center
OTHER
Responsible Party
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H.Kemps
Cardiologist, Principal Investigator
Principal Investigators
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Hareld Kemps, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maxima Medical Center
Locations
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Máxima Medical Centre
Veldhoven, North Brabant, Netherlands
Countries
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Other Identifiers
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W17.062
Identifier Type: -
Identifier Source: org_study_id
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