Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Patients With Chronic Heart Failure and Coronary Artery Disease.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 2
- Primary Endpoint
- Agreement
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
Masking not applicable
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •heart failure patients:
- •Patients with heart failure with reduced ejection fraction (LVEF < 40%) due to ischemic or dilating cardiomyopathy
- •New York Heart Association Class II to III
- •Speaking Dutch language
Exclusion Criteria
- •heart failure patients:
- •Hemodynamically significant valvular disease
- •Atrial fibrillation
- •Peripheral vascular, neurological and orthopaedic conditions impairing exercise capacity
- •Severe psychological or cognitive impairments
- •Inclusion criteria patients with coronary artery disease
- •Stable coronary artery disease regardless of intervention (PCI or CABG)
- •Speaking Dutch language
- •Exclusion criteria patients with coronary artery disease
- •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
Arms & Interventions
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.
Intervention: Fitbit Charge 2 (Device)
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.
Intervention: Mio Slice (Device)
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.
Intervention: Oxycon Mobile (Device)
Outcomes
Primary Outcomes
Agreement
Time Frame: During a laboratory protocol consisting of 14 low-to-moderate intensity activities (39 minutes in total, resting time excluded)
Energy expenditure (measured in kcal) will be extracted from both activity trackers for each separate activity of the protocol as well as for the total protocol. Breath-by-breath oxygen uptake (VO2) and carbon dioxide production (VCO2) will be measured during the entire length of the protocol using the Oxycon Mobile (reference method). By using the Weir equation, energy expenditure (kcal) will be calculated from VO2 and VCO2. Agreement of energy expenditure measurement is assessed by using mean differences in energy expenditure measured by the activity trackers versus the Oxycon Mobile and by calculating an intra-class correlation coefficient.
Secondary Outcomes
- Responsiveness(Cycling at three different intensities (3 minutes at each intensity) and treadmill walking at three different intensities (3 minutes at each intensity)))
Investigators
H.Kemps
Cardiologist, Principal Investigator
Maxima Medical Center