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

NCT03951740 | Completed

• 1 other identifier: W17.062
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction

Keywords

Fitbit Charge 2; Mio Slice; Validation study; Energy expenditure

Outcome Measures

Primary Outcomes (1)

• Agreement

  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.

  During a laboratory protocol consisting of 14 low-to-moderate intensity activities (39 minutes in total, resting time excluded)

Secondary Outcomes (1)

• Responsiveness

  Cycling at three different intensities (3 minutes at each intensity) and treadmill walking at three different intensities (3 minutes at each intensity))

Study Arms (1)

Group of cardiac patients

EXPERIMENTAL

All patients completed the study wearing two wrist-worn activity trackers and the Oxycon mobile as reference method during a laboratory activity protocol.

Device: Fitbit Charge 2; Device: Mio Slice; Device: Oxycon Mobile

Interventions

Fitbit Charge 2 DEVICE

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).

Group of cardiac patients

Mio Slice DEVICE

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).

Group of cardiac patients

Oxycon Mobile DEVICE

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).

Group of cardiac patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hemodynamically significant valvular disease
• Atrial fibrillation
• Peripheral vascular, neurological and orthopaedic conditions impairing exercise capacity
• Severe psychological or cognitive impairments
• Stable coronary artery disease regardless of intervention (PCI or CABG)
• Speaking Dutch language
• 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

Sponsors & Collaborators

• Maxima Medical Center: lead

Study Sites (1)

Máxima Medical Centre

Veldhoven, North Brabant, 5504 DB, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hareld Kemps, MD, PhD

  Maxima Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking not applicable
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, Principal Investigator

Model Details: This is a single-center validation study with a comparative design. Accuracy and responsiveness of two wrist-worn activity trackers will be assessed. 39 patients (19 with coronary artery disease with preserved left ventricular ejection fraction and 19 with heart failure with reduced left ventricular ejection fraction) will be included.

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 15, 2019
• Study Start: October 11, 2017
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)