Ignite Creation Date:
2024-05-06 @ 1:11 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03951740
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2019-05-06
Brief Title:
Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Cardiac Patients
Sponsor:
Maxima Medical Center
Organization:
Maxima Medical Center
Study Overview
Official Title:
Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Patients With Chronic Heart Failure and Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Improving physical activity is a core component of secondary prevention and cardiac telerehabilitation 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 telerehabilitation 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 heshe 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 075 excellent agreement under the alternative hypothesis that the ICC is 035 poor agreement a sample size of 19 subjects per study group ie 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 p005 for all analyses
Improving physical activity is a core component of secondary prevention and cardiac telerehabilitation 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 heshe 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 075 excellent agreement under the alternative hypothesis that the ICC is 035 poor agreement a sample size of 19 subjects per study group ie 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 p005 for all analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None