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Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Cardiac Patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease Heart Failure With Reduced Ejection Fraction | Device: Fitbit Charge 2 Device: Mio Slice Device: Oxycon Mobile | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 39 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | 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. |
| Masking: | None (Open Label) |
| Masking Description: | Masking not applicable |
| Primary Purpose: | Other |
| Official Title: | Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Patients With Chronic Heart Failure and Coronary Artery Disease. |
| Actual Study Start Date : | October 11, 2017 |
| Actual Primary Completion Date : | June 27, 2018 |
| Actual Study Completion Date : | June 27, 2018 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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.
|
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). |
- 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.
- Responsiveness [ Time Frame: Cycling at three different intensities (3 minutes at each intensity) and treadmill walking at three different intensities (3 minutes at each intensity)) ]Responsiveness (i.e. ability to detect within-patients changes of energy expenditure measurement over time) of the activity trackers will be calculated by using a paired T-test during walking and cycling at different intensities.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | 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
| Netherlands | |
| Máxima Medical Centre | |
| Veldhoven, Noord-Brabant, Netherlands, 5504 DB | |
| Principal Investigator: | Hareld Kemps, MD, PhD | Máxima Medical Centre |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 6, 2019 | ||||
| First Posted Date ICMJE | May 15, 2019 | ||||
| Last Update Posted Date | May 15, 2019 | ||||
| Actual Study Start Date ICMJE | October 11, 2017 | ||||
| Actual Primary Completion Date | June 27, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Responsiveness [ Time Frame: Cycling at three different intensities (3 minutes at each intensity) and treadmill walking at three different intensities (3 minutes at each intensity)) ] Responsiveness (i.e. ability to detect within-patients changes of energy expenditure measurement over time) of the activity trackers will be calculated by using a paired T-test during walking and cycling at different intensities.
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Cardiac Patients. | ||||
| Official Title ICMJE | Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Patients With Chronic Heart Failure and Coronary Artery Disease. | ||||
| 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). 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: 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. Masking: None (Open Label)Masking Description: Masking not applicable Primary Purpose: Other
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: 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.
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
39 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | June 27, 2018 | ||||
| Actual Primary Completion Date | June 27, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion criteria heart failure patients:
Exclusion criteria heart failure patients:
Inclusion criteria patients with coronary artery disease
Exclusion criteria patients with coronary artery disease
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Netherlands | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03951740 | ||||
| Other Study ID Numbers ICMJE | W17.062 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | H.Kemps, Maxima Medical Center | ||||
| Study Sponsor ICMJE | Maxima Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Maxima Medical Center | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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