Coronary Artery DiseaseNCT03951740
Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Cardiac Patients.
A study testing Fitbit Charge 2, Mio Slice and Oxycon Mobile in people with Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction, run by Maxima Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Fitbit Charge 2, Mio Slice and Oxycon Mobile
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Oct 2017to 27 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Stable coronary artery disease regardless of intervention (PCI or CABG)
- Speaking Dutch language
Who cannot join
- Hemodynamically significant valvular disease
- 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
Show all 9Show fewer
- Atrial fibrillation
- Peripheral vascular, neurological and orthopaedic conditions impairing exercise capacity
- Severe psychological and cognitive impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Patients With Chronic Heart Failure and Coronary Artery Disease.
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.
Read the 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.
- Being tested
- Fitbit Charge 2, Mio Slice, Oxycon Mobile
- Keywords
- Fitbit Charge 2, Mio Slice, Validation study, Energy expenditure
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Charge 2Device
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 SliceDevice
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 MobileDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fitbit Charge 2; Device: Mio Slice; Device: Oxycon Mobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During a laboratory protocol consisting of 14 low-to-moderate intensity activities (39 minutes in total, resting time excluded)
Secondary outcomes (1)
Responsiveness
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.
Measured: Cycling at three different intensities (3 minutes at each intensity) and treadmill walking at three different intensities (3 minutes at each intensity))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start11 Oct 2017
- Primary completion27 Jun 2018
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H.Kemps, Maxima Medical Center
- Investigators
- Hareld Kemps, MD, PhD, Principal investigator, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951740
- Sponsor's protocol ID
- W17.062
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Patients With Chronic Heart Failure and Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT03951740
- Acronym / sponsor ID
- W17.062
- Keywords
- Fitbit Charge 2, Mio Slice, Validation study, Energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group of cardiac patients | Experimental | Device: Fitbit Charge 2, Device: Mio Slice, Device: Oxycon MobileAll patients completed the study wearing two wrist-worn activity trackers and the Oxycon mobile as reference method during a laboratory activity protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Stable coronary artery disease regardless of intervention (PCI or CABG)
- Speaking Dutch language
Key exclusion criteria (9 listed)
- Hemodynamically significant valvular disease
- Atrial fibrillation
- Peripheral vascular, neurological and orthopaedic conditions impairing exercise capacity
- Severe psychological or cognitive impairments
- Left ventricular ejection fraction < 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Charge 2Energy 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 | Group of cardiac patients |
| Mio SliceEnergy 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 | Group of cardiac patients |
| Oxycon MobileThe 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). | Device | Group of cardiac patients |
Primary outcome
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.
1 secondary outcome
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))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hareld Kemps, MD, PhD principal investigator
Maxima Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Charge 2, Mio Slice and Oxycon Mobile in people with Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction, run by Maxima Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement (time frame: During a laboratory protocol consisting of 14 low-to-moderate intensity activities (39 minutes in total, resting time excluded)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.