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| Name | Class |
|---|---|
| Medtronic Cardiac Rhythm and Heart Failure | INDUSTRY |
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The aim of this study is to evaluate sit-stand phases and gait speed detection using an externally worn Reveal LINQ (TM) compared to an external reference (3D accelerometer, and/or the Computer Assisted Rehabilitation Environment (CAREN) system) in one center in the Netherlands
Frailty is a geriatric syndrome characterized by reduced homeostatic reserves, exposing the organism to extreme vulnerability to endogenous and exogenous stressors.
Frailty is prevalent in older people and involves a progressive physiological decline of multiple body systems, typical signs and symptoms include weight loss, fatigue, muscle weakness, slow or unsteady gait declines in activity.
Frailty is increasingly recognized as an important prognostic indicator in heart failure (HF) and is more prevalent in HF than the general population.
The identification of frailty in its early stage is important because interventions may potentially prevent, or delay the clinical consequences of frailty.
Of particular focus in this study will be walking speed as prior research has demonstrated that slow gait speed has the strongest prognostic ability of the traditional components used to assess frailty, and has been reported as one of the strongest to predict adverse outcomes, such as mobility disability, falls, or hospitalization.
Also of interest is the detection of posture changes as this may have implications for detecting changes in sleeping habits and could also provide context for other biomarker signals collected by the LINQ device.
The literature has been reviewed and the scientific soundness of the proposed analytical techniques evaluated. The rationale for this study design is to evaluate the feasibility of using the Reveal LINQâ„¢ to monitoring walking patterns.
HF patients (the target population for the study in discussion) would make it possible to test the sensitivity of the accelerometer embedded in the LINQ device in a small cohort of subjects with reduced mobility and for which frailty is more prevalent than the general population, as well as recognized as an important prognostic indicator.
No risk to the subjects is expected with this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Other | Single arm, all the patients enrolled will perform the same walking exercises. On arrival to the rehabilitation center subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, they will be asked to perform the following exercises:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking Exercises-Six Minute Walk (6MW) Test | Other | The Six Minute Walk (6MW) Test measures the distance an individual is able to walk over a total of six minutes on a flat surface. The goal is for the individual to walk as far as possible in six minutes. The Six Minute Walk (6MW) test will be performed within the Computer Assisted Rehabilitation Environment (CAREN) system system environment - single arm |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises | The gait speed will be calculated from the Reveal LINQ accelerometer signals, from the validation accelerometer and / or from the computer assisted rehabilitation system during the walking exercises. We will calculate the average correlation coefficient over all patients and exercises. It is reported as score on a scale, with minimum value= -1 and maximum value = 1. Higher absolute values mean higher correlation. | During walking exercises visit, 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
• Not able to walk continuously for a period of 6 minutes and perform the walking exercises as necessary for the study protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Meijer, | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NUTRIM School of Nutrition and Translational Research in Metabolism of the Faculty Health, Medicine and Life Sciences, Maastricht University, | Maastricht | 6229 | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Patients with Chronic Heart Failure. No control group has been used for this study, but all the patients enrolled will perform the same walking exercises. On arrival to the rehabilitation center subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, they will be asked to perform the following exercises:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2016 | Jun 11, 2018 |
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| Walking Exercises-4 Meter Gait Speed (4MGS) Test | Other | The 4 Meter Gait Speed (4MGS) Test measures the gait speed an individual is able to walk over 4 meters on a flat surface. The goal is for the individual to walk as fast as possible over 4 meters. It will be repeated 3 times within the aforementioned 6MW test (after approximately 1, 3 and 5 minutes) to get variability due to subject tiredness. The test will be performed within the CAREN system environment. - single arm |
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| Walking Exercises-Five Times Sit to Stand (FTSTS) Test | Other | The Five Times Sit to Stand (FTSTS) Test measures the time a subject takes to stand up from an armchair 5 times in a row, without stopping in between. It is a short test which measures dynamic balance and functional mobility - single arm |
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| Walking Exercises-Expanded Timed Get-Up-and-Go (ETGUG) Test | Other | The Expanded Timed Get-Up-and-Go (ETGUG) Test measures the time it takes a subject to stand up from an armchair, walk a distance of 10 m, turn, walk back to the chair, and sit down. It is a short test of basic mobility skills for frail community-dwelling elderly. - single arm |
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| Reveal LINQ accelerometer | Other | Walking exercises test |
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| 3D accelerometer | Other | Walking exercises test |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Patients with Chronic Heart Failure. No control group has been used for this study, but all the patients enrolled will perform the same walking exercises. On arrival to the rehabilitation center, subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, they will be asked to perform the following exercises:
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| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises | The gait speed will be calculated from the Reveal LINQ accelerometer signals, from the validation accelerometer and / or from the computer assisted rehabilitation system during the walking exercises. We will calculate the average correlation coefficient over all patients and exercises. It is reported as score on a scale, with minimum value= -1 and maximum value = 1. Higher absolute values mean higher correlation. | 15 subjects were enrolled and completed the study. All subjects met the inclusion and exclusion criteria. One subject did not have readable device data and as such was excluded from the analysis. | Posted | Number | Correlation Coefficient | During walking exercises visit, 1 Day |
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No adverse event collected in this study
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | Patients with Chronic Heart Failure. No control group has been used for this study, but all the patients enrolled will perform the same walking exercises. On arrival to the rehabilitation center subjects will have the Reveal LINQ, the 3D-accelerometers (one on the chest by medical-grade adhesives and a second at the level of the waist over the top of a medical grade adhesive) and the Holter attached externally. Then, they will be asked to perform the following exercises:
| 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ilaria Marcotullio | Medtronic | +39 06 32814218 | ilaria.marcotullio@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 20, 2017 | Jun 11, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| >=65 years |
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| Average Correlation Across All Exercises |
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