Status:
COMPLETED
FRailty WAlking Patterns (FRAP) Study
Lead Sponsor:
Medtronic BRC
Collaborating Sponsors:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Assist...
Detailed Description
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 peop...
Eligibility Criteria
Inclusion
- Chronic Heart Failure in New York Heart Association (NHYA) class II and class III
- Willing to sign the informed consent form.
- At least 18 years of age.
Exclusion
- • Not able to walk continuously for a period of 6 minutes and perform the walking exercises as necessary for the study protocol.
- Any known allergy to Titanium
- Any concomitant conditions which in the opinion of the investigator would not allow accurate measurement of gait and frailty parameters with an externally worn device.
- Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
- Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
Key Trial Info
Start Date :
September 20 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02755129
Start Date
September 20 2016
End Date
July 20 2017
Last Update
March 25 2020
Active Locations (1)
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1
NUTRIM School of Nutrition and Translational Research in Metabolism of the Faculty Health, Medicine and Life Sciences, Maastricht University,
Maastricht, Netherlands, 6229