N/A
N=15
FRailty WAlking Patterns (FRAP) Study
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02755129 ↗Enrolled (actual)
15
Serious AEs
—
Results posted
Mar 2020
Primary outcome: Primary: Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises — 0.97; 0.93; 0.86; 0.91 Correlation Coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Walking Exercises-Six Minute Walk (6MW) Test (Other); Walking Exercises-4 Meter Gait Speed (4MGS) Test (Other); Walking Exercises-Five Times Sit to Stand (FTSTS) Test (Other); Walking Exercises-Expanded Timed Get-Up-and-Go (ETGUG) Test (Other); Reveal LINQ accelerometer (Other); 3D accelerometer (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic BRC
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises |
0.97; 0.93; 0.86; 0.91; 0.91; 0.91 | — |
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 Assisted Rehabilitation Environment (CAREN) system) in one center in the Netherlands
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- • 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.
Data sourced from ClinicalTrials.gov (NCT02755129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.