FRailty WAlking Patterns (FRAP) Study

NCT02755129 | Completed Results

• 1 other identifier: FRAP1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 Assisted Rehabilitation Environment (CAREN) system) in one center in the Netherlands

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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: * Walking Exercises-4 Meter Gait Speed (4MGS) Test Walking exercises - Six Minute Walk (6MW) Test * Walking exercises - 4 Meter Gait Speed (4MGS) Test * Walking Exercises - Five Times Sit to Stand (FTSTS) Test * Walking Exercises - Expanded Timed Get-Up-and-Go (ETGUG) Test

Other: 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

Interventions

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

single arm

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

single arm

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

single arm

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

single arm

Reveal LINQ accelerometer OTHER

Walking exercises test

single arm

3D accelerometer OTHER

Walking exercises test

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic BRC: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (1)

NUTRIM School of Nutrition and Translational Research in Metabolism of the Faculty Health, Medicine and Life Sciences, Maastricht University,

Maastricht, 6229, Netherlands

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ilaria Marcotullio
• Organization: Medtronic

ilaria.marcotullio@medtronic.com

+39 06 32814218

Study Officials

• Kenneth Meijer,

  Maastricht University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: April 28, 2016
• Study Start: September 20, 2016
• Primary Completion: April 20, 2017
• Study Completion: July 20, 2017
• Last Updated: March 25, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)