FRailty WAlking Patterns (FRAP) Study

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

Interventions

OTHER

Walking Exercises-Six Minute Walk (6MW) Test

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

OTHER

Walking Exercises-4 Meter Gait Speed (4MGS) Test

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

OTHER

Walking Exercises-Five Times Sit to Stand (FTSTS) Test

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

OTHER

Walking Exercises-Expanded Timed Get-Up-and-Go (ETGUG) Test

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

OTHER

Reveal LINQ accelerometer

Walking exercises test

OTHER

3D accelerometer

Walking exercises test

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

  collaborator INDUSTRY

• Medtronic BRC

  lead INDUSTRY

Principal Investigators

• Kenneth Meijer, · Maastricht University

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-20

Primary Completion

2017-04-20

Completion

2017-07-20

Countries

• Netherlands

Study Locations