Heart FailureFRAPNCT02755129
FRailty WAlking Patterns (FRAP) Study
A study testing Walking Exercises-Six Minute Walk (6MW) Test, Walking Exercises-4 Meter Gait Speed (4MGS) Test and Walking Exercises-Five Times Sit to Stand (FTSTS) Test in people with Heart Failure, run by Medtronic BRC at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Walking Exercises-Six Minute Walk (6MW) Test, Walking Exercises-4 Meter Gait Speed (4MGS) Test and Walking Exercises-Five Times Sit to Stand (FTSTS) Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Sep 2016to 20 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
NUTRIM School of Nutrition and Translational Research in Metabolism of the Faculty Health, Medicine and Life Sciences, Maastricht University,
Maastricht, 6229
About this study
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
Read the 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 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 LINQ™ 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.
- Conditions
- Heart Failure
- Being tested
- 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, Reveal LINQ accelerometer
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking Exercises-Six Minute Walk (6MW) TestOther
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
Walking Exercises-4 Meter Gait Speed (4MGS) TestOther
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
Walking Exercises-Five Times Sit to Stand (FTSTS) TestOther
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
Walking Exercises-Expanded Timed Get-Up-and-Go (ETGUG) TestOther
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
Reveal LINQ accelerometerOther
Walking exercises test
3D accelerometerOther
Walking exercises test
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During walking exercises visit, 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start20 Sep 2016
- Primary completion20 Apr 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Responsible party
- Sponsor
- Investigators
- Kenneth Meijer,, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755129
- Sponsor's protocol ID
- FRAP1
- Acronym
- FRAP
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2016
- Last updated
- 25 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRailty WAlking Patterns (FRAP) Study
- ClinicalTrials.gov ID
- NCT02755129
- Acronym / sponsor ID
- FRAP / FRAP1
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 25 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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 LINQ™ 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | 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 accelerometerSingle 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- • Not able to walk continuously for a period of 6 minutes and perform the walking exercises as necessary for the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking Exercises-Six Minute Walk (6MW) TestThe 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 | single arm |
| Walking Exercises-4 Meter Gait Speed (4MGS) TestThe 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 | single arm |
| Walking Exercises-Five Times Sit to Stand (FTSTS) TestThe 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 | single arm |
| Walking Exercises-Expanded Timed Get-Up-and-Go (ETGUG) TestThe 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 | single arm |
| Reveal LINQ accelerometerWalking exercises test | Other | single arm |
| 3D accelerometerWalking exercises test | Other | single arm |
Primary outcome
Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises
Time frame: During walking exercises visit, 1 Day
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Meijer, principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Exercises-Six Minute Walk (6MW) Test, Walking Exercises-4 Meter Gait Speed (4MGS) Test and Walking Exercises-Five Times Sit to Stand (FTSTS) Test in people with Heart Failure, run by Medtronic BRC at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises (time frame: During walking exercises visit, 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.