Trial Outcomes & Findings for FRailty WAlking Patterns (FRAP) Study (NCT NCT02755129)
NCT ID: NCT02755129
Last Updated: 2020-03-25
Results Overview
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.
COMPLETED
NA
15 participants
During walking exercises visit, 1 Day
2020-03-25
Participant Flow
Participant milestones
| Measure |
All Study Participants
Patients with Chronic Heart Failure. No control group has been used for this study, but 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 - 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
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|---|---|
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Overall Study
STARTED
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15
|
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Overall Study
COMPLETED
|
15
|
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Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=15 Participants
Patients with Chronic Heart Failure. No control group has been used for this study, but 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 - 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
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=15 Participants
|
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Age, Categorical
>=65 years
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10 Participants
n=15 Participants
|
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Sex: Female, Male
Female
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4 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
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11 Participants
n=15 Participants
|
|
Region of Enrollment
Netherlands
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15 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: During walking exercises visit, 1 DayPopulation: 15 subjects were enrolled and completed the study. All subjects met the inclusion and exclusion criteria. One subject did not have readable device data and as such was excluded from the analysis.
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.
Outcome measures
| Measure |
Correlation Coefficient - Six Minute Walk (6MW) Test
n=14 Participants
Patients with Chronic Heart Failure. No control group used. All patients enrolled performed 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, the correlation coefficient for gait speed across devices for Six Minute Walk (6MW) Test is calculated.
|
Correlation Coefficient - 4 Meter Gait Speed (4MGS) Test
n=14 Participants
Patients with Chronic Heart Failure. No control group used. All patients enrolled performed 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, the correlation coefficient for gait speed across devices for 4 Meter Gait Speed (4MGS) Test is calculated.
|
Correlation Coefficient - Five Times Sit to Stand (FTSTS) Test
n=14 Participants
Patients with Chronic Heart Failure. No control group used. All patients enrolled performed 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, the correlation coefficient for gait speed across devices for Five Times Sit to Stand (FTSTS) Test is calculated.
|
Correlation Coefficient - ETGUG Test
n=14 Participants
Patients with Chronic Heart Failure. No control group used. All patients enrolled performed 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, the correlation coefficient for gait speed across devices for Expanded Timed Get-Up-and-Go (ETGUG) Test is calculated.
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|---|---|---|---|---|
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Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises
Correlation per each Exercise
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0.97 Correlation Coefficient
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0.93 Correlation Coefficient
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0.86 Correlation Coefficient
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0.91 Correlation Coefficient
|
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Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises
Average Correlation Across All Exercises
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0.91 Correlation Coefficient
|
0.91 Correlation Coefficient
|
0.91 Correlation Coefficient
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0.91 Correlation Coefficient
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Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place