Heart Failure Clinical Trial
Official title:
FRailty WAlking Patterns (FRAP) 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
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|