Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03909919 |
| Other study ID # |
Funnel study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 18, 2020 |
| Est. completion date |
May 18, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
University of Malaga |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The present study aims to validate the kinematic analysis obtained by two motion capture
instruments for the functional objective assessment of elderly patients with Heart Failire
(HF) and to develop a new functional index formed by kinematic parameters and other
functional objective parameters and scales which may be impaired in patients with HF and they
could allow the stratification of these patients based on different levels of functional
impairment.
Description:
Cardiovascular diseases carried on being the leading cause of disability due to
noncommunicable diseases from 1990 to 2016. Within cardiovascular diseases, it has been
estimated that heart failure (HF) has a prevalence in the population of approximately 2% to
3%. However, it is the only cardiovascular disease that is increasing in incidence and
prevalence due to the aging of the world population, since the prevalence of this disease
increases with age. Furthermore, heart failure represents the most important hospital
diagnosis in older adults, being the main cause of hospital admissions for people older than
65 years and contributing to the increase of medical care costs.
Subjects with HF use to show a reduced aerobic capacity, a decreased muscle strength in the
lower limbs, low weekly physical activity, intolerance to exercise and a lower walking speed
than healthy subjects of the same age. In general, patients with heart failure have altered
functional capacities and experience a decline in the ability to carry out activities of
daily living and suffer a reduced quality of life. When it is assessed functional parameters
in patients with heart failure, the maximum oxygen consumption (V0₂ max) obtained from a
cardiopulmonary exercise test is considered the gold standard measure of cardiovascular
functional capacity. Moreover, some functional tests have been used, such as the 6-Minute
Walking Test, which provides an indirect measure of cardiovascular functional capacity, and
the Short Physical Performance Battery (SPPB), which also provides a useful and indirect
indication of muscle functional capacity. However, at the time of diagnosing or classifying
patients with heart failure, the functional assessment does not use to be considered. The
implementation of diagnostic guidelines or a functional assessment based on evidence can be
important to improve prognosis and quality of life in patients with HF.
Therefore, there is a need to identify functional markers related to functionality that are
indicative of heart failure. For this, it is necessary to use instruments to measure
functional variables that must be valid and reliable, as established by the COSMIN taxonomy.
Kinematic measurements allow quantifying normal and pathological movements, quantifying the
degree of deterioration, planning rehabilitation strategies and evaluating the effect of
various interventions. Inertial sensors and depth cameras are accurate and reliable methods
for the kinematic analysis of human movement, in addition to presenting a good correlation of
kinematic data between them.
Currently, it can be used the Simmer3 Inertial Sensor and 3D motion capture systems with a
camera to analyse kinematics and these instruments are being integrated as a rehabilitation
tool in patients. The use of Shimmer3 Inertial Sensor and 3D motion capture cameras would
help to find fast and cheap assessment methods for professionals.
