Clinical trial NCT03909919: Functional Parameters Indicative of Heart Failure.
Official title: Functional Parameters Indicative of Heart Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Kinematics
Validation
Functional task
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2019-04-10
Enrollment: 34
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Subjects older than 70 years.
* Healthy subjects and subjects diagnosed with Heart failure.
* Subjects able of filling out questionnaires and performing functional tests.
* subjects who are in a clinical stability and optimal treatment phase.

Exclusion Criteria:

* Participants with cardiac pathologies other than heart failure.
* Score in the NYHA scale equal to 4.
* Hospitalization in a period of time equal to or less than 3 months.
* Score on the Mini-Mental scale below 24.
* Inability to get up from the chair at least 5 times or 30 seconds.
* Inability to walk for 6 minutes.
* Inability to walk independently without a walking assistance device (cane, crutch or walker).
* Subjects participating in an experimental study where they receive a treatment.
* Inability to provide informed consent.

Primary outcomes:
measure: Motion parameters
timeFrame: 1 hour
measure: Kinematic analysis by 3D motion capture
timeFrame: 1 hour
measure: Responsiveness
timeFrame: 1 hour
measure: Reliability
timeFrame: 1 hour
Secondary outcomes:
measure: abbreviated comprehensive geriatric assessment (aCGA): a questionnaire formed by items originating from four different scales.
timeFrame: 15 minutes
measure: SARC-F
timeFrame: 10 minutes
measure: Cardiopulmonary function
timeFrame: 1 hour
measure: Quadriceps thickness
timeFrame: 15 minutes
measure: Quadriceps muscle echo-intensity
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: School Medicine University of Malaga
Study officials:
References:
citation: Fuentes-Abolafio IJ, Ricci M, Bernal-Lopez MR, Gomez-Huelgas R, Cuesta-Vargas AI, Perez-Belmonte LM. Biomarkers and the quadriceps femoris muscle architecture assessed by ultrasound in older adults with heart failure with preserved ejection fraction: a cross-sectional study. Aging Clin Exp Res. 2022 Oct;34(10):2493-2504. doi: 10.1007/s40520-022-02189-7. Epub 2022 Aug 8.