Functional Parameters Indicative of Heart Failure.

Heart Failure Clinical Trial

Official title:

Functional Parameters Indicative of Heart Failure.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03909919
• Other study ID #: Funnel study
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2020
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: University of Malaga
• Contact: Antonio Cuesta Vargas, PhD
• Phone: 952137551
• Email: acuesta[@]uma.es
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Standard Care or Usual Clinical Practice
The guidelines for the management according to the heart failure in primary care will be the treatment guidelines for the Standard Care.

Locations

Country	Name	City	State
Spain	School Medicine University of Malaga	Malaga

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaga	King's College London

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motion parameters	Kinematic parameters will be analysed using an inertial sensor included in the Shimmer3 instrument during the performance of different functional task.	1 hour
Primary	Kinematic analysis by 3D motion capture	A camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task.	1 hour
Primary	Responsiveness	The Responsiveness Box of COSMIN checklist will be used to determinate the response to change of the Shimmer 3 Inertial Sensor and the 3D cameras. All possible items will be followed.	1 hour
Primary	Reliability	The Reliability Box of COSMIN checklist will be used to determinate the Test-Retest reliability of the Shimmer3 Inertial Sensor and the 3D cameras. All possible items will be followed.	1 hour
Secondary	abbreviated comprehensive geriatric assessment (aCGA): a questionnaire formed by items originating from four different scales.	Questionnaire used to assess functional, emotional and cognitive components. It is composed of 15 items from the 4 instruments such as the geriatric depression scale (GDS), the Mini-Mental State Examination (MMSE), activities of daily living (ADL) using the Katz index and instrumental activities of daily living (IADL) using the Lawnton & Brody scale. The score varies from 0 to 30 points, giving 1 point to each of the items of the GDS (4 points in total), 12 to the 3 items from the scale of Lawton & Brody, 8 points to the 4 items from the MMSE and 6 points to the 3 items from the Katz index.	15 minutes
Secondary	SARC-F	It is a simple questionnaire to rapidly diagnose Sarcopenia. It is composed by 5 components: Strength, Assistance to walk, Get up from a chair, Climb stairs and Falls. Scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 could predict sarcopenia and poor results.	10 minutes
Secondary	Cardiopulmonary function	The heart rate will be assessed using the ECG Unit of Shimmer3.	1 hour
Secondary	Quadriceps thickness	Muscular thickness will be analysed using the B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan).	15 minutes
Secondary	Quadriceps muscle echo-intensity	Muscle echo-intensity will be analysed using the B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan).	15 minutes