Functional Parameters Indicative of Heart Failure.

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Standard Care or Usual Clinical Practice

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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio Cuesta Vargas, PhD; Phone Number: +34 952137551; Email: acuesta@uma.es

Study Locations

• Spain
  • Malaga, Spain
    • Recruiting
    • School Medicine University of Malaga
    • Contact: Antonio Cuesta-Vargas, PhD; Phone Number: 0034952137551; Email: acuesta@uma.es
    • Principal Investigator: Antonio Cuesta-Vargas, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart Failure; Heart Failure patients Subjects diagnosed with heart faikure, who will receive the best treatment of clinical practice, will be recruited. They must be more than 70 years old.	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.
Active Comparator: Healthy Subjects; Healthy Subjects/ Match control Healthy subjects of the same age as people with heart failure.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Cardiopulmonary function	The heart rate will be assessed using the ECG Unit of Shimmer3.	1 hour
Quadriceps thickness	Muscular thickness will be analysed using the B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan).	15 minutes
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

Collaborators and Investigators

• Sponsor: University of Malaga
• Collaborators: King's College London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2020
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 7, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; Validation; Kinematics; Functional task
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Funnel study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No