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Functional Parameters Indicative of Heart Failure.

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Standard Care or Usual Clinical Practice
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Heart Failure, Kinematics, Validation, Functional task

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School Medicine University of MalagaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Heart Failure

Healthy Subjects

Arm Description

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.

Healthy Subjects/ Match control Healthy subjects of the same age as people with heart failure.

Outcomes

Primary Outcome Measures

Motion parameters
Kinematic parameters will be analysed using an inertial sensor included in the Shimmer3 instrument during the performance of different functional task.
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.
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.
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.

Secondary Outcome Measures

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.
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.
Cardiopulmonary function
The heart rate will be assessed using the ECG Unit of Shimmer3.
Quadriceps thickness
Muscular thickness will be analysed using the B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan).
Quadriceps muscle echo-intensity
Muscle echo-intensity will be analysed using the B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan).

Full Information

First Posted
April 4, 2019
Last Updated
October 16, 2023
Sponsor
University of Malaga
Collaborators
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT03909919
Brief Title
Functional Parameters Indicative of Heart Failure.
Official Title
Functional Parameters Indicative of Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga
Collaborators
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Kinematics, Validation, Functional task

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart Failure
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Subjects
Arm Type
Active Comparator
Arm Description
Healthy Subjects/ Match control Healthy subjects of the same age as people with heart failure.
Intervention Type
Procedure
Intervention Name(s)
Standard Care or Usual Clinical Practice
Intervention Description
The guidelines for the management according to the heart failure in primary care will be the treatment guidelines for the Standard Care.
Primary Outcome Measure Information:
Title
Motion parameters
Description
Kinematic parameters will be analysed using an inertial sensor included in the Shimmer3 instrument during the performance of different functional task.
Time Frame
1 hour
Title
Kinematic analysis by 3D motion capture
Description
A camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task.
Time Frame
1 hour
Title
Responsiveness
Description
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.
Time Frame
1 hour
Title
Reliability
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
abbreviated comprehensive geriatric assessment (aCGA): a questionnaire formed by items originating from four different scales.
Description
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.
Time Frame
15 minutes
Title
SARC-F
Description
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.
Time Frame
10 minutes
Title
Cardiopulmonary function
Description
The heart rate will be assessed using the ECG Unit of Shimmer3.
Time Frame
1 hour
Title
Quadriceps thickness
Description
Muscular thickness will be analysed using the B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan).
Time Frame
15 minutes
Title
Quadriceps muscle echo-intensity
Description
Muscle echo-intensity will be analysed using the B-mode ultrasonography device (SonoSite 180 Plus, SonoSite Japan, Tokyo, Japan).
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Cuesta Vargas, PhD
Phone
952137551
Ext
+34
Email
acuesta@uma.es
Facility Information:
Facility Name
School Medicine University of Malaga
City
Malaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Cuesta-Vargas, PhD
Phone
0034952137551
Email
acuesta@uma.es
First Name & Middle Initial & Last Name & Degree
Antonio Cuesta-Vargas, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35939260
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.
Results Reference
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Functional Parameters Indicative of Heart Failure.

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