Functional Parameters Indicative of Heart Failure.

NCT03909919 | Completed

• 1 other identifier: Funnel study
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Kinematics; Validation; Functional task

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• abbreviated comprehensive geriatric assessment (aCGA): a questionnaire formed by items originating from four different scales.

  15 minutes

• SARC-F

  10 minutes

• Cardiopulmonary function

  1 hour

• Quadriceps thickness

  15 minutes

• Quadriceps muscle echo-intensity

  15 minutes

Study Arms (2)

Heart Failure

EXPERIMENTAL

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

Healthy Subjects

ACTIVE COMPARATOR

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

Procedure: Standard Care or Usual Clinical Practice

Interventions

Standard Care or Usual Clinical Practice PROCEDURE

The guidelines for the management according to the heart failure in primary care will be the treatment guidelines for the Standard Care.

Healthy Subjects; Heart Failure

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead
• King's College London: collaborator

Study Sites (1)

School Medicine University of Malaga

Málaga, Malaga, Spain

Location

Related Publications (4)

• Fuentes-Abolafio IJ, Ricci M, Bernal-Lopez MR, Gomez-Huelgas R, Cuesta-Vargas AI, Perez-Belmonte LM. Relationship between quadriceps femoris echotexture biomarkers and muscle strength and physical function in older adults with heart failure with preserved ejection fraction. Exp Gerontol. 2024 Jun 1;190:112412. doi: 10.1016/j.exger.2024.112412. Epub 2024 Apr 6.

  PMID: 38570057 DERIVED

• Fuentes-Abolafio IJ, Trinidad-Fernandez M, Ricci M, Roldan-Jimenez C, Gomez-Huelgas R, Arjona-Caballero JM, Escriche-Escuder A, Bernal-Lopez MR, Perez-Belmonte LM, Cuesta-Vargas AI. Kinematic parameters related to functional capacity, fatigue, and breathlessness during the 6-min walk test in older adults with heart failure with preserved ejection fraction. Eur J Cardiovasc Nurs. 2024 Jan 12;23(1):69-80. doi: 10.1093/eurjcn/zvad027.

  PMID: 36808232 DERIVED

• Fuentes-Abolafio IJ, Bernal-Lopez MR, Gomez-Huelgas R, Ricci M, Cuesta-Vargas AI, Perez-Belmonte LM. Relationship between quadriceps femoris muscle architecture and muscle strength and physical function in older adults with heart failure with preserved ejection fraction. Sci Rep. 2022 Dec 15;12(1):21660. doi: 10.1038/s41598-022-26064-7.

  PMID: 36522418 DERIVED

• 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.

  PMID: 35939260 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Titular Doctor Physiotherapy Department, University of Malaga. Principal investigator.

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 10, 2019
• Study Start: January 18, 2020
• Primary Completion: May 18, 2024
• Study Completion: May 18, 2024
• Last Updated: September 22, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)