Sarcopenia Measured by Ultrasound in Hospitalized Older Adults (ECOSARC)

August 29, 2023 updated by: Pedro Abizanda

"SARCOPENIA MEASURED BY ULTRASOUND IN HOSPITALIZED OLDER ADULTS" (ECOSARC Study).

Observational prospective study in older adults admitted to an Acute Geriatric Unit, in which sarcopenia will be evaluated by ultrasound in the anterior rectus femoris muscle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of the study is to estimate, by means of portable ultrasound, parameters of muscle quantity and quality (anterior rectus femoris muscle area, width and echostructure ) in older adults hospitalized in Acute Geriatric Units for medical reasons.

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Albacete, Spain, 02006
        • Complejo Hospitalario Universitario de Albacete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

69 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients over 69 years of age admitted to Acute Geriatric Units.

Description

Inclusion Criteria:

  • Patients over 69 years of age.
  • Hospitalization for a medical cause in Acute Geriatric Units.
  • Holden's Functional Ambulation Classification Scale at level 1 or higher.
  • Informed consent signed by the patient or legal representative.

Exclusion Criteria:

  • Terminal condition or life expectancy of less than 6 months.
  • Impossibility or refusal to undergo muscle ultrasound.
  • Refusal for follow-up
  • Severe dementia stage Global Deteriorating Scale: 7
  • Impossibility in the opinion of the investigators to complete the necessary data for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of sarcopenia on admission
Time Frame: 72 hours
Prevalence of sarcopenia on admission. A prevalent case of sarcopenia will be considered if a patient fulfills the EWGSOP2 at admission
72 hours
Incidence of sarcopenia between admission and discharge
Time Frame: 15 days
An incident case of sarcopenia will be considered if a patient not fulfilling EWGSOP2 diagnostic criteria on admission, will meet diagnostic criteria at discharge of sarcopenia at discharge (diagnosis will be considered as a dichotomous variable -yes/no-).
15 days
Muscle mass (the anterior rectus femoris muscle)
Time Frame: 15 days
The evolution of muscle mass between admission and discharge will be assessed by ultrasound
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal nutritional assessment (MNA-SF) score
Time Frame: 72 hours

The mini-nutritional assessment - short form is a simple, non - invasive and validated scale for the detection of malnutrition in older adults. It takes into account the patient's loss of appetite, weight loss, motor skills, recent health status, neuropsychological disorders. The maximum score of the MNA-SF is 14:

Greater than or equal to 11: normal nutritional status. Between 8 and 11: risk of malnutrition. Less than 8: malnutrition.

72 hours
Hand grip strength
Time Frame: 15 days
Using a hand-held dynamometer
15 days
4-meter walking speed test
Time Frame: 15 days
The evolution of the value of the 4-meter walking speed test between admission and discharge will be assessed.
15 days
ADL (Activities of Daily Living) questionnaire
Time Frame: 3 months
the ADL questionnaire will also be performed on admission, at discharge, and at 3 months.
3 months
SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)
Time Frame: 15 days
Short Physical Performance Battery (SPPB): score range 0-12, higher score means a better outcome
15 days
Mortality
Time Frame: 3 months
Mortality will be measured with vital status at 3 months.
3 months
Length of stay, days
Time Frame: 15 days
Day of admission to day of discharge
15 days
Readmission(s) after index hospitalization
Time Frame: 3 months
Readmission(s) after index hospitalization, Dichotomous outcome (yes/no)
3 months
Emergency department (ED) visit(s)
Time Frame: 3 months
ED visit(s) after index hospitalization, Dichotomous outcome (yes/no)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Pedro Abizanda, MD, PhD, Complejo Hospitalario Universitario de Albacete (SESCAM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2019

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

October 29, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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