NCT05113758

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

3.1 years

First QC Date

October 29, 2021

Last Update Submit

August 29, 2023

Conditions

Sarcopenia

Keywords

sarcopeniaultrasoundagedhospitalized

Outcome Measures

Primary Outcomes (3)

  • Prevalence of sarcopenia on admission

    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

    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)

    The evolution of muscle mass between admission and discharge will be assessed by ultrasound

    15 days

Secondary Outcomes (9)

  • Minimal nutritional assessment (MNA-SF) score

    72 hours

  • Hand grip strength

    15 days

  • 4-meter walking speed test

    15 days

  • ADL (Activities of Daily Living) questionnaire

    3 months

  • SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)

    15 days

  • +4 more secondary outcomes

Interventions

muscle ultrasoundDIAGNOSTIC_TEST

All participants will undergo a muscle ultrasound on admission and at discharge

Eligibility Criteria

Age69 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Universitario de Albacete

Albacete, 02006, Spain

Location

Related Publications (2)

  • Lopez Jimenez E, Neira Alvarez M, Menendez Colino R, Checa Lopez M, Grau Jimenez C, Perez Rodriguez P, Vasquez Brolen B, Arias Munana E, Ramirez Martin R, Alonso Bouzon C, Amor Andres MS, Bermejo Boixareu C, Branas F, Alcantud Ibanez M, Alcantud Corcoles R, Cortes Zamora EB, Gomez Jimenez E, Romero Rizos L, Avendano Cespedes A, Hernandez Socorro CR, Abizanda P. Muscle mass loss measured with portable ultrasound in hospitalized older adults: The ECOSARC study. J Nutr Health Aging. 2024 Jan;28(1):100010. doi: 10.1016/j.jnha.2023.100010. Epub 2023 Dec 14.

    PMID: 38267149DERIVED

  • Lopez Jimenez E, Neira Alvarez M, Ramirez Martin R, Alonso Bouzon C, Amor Andres MS, Bermejo Boixareu C, Branas F, Menendez Colino R, Arias Munana E, Checa Lopez M, Grau Jimenez C, Perez Rodriguez P, Alcantud Ibanez M, Vasquez Brolen B, Oliva J, Pena Longobardo LM, Alcantud Corcoles R, Cortes Zamora EB, Gomez Jimenez E, Romero Rizos L, Avendano Cespedes A, Hernandez Socorro CR, Abizanda P. "SARCOPENIA MEASURED BY ULTRASOUND IN HOSPITALIZED OLDER ADULTS" (ECOSARC): multi-centre, prospective observational study protocol. BMC Geriatr. 2023 Mar 22;23(1):163. doi: 10.1186/s12877-023-03891-5.

    PMID: 36949412DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Pedro Abizanda, MD, PhD

    Complejo Hospitalario Universitario de Albacete (SESCAM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 9, 2021

Study Start

May 28, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

ES(1)