Sarcopenia Measured by Ultrasound in Hospitalized Older Adults

Sarcopenia Clinical Trial

— ECOSARC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113758
• Other study ID #: ABZ-ECO-2018-01
• Status: Completed
• Start date: May 28, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2023
• Source: Complejo Hospitalario Universitario de Albacete
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 69 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Diagnostic Test:
• muscle ultrasound
All participants will undergo a muscle ultrasound on admission and at discharge

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Albacete	Albacete

Sponsors (7)

Lead Sponsor	Collaborator
Pedro Abizanda	Hospital Infanta Sofia, Hospital Universitario Getafe, Hospital Universitario Infanta Leonor, Hospital Universitario La Paz, Hospital Virgen del Valle de Toledo, Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Muscle mass (the anterior rectus femoris muscle)	The evolution of muscle mass between admission and discharge will be assessed by ultrasound	15 days
Secondary	Minimal nutritional assessment (MNA-SF) score	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
Secondary	Hand grip strength	Using a hand-held dynamometer	15 days
Secondary	4-meter walking speed test	The evolution of the value of the 4-meter walking speed test between admission and discharge will be assessed.	15 days
Secondary	ADL (Activities of Daily Living) questionnaire	the ADL questionnaire will also be performed on admission, at discharge, and at 3 months.	3 months
Secondary	SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)	Short Physical Performance Battery (SPPB): score range 0-12, higher score means a better outcome	15 days
Secondary	Mortality	Mortality will be measured with vital status at 3 months.	3 months
Secondary	Length of stay, days	Day of admission to day of discharge	15 days
Secondary	Readmission(s) after index hospitalization	Readmission(s) after index hospitalization, Dichotomous outcome (yes/no)	3 months
Secondary	Emergency department (ED) visit(s)	ED visit(s) after index hospitalization, Dichotomous outcome (yes/no)	3 months