- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05113758
Sarcopenia Measured by Ultrasound in Hospitalized Older Adults (ECOSARC)
"SARCOPENIA MEASURED BY ULTRASOUND IN HOSPITALIZED OLDER ADULTS" (ECOSARC Study).
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Pedro Abizanda, MD, PhD
- Phone Number: +34967597651
- Email: pabizanda@sescam.jccm.es
Study Locations
-
-
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Albacete, Spain, 02006
- Complejo Hospitalario Universitario de Albacete
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Pedro Abizanda, MD, PhD, Complejo Hospitalario Universitario de Albacete (SESCAM)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABZ-ECO-2018-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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