- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04039620
EAMA Sarcopenia in Acute Care Patients in 9+European Countries (EAMA9+)
Sarcopenia in Acute Care Patients: Protocol for the European Collaboration of Geriatric Surveys: Sarcopenia 9+ European Academy for Medicine of Ageing (EAMA) Project
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Sarcopenia is a nutrition-related disease leading to physical impairment and adverse clinical outcomes. Data regarding its characteristics in hospitalized patients are limited.
Aim: This study will assess in older patients admitted to acute medical wards, the prevalence, incidence, and risk factors for development of sarcopenia, or alteration in its severity, and evaluate associated clinical adverse outcomes.
Methods: This collaboratively-designed, longitudinal prospective observational study will be carried out in patients aged >70 admitted to acute geriatric units in 9 European centers. The new sarcopenia diagnostic criteria of the European Working Group on Sarcopenia 2 (EWGSOP2) will be tested at admission and discharge, using isometric handgrip dynamometry, gait speed, and, pragmatically, calf circumference. There will be 3- and 12-month telephone follow-up (including the SARC-F questionnaire).
Discussion: Our study will be the first collaboration to assess the prevalence and incidence of sarcopenia (EWGSOP2) and its risk factors in hospitalized patients across Europe.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Dolores Sanchez Rodriguez, MD PhD
- Phone Number: +32 493 63 27 50
- Email: dolores.sanchez@uliege.be
Study Contact Backup
- Name: Nele Van Den Noortgate, MD PhD
- Phone Number: +32 476 03 50 96
- Email: nele.vandennoortgate@uzgent.be
Study Locations
-
-
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Barcelona, Spain, 08003
- Sanchez Rodríguez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged >70 admitted to acute hospital medical units
Exclusion Criteria:
- Length of hospital stay anticipated to be <24 hours
- Hip/lower limb fractures
- Major amputations of the lower leg
- Terminally ill patients admitted for palliative care
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of sarcopenia as defined by the European consensus on definition and diagnosis (EWGSOP2)
Time Frame: One year (March 2019-March 2020)
|
Prevalence sarcopenia in acute hospitalized older patients.
|
One year (March 2019-March 2020)
|
Incidence of sarcopenia as defined by the European consensus on definition and diagnosis (EWGSOP2)
Time Frame: One year (March 2019-March 2020)
|
Incidence of sarcopenia in acute hospitalized older patients.
|
One year (March 2019-March 2020)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/8355/I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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