EAMA Sarcopenia in Acute Care Patients in 9+European Countries

Sarcopenia Clinical Trial

— EAMA9+  

Official title:

Sarcopenia in Acute Care Patients: Protocol for the European Collaboration of Geriatric Surveys: Sarcopenia 9+ European Academy for Medicine of Ageing (EAMA) Project

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04039620
• Other study ID #: 2018/8355/I
• Status: Terminated
• Start date: March 6, 2019
• Est. completion date: April 2, 2023

Study information

• Verified date: April 2023
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This collaborative study in 9 geriatrics units across Europe aims to apply emerging research to clinical practice, following the "Action-Research Philosophy" (11). The overall goal is to improve care in patients with - and help prevent - sarcopenia. Understanding the frequency of and risk factors for developing sarcopenia in an acute hospital setting, may help shed light on potential interventions and thus inform the development of future therapeutic strategies. It involves crucial implications for research, clinical practice, and policy towards optimal aging.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 366
• Est. completion date: April 2, 2023
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Sarcopenia

Intervention

Other:
• Observational study, no interventions expected
No interventions are planned

Locations

Country	Name	City	State
Spain	Sanchez Rodríguez	Barcelona

Sponsors (11)

Lead Sponsor	Collaborator
Parc de Salut Mar	Agaplesion Bethesda Clinic Ulm, Ulm, Germany, Catholic University of the Sacred Heart, Charles University, Czech Republic, Jagiellonian University, Karolinska Institutet, NOVA Medical School, Slagelse Hospital, Université Libre de Bruxelles, University Hospital, Ghent, University of Exeter

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Sanchez-Rodriguez D, Hope S, Piotrowicz K, Benoit F, Czesak J, Dallmeier D, Decker G, De Spiegeleer A, Hojmann AH, Hrnciarikova D, Marco E, Mendes D, Meza D, Nascimento P, Rodrigues A, Surquin M, Toscano-Rico M, Vankova H, Vetrano DL, Gasowski J, Van Den Noortgate N, Landi F. Sarcopenia in Acute Care Patients: Protocol for the European Collaboration of Geriatric Surveys: Sarcopenia 9+ EAMA Project. J Am Med Dir Assoc. 2019 Nov;20(11):e1-e3. doi: 10.1016/j.jamda.2019.04.030. Epub 2019 Jun 21. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of sarcopenia as defined by the European consensus on definition and diagnosis (EWGSOP2)	Prevalence sarcopenia in acute hospitalized older patients.	One year (March 2019-March 2020)
Primary	Incidence of sarcopenia as defined by the European consensus on definition and diagnosis (EWGSOP2)	Incidence of sarcopenia in acute hospitalized older patients.	One year (March 2019-March 2020)

External Links

•   Sarcopenia in Acute Care Patients: Protocol for the European Collaboration of Geriatric Surveys: Sarcopenia 9+ EAMA Project.