Clinical trial NCT04039620: EAMA Sarcopenia in Acute Care Patients in 9+European Countries
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sarcopenia
Malnutrition
Keywords: Sarcopenia
Malnutrition
EWGSOP2
Older people
Acute care
Hospitalized
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Jagiellonian University
name: Université Libre de Bruxelles
name: Agaplesion Bethesda Clinic Ulm, Ulm, Germany
name: Slagelse Hospital
name: Charles University, Czech Republic
name: NOVA Medical School
name: Karolinska Institutet
name: Catholic University of the Sacred Heart
name: University Hospital, Ghent
name: University of Exeter
First posted: 2019-07-31
Enrollment: 366
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older patients hospitalized in acute care units due to medical processes

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of sarcopenia as defined by the European consensus on definition and diagnosis (EWGSOP2)
timeFrame: One year (March 2019-March 2020)
measure: Incidence of sarcopenia as defined by the European consensus on definition and diagnosis (EWGSOP2)
timeFrame: One year (March 2019-March 2020)
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Sanchez Rodríguez
Study officials:
References:
citation: 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.