Sarcopenia in Acute Care Patients: Protocol for the European Collaboration of Geriatric Surveys: Sarcopenia 9+ European Academy for Medicine of Ageing (EAMA) Project
Conditions: Sarcopenia, Malnutrition
Sponsor: Parc de Salut Mar

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Sarcopenia in acute care patients: Protocol for the 
European Collaboration of Geriatric Surveys: 
Sarcopenia 9+ EAMA project 
 
Updated version 2019.07.29 for ClinicalTrials.gov 
 
 
 

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Sarcopenia in acute care patients: Protocol for the European Collaboration of 
Geriatric Surveys: Sarcopenia 9+ EAMA project 
Dolores Sanchez-Rodriguez MD PhD1-4; Suzy Hope MBChB PhD5,6; Karolina 
Piotrowicz MD PhD7,8; Florence Benoit MD9; Joanna Czesak PT PhD10,11; Dhayana 
Dallmeier MD PhD12,13; Genia Decker12; Anton De Spiegeleer MD14; Anette Hansen 
Højmann MD PhD15; Dana Hrnciarikova MD PhD16; Ester Marco MD PhD2,17,18,19; 
Diana Mendes Nutr. MsC20,21; Delky Meza MD2,4; Paula Nascimento MD20,21; Afonso 
Rodrigues MD20,21; Murielle Surquin MD PhD10; Miguel Toscano-Rico MD20,21; Hana 
Vankova MD PhD22; Davide L.Vetrano MD PhD23,24; Jerzy Gąsowski MD, PhD8,9; 
Nele Van Den Noortgate MD PhD15; Francesco Landi MD PhD24 
1. WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and 
Aging, Division of Public Health, Epidemiology and Health Economics, University of 
Liège, Liège, Belgium  
2. Rehabilitation Research Group, Hospital Del Mar Medical Research Institute 
(IMIM), Barcelona, Spain 
3. Department of Health Sciences, Universitat Pompeu Fabra, Barcelona, Spain 
4. Geriatrics Department. Parc Salut Mar, Barcelona, Spain 
5. University of Exeter Medical School, Exeter, United Kingdom 
6. Healthcare for Older People Department, Royal Devon & Exeter NHS Foundation 
Trust, Exeter, UK 
7. Faculty of Medicine. Department of Internal Medicine and Gerontology, Jagiellonian 
University, Krakow, Poland 
8. University Hospital, Krakow, Poland 
9. Geriatrics Department. CHU Brugmann, Université Libre de Bruxelles, Brussels, 
Belgium 
10. Department of Clinical Rehabilitation, University School of Physical Education, 
Krakow, Poland  
11. University Hospital, Krakow, Poland. 
12. Agaplesion Bethesda Clinic Ulm, Ulm, Germany 

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13. Boston University School of Public Health, Dept. Epidemiology, Boston, United 
States of America 
14. Department of Geriatrics, Ghent University Hospital, Ghent, Belgium 
15. Hospital of Slagelse. Region Sjaelland, Slagelse, Denmark 
16. Dana Hrnciarikova, MD, PhD, University Hospital Hradec Kralove, Czech Republic 
17. Physical Medicine and Rehabilitation Department, Parc de Salut, Barcelona, Spain 
18. School of Medicine, Universitat Autònoma de Barcelona, Spain 
19. Universitat Internacional de Catalunya, Barcelona, Spain 
20. Nova Medical School, Lisbon, Portugal 
21. Centro Hospitalar Lisboa Central, Hospital de Santa Marta, Portugal 
22. Third Faculty of Medicine, Charles University, Prague, Czech Republic 
23. Aging Research Center, Karolinska Institutet, Stockholm, Sweden 
24. Department of Geriatrics, Neurosciences and Orthopedics, Catholic University of 
the Sacred Heart, Rome, Italy 
 

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ABBREVIATIONS 
BMI: Body mass index 
CKD-epi: Chronic Kidney Disease Epidemiology collaboration 
COPD: Chronic obstructive pulmonary disease 
EAMA: European Academy for Medicine of Ageing 
EuGMS: European Union Geriatric Medicine Society 
EWGSOP: European Working Group on Sarcopenia in Older People  
EWGSOP2: Revised European Consensus on definition and diagnosis 
GLISTEN: Gruppo Lavoro Italiano Sarcopenia, Trattamento E Nutrizione 
IQR: Interquartile range 
MNA-SF: Mini-Nutritional assessment-Short form 
SD: Standard deviation 
SIG: Special Interest Group on Sarcopenia 
STROBE: Strengthening the Reporting of Observational Studies in Epidemiology 
Statement. 
 
 
 

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BACKGROUND 
Sarcopenia is a disease(1) characterized by progressive and generalized loss of 
skeletal muscle mass and strength, and is related to worse clinical outcomes, physical 
impairment(2), and mortality(3) in all healthcare settings(4). This nutrition-related 
didsease(5) is reversible and can be effectively counteracted by exercise and nutritional 
support(6)(7)(8)(9).  
The prevalence of sarcopenia varies widely depending on the criteria, methods, and 
cut-off points used for its assessment(10)(11). Although the European Working Group 
on Sarcopenia in Older People (EWGSOP) recommended assessing sarcopenia in 
geriatric patients in all care settings(4)(12), few studies addressing hospitalized older 
patients have been carried out, mainly due to the characteristics of acute healthcare 
settings and their in-patients(13)(14)(15)(16) and because the criteria used are difficult 
to carry out there. Therefore, this condition remains under-recognized in the setting 
where this disease(1) is likely to be more present(13)(14).   
Sarcopenia is expected to be a major healthcare problem in the upcoming years in 
Europe(17), so, in response to this claim for Public Health Action, the European Union 
Geriatric Medicine Society founded the Special Interest Group (SIG) on sarcopenia that 
has taken the lead of bridging the gaps between clinical and research(18) in sarcopenia 
field(18), in line with the Conference on Frailty and Sarcopenia Research Task 
Force(7), and the World Health Organization’s strategies to promote Optimal 
Aging(19). This goal of SIG on sarcopenia by EuGMS is being carried out by 
promotion of collaboration among International scientific societies and institutions; 
they have recently launched the Revised European consensus on definition and 
diagnosis (EWGSOP2)(4), the SARCUS project on ultrasound for sarcopenia 

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assessment in European countries(20)(21), and the first International Registry of 
patients with sarcopenia(22).  
The new goal, assumed by the SIG on Sarcopenia is to assess sarcopenia in acute 
healthcare settings across European countries. This challenging project has been 
developed involving The European Academy for Medicine of Ageing (EAMA) is a 
postdoctoral fellowship on behalf of the EuGMS formed by European specialists in 
Geriatric Medicine focused on improving networking, establishing specific fields of 
interest, and providing an opportunity for lifelong learning(23). The Sarcopenia 9+ 
EAMA project working group has assumed the goals stablished by SIG on Sarcopenia 
by EuGMS and is focused on sarcopenia in acute healthcare settings across European 
countries. 
Our study aims to provide an overview of sarcopenia assessment in hospitalized 
older patients across 9 European countries and has 5 objectives: 
1. To determine prevalence of sarcopenia among hospitalized patients in Europe.  
2. To determine incidence of sarcopenia during the hospital stay. 
3. To identify risk factors for the development of sarcopenia at the time of 
admission and during hospitalization (i.e. malnutrition as defined by the Global 
Leadership initiative on Malnutrition).  
4. To assess sarcopenia as a risk factor for clinical adverse outcomes during 
hospitalization (hospital-acquired infections, falls, delirium, longer length-of-
stay, disability, and mortality). 
5. To assess sarcopenia as a risk factor for clinical adverse outcomes post-
discharge (institutionalization, hospitalizations, falls, disability, and mortality) at 
3- and 12-month follow-up. 

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METHODS 
Design: Longitudinal, prospective, observational multicenter study in 
consecutive hospitalized patients in 9 European countries [Belgium, Czech Republic, 
Denmark, Germany, Italy, Poland, Portugal, Spain, and United Kingdom]. The 
guidelines of the Strengthening the Reporting of Observational Studies in Epidemiology 
(STROBE) Statement will be followed(24). No major changes to methods or eligibility 
criteria after study commencement are planned. 
Settings: Acute-care geriatric units. The description of the 9 settings involved in 
data collection has been stated in the affiliation section.  
Participants: Patients aged 70 years and older who are admitted to the acute 
care geriatric units will be included. This may include acute medical conditions or 
chronic disease decompensation; patients are eligible for referral to acute geriatric units 
due to medical diseases, such us urinary tract infections, respiratory tract infections, 
pneumonia, coronary heart diseases, atrial fibrillation, congestive heart failure, stroke, 
delirium, electrolyte disturbances, kidney disease, cancer, etc... Exclusion criteria: 
Length of stay less than 24 h expected, inability to perform hand-grip, hip or lower 
limbs fractures, amputations, terminally ill patients admitted for palliative care, and 
unwillingness to take part in the study.  
Main outcome measure: 1) Prevalence of sarcopenia at admission (± 48h). A 
prevalent case of sarcopenia will be considered if a patient fulfills the EWGSOP2 at 
admission; 2) Incidence of sarcopenia between admission and discharge (± 24h). A 
incident case of sarcopenia will be considered if a patient that do not fulfill EWGSOP2 
diagnostic criteria at admission, fulfills the diagnostic criteria at discharge (diagnosis 
will be considered as a dichotomous variable -yes/no-); 3) Risk factors involved in the 

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development of sarcopenia during hospitalization; 4) Clinical adverse outcomes related 
to sarcopenia (incidence of hospital-acquired infections, falls, delirium, length-of-stay, 
disability, 
and 
mortality); 
5) 
Clinical 
adverse 
outcomes 
post-discharge 
(institutionalization, hospital readmissions, falls, disability, and mortality) at 3- and 12-
month follow-up. 
Variables of sarcopenia (Table 1). SARC-F questionnaire will be administered 
for sarcopenia screening(25)(26): a score ≥4 (from a maximum of 10) will be 
considered as predictive of sarcopenia. EWGSOP2 criteria will be followed to 
determine the diagnosis of sarcopenia, considered as a dichotomous variable -yes/no- in 
presence of low grip strenght + low muscle mass + low gait speed for severity 
grading(4). Muscle strength will be measured by isometric handgrip dynamometry 
(hand-held dynamometer model JAMAR©] following standardized methods(27)(28); 
the corresponding cut-off points recommended by EWGSOP2 will be used (27 Kg en 
men and <16 in women)(27). Muscle mass will be assessed by calf circumference, 
considering a cut-off point of <31cm(27)(29). Gait speed will be measured by 4-m walk 
test(27)(30), where a cut-off point of 0.8m/s will be used(27)(31). Gait speed will be 
considered 0 m/s in bedridden patients unable to stand or in those unable to walk in 
safety conditions(13)(14)(32)(33).  
Other variables: Age, sex, comorbidity (Charlson index), functional status by 
instrumental (Lawton index)(34) and basic (Barthel index)(35) activities of daily living, 
medical conditions, and diagnosis at admission will be recorded. The Barthel index will 
be used to assess functional status one week before hospital admission (by clinical 
interview with patients and confirmed by caregivers, medical records, and general 
practitioner as appropriate), at admission, and at discharge(36)(37). Functional changes, 
calculated by subtracting the Barthel index at admission from the Barthel index at 

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discharge, will be recorded(37). Drugs will be recorded by the Anatomical Therapeutic 
Chemical (ATC) Classification System. Marital status living conditions, dependent on 
carers, years of education, level of pain (11-point pain intensity numerical rating scale, 
PI-NRS-)(38)(39), and level of usual physical activity by the Rapid Assessment of 
Physical Activity will be also recorded. Variables related to hospital admissions (time of 
admission and discharge), and number of hospitalizations during the last and previous 3 
months) will also be recorded. 
Nutritional assessment: The Global Leadership Initiative on Malnutrition 
(GLIM) criteria will be followed to diagnose malnutrition(8)(40). All in-patients will be 
screened for risk of malnutrition at admission by the Mini-Nutritional Assessment 
Short-Form (MNA-SF)(41); days of fasting, defined as the non-consumption of at least 
two main meals, will also be recorded. Body weight will be measured to the nearest 
0.1Kg; height will be measured in all patients able to stand in safety conditions, 
otherwise a knee-height equation(42) will be applied. Cognitive status will be assessed 
by Mini-Mental State Examination, Geriatric Depression scale (GDS15), as well as 
presence of delirium by the CAM. Frailty will be assessed by the FRAIL scale(43) and 
frailty phenotype(44). 
Biochemical values for total proteins, albumin, high (LDLc) and low-density 
lipoproteins cholesterol (HDLc), total cholesterol, triglycerides, apoB cholesterol, 
homocysteine-related markers (folic acid and B12 vitamin), vitamin D, glycosylate 
haemoglobin (Hb1C), iron profile (serum iron, transferring saturation, and ferritin), 
thyroid-stimulating hormone, electrolytes (sodium, potassium), renal profile [creatinine, 
urea, and glomerular filtration rate from the Chronic Kidney Disease Epidemiology 
Collaboration (CKD-epi)], hemoglobin, erythrocyte sedimentation rate test, albumin, 
and C-reactive protein will be obtained.  

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Procedure (Table 2). Patients will receive a comprehensive geriatric assessment 
by an interdisciplinary team and a care plan for their specific needs, as part of the usual 
care in acute wards at admission. Tests for the diagnosis of sarcopenia will be 
performed within 48h of hospital admission, and again at discharge (± 24h) by the 
interdisciplinary team involved in this study. Discharge will be defined as the moment 
when the patient leaves the acute care hospital independently of their destination, to 
ensure coherence among countries in despite of the different healthcare resources (home 
back to Primary care, hospital-at-home scheme, care home (residential or nursing), 
postacute, transitional or rehabilitation care, transferred to another acute ward); all 
patients will be discharged according to clinical criteria as part of usual care of the unit, 
independently of the diagnosis of sarcopenia. Sarcopenia (outcome measure variable) 
will be assessed using EWGSOP 2 criteria and recorded at admission and at discharge. 
SARC-F questionnaire will be administered at admission and at 3- and 12- month 
follow-up. Blood samples will be extracted at admission by a trained member (usually a 
nurse) of the interdisciplinary team.  
Hospital admission. Demographic data (age, date of birth, sex, marital status, 
living conditions, education level), administrative data (time of admission, number of 
previous hospital admissions in the last month and in the last 3 months), prevalent and 
incident medical conditions (Charlson index), diagnosis for hospital admission, 
hypertension assessment, medication use (Anatomical Therapeutic Chemical (ATC) 
Classification System, functional (Barthel index), nutritional (MNA-SF, weight, height, 
diagnosis of malnutrition as defined by GLIM), frailty (FRAIL and Frailty phenotype), 
and cognitive assessment (MMSE, GDS15, CAM), and pain (PI-NRS) will be collected 
within 48h of admission. Hospital discharge. Administrative data (time of discharge 
and place of discharge), medication use, weight, functional status, in-hospital adverse 

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outcomes (urinary and respiratory tract infections, falls, and delirium), presence of pain 
(PI-NRS), days of fasting and bed rest, hypertension and orthostatic hypotension 
assessment, and mortality will be addressed within 24h prior to hospital discharge. 
Follow-up. Administrative data (date of the follow-up, hospital re-admissions, and 
visits to the emergency department), SARC-F questionnaire), pain (PI-NRS), functional 
status (Barthel index), institutionalization, hospital readmissions, and mortality after 
discharge will be assessed and collected by telephone interview with the patient or 
caregiver or from medical records at 3-month and 12 month-follow-up. 
Chronogram and dynamics (Table 3): Email will be used for communications 
among the working group members. All the EAMA working groups have approved the 
study protocol. The approval of the Ethics Committees of all settings will be requested 
in all centers. Field work and data collection will start as soon each partner will 
obtained their respective Ethics Committee approval. Each partner will collect data 
during 4 months or the time needed to assess approximately 100 patients; however, 
every team may continue collecting data until the last team has finished the field work, 
if they choose to do so. A minimum of 50 patients should be collected by each partner, if 
possible, and no upper limit will be imposed. If one of the working group members is 
unable to complete the field work, collaboration in other tasks will remain an option. 
Data collection will be recorded in an Excel spreadsheet and analysed by the groups 
from Belgium, Germany, Italy, Spain, Poland, and United Kingdom.  
Sources of funding: No external funding is anticipated. Every member of the 
working will use their own human and technical resources to develop the different 
phases of the study. The working group may seek eventual sources of funding (ERC, 
ESPEN grant fellowship, Erasmus+ Teaching, National grants, Fondo Investigación en 

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Salud Carlos III in Spain…) depending on the results of the ongoing project in further 
stages.  
Statistical analysis: Descriptive analysis of the sample will use percentages and 
frequency distributions for categorical variables, and means with standard deviations 
(SD) or medians with interquartile ranges (IQR) for continuous variables. Univariate 
analysis will be used to check clinical and functional characteristics of the study 
participants according to the diagnosis of sarcopenia as defined by EWGSOP. 
Categorical variables will be compared by Chi-square or Fisher exact test, as 
appropriate, and continuous variables by Student t test. Univariate and multivariate 
analyses will be performed for all outcomes to examine possible associations with 
covariables. P values <0.05 will be considered as statistically significant. Statistical 
analysis will be performed using STATA 15.0 software (Stata Corp.; College Station, 
Texas, USA). 
Sample size determination: Sample size was calculated in terms of the 
Sarcopenia 9+ EAMA project objectives; a sample size of 369 patients randomly 
selected will suffice to estimate with a 95% confidence and a precision ±5 percent units, 
a prevalence of sarcopenia at admission considered to be around 40%. For the incidence 
of sarcopenia study, a sample size of 218 patients randomly selected will suffice to 
estimate with a 95% confidence and a precision ±5 percent units, a population 
percentage considered to be around 15%. It has been anticipated a replacement rate of 
10%; this relatively low percentage of loss reflects the expected adherence to usual care 
and follow-up of patients in a geriatric acute ward and a geriatric outpatient clinic for 
the duration of the study. Sample size calculation was performed using GRANMO 

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(Calculadora de Grandària Mostral GRANMO, version 7.12. Abril 2012, Institut 
Hospital del Mar d’Investigacions Mèdiques (IMIM), Barcelona, Spain)(45).  
Ethics: National and international research ethics guidelines will be 
followed(46), including the Deontological Code of Ethics, Declaration of Helsinki, and 
Spain’s confidentiality law concerning personal data (Ley Orgánica 15/1999, 13 
December, Protección de Datos de Carácter Personal). Detailed, understandable oral 
and written information will be provided to patients and family members (see file 
attached, Information file, including and in concordance with the General Data 
Protection Regulation (GDPR), informed consent to participate will be signed (see file 
attached, Informed consent). The study has been approved by Parc Salut Mar, Local 
Ethics Committee, Barcelona (CEIm - Parc Salut Mar, ref. number. 2018/8355/I), CHU 
Brugmann, Brussels (CE 2019/26), Krakow University Hospital, Krakow, and Centro 
Hospitalar Universitario de Lisboa, Lisbon (Processo n.°596/2018), and is currently 
submitted and pending of approval in the rest of centers. Data will be entered are treated 
in accordance with the provisions of the applicable data protection law in Spain and the 
General Data Protection Regulation (GDPR) (EU) nº 2016/679 of the European 
Parliament and Council, dated the 27 April of 2016, which entered into force last 25 
May 2018. 
Possible points for the discussion section 
This is a protocol for a study to determine the prevalence and incidence of 
sarcopenia, to assess the factors involved in its onset and its clinical adverse outcomes 
during hospitalization in acute care and post discharge in a 3 and 12-month follow-up in 
in Europe; no data are yet available. The overall purpose of our study and is to take a 

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pragmatic approach in assessing sarcopenia in clinical practice in Europe and provide 
insight to develop eventual therapeutic interventions.  
To date, few studies have addressed sarcopenia in hospitalized patients and no 
data are available across Europe. Following the model of the multicentre GLISTEN 
study, which assessed sarcopenia in acute geriatric care settings across Italy(13)(14), our 
survey will assess the prevalence, incidence, risk factors, and clinical outcomes of 
sarcopenia in hospitalized patients in 9 European countries. One of the limitations of 
our study will be the assessment of sarcopenia at discharge, mainly due to three issues.  
First, the status of patients at discharge depends on their evolution; therefore, 
discharge is not a unifying condition. For example, patients may be discharged home 
independently due to complete resolution of the acute process or discharged to a 
postacute care setting to recover functional status; some countries have very short 
hospital stays and as soon as the patient are stable, they are sent to other institutions for 
rehabilitation, others have longer length of stay and receive rehabilitation in the 
hospital. In order to address this methodological limitation, An additional regular point 
of assessment at the 7-10th b day of admission had been planned, but finally, the authors 
considered that it was difficult to be performed and added extra workload, so, it was 
deleted to the study protocol; further studies might be able to include this additional 
assessment point in those patients with an extended hospital stay. Second, although the 
concept of being discharged was defined to gain consistency on the definition and 
minimize differences due to healthcare resources, every country has different discharge 
procedures and the clinical criteria to discharge a patient from acute care still might 
differ from clinician to clinician and from country to country. Finally, the concept of 
“acute care units” or “institutionalization” also may differ by country, depending on 

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care assistance levels and the strategies of the respective national health systems across 
Europe.  
Another potential limitation of our study is the use of anthropometric measures 
to assess muscle mass, which is much more practical and widely applicable than 
alternative measures of muscle mass. Although acknowledged by the EWGSOP to 
assess muscle mass, its use might be controversial(29)(47) and could open a research 
line for further studies using other assessment tools. 
 
Some strengths of our study might be highlighted, and positive results are 
already anticipated, as an additional goal is to establish a stable European partnership on 
sarcopenia in order to develop further research projects and collaborations. Other aspect 
to be highlighted is that the study protocol includes the most important clinical adverse 
outcomes, such as mortality, hospitalization, institutionalization, falls, disability, and 
mortality.  
 
The initial Publication plan is promising and additionally from the main 
objectives, new topics on sarcopenia field are expected to be assessed, i.e. sarcopenia 
and frailty as nutrition-related conditions and their relationship with malnutrition as 
defined by GLIM criteria, a new, unified, international definition launched by the largest 
enteral and parenteral societies worldwide in October 2018, and which is pending of 
validation(8)(40). Other novel topics to be included in the Publication plan are the 
relationships between sarcopenia, hypertension, and orthostatic hypotension; and the 
relationship between sarcopenia and delirium, whose augmented risk when sarcopenia 
is present at admission was also recently assessed in the GLISTEN study(50).  
Collaborative partnerships and external proposals for use of data will be welcome and 
checked by the Sarcopenia 9+ EAMA working group before approval; those proposals 
admitted will be included in the Publication plan of this working group.  

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The desired outcome is the application of emerging research in clinical practice, 
following the “Action-Research Philosophy”(51), in order to improve care in patients 
with sarcopenia. Knowledge about the incidence of sarcopenia and its onset might shed 
light on its staging, in order to develop eventual therapeutic strategies.  
 
 
 

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