SarcopeniaEAMA9+NCT04039620
EAMA Sarcopenia in Acute Care Patients in 9+European Countries
An observational study of Sarcopenia and Malnutrition, run by Parc de Salut Mar at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia, Malnutrition
- How many people
- 366 participants
- Where
- 1 siteSpain
- Study dates
- 6 Mar 2019to 2 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older patients hospitalized in acute care units due to medical processes
Who may be able to join
- Patients aged >70 admitted to acute hospital medical units
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Sarcopenia, Malnutrition
- Being tested
- Observational study, no interventions expected
- Keywords
- Sarcopenia, Malnutrition, EWGSOP2, Older people, Acute care, Hospitalized
- Medical subject headings
- Sarcopenia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no interventions expectedOther
No interventions are planned
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sarcopenia as defined by the European consensus on definition and diagnosis (EWGSOP2)
Prevalence sarcopenia in acute hospitalized older patients.
Measured: One year (March 2019-March 2020)
Incidence of sarcopenia as defined by the European consensus on definition and diagnosis (EWGSOP2)
Incidence of sarcopenia in acute hospitalized older patients.
Measured: One year (March 2019-March 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start6 Mar 2019
- Primary completion2 Apr 2021
- Study completion2 Apr 2023
Why it stopped: COVID-19 pandemic and lack of funding necessary for continuation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University, Université Libre de Bruxelles, Agaplesion Bethesda Clinic Ulm, Ulm, Germany, Slagelse Hospital, Charles University, Czech Republic, NOVA Medical School, Karolinska Institutet, Catholic University of the Sacred Heart, University Hospital, Ghent, University of Exeter
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039620
- Sponsor's protocol ID
- 2018/8355/I
- Acronym
- EAMA9+
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2019
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31230903
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04039620
- Acronym / sponsor ID
- EAMA9+ / 2018/8355/I
- Conditions
- Sarcopenia, Malnutrition
- Keywords
- Sarcopenia, Malnutrition, EWGSOP2, Older people, Acute care, Hospitalized
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic and lack of funding necessary for continuation
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Jagiellonian University, Université Libre de Bruxelles, Agaplesion Bethesda Clinic Ulm, Ulm, Germany, Slagelse Hospital, Charles University, Czech Republic, NOVA Medical School, Karolinska Institutet, Catholic University of the Sacred Heart, University Hospital, Ghent, University of Exeter
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older patients hospitalized in acute care units due to medical processes
Key inclusion criteria (1 listed)
- Patients aged >70 admitted to acute hospital medical units
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, no interventions expectedNo interventions are planned | Other | – |
Primary outcome
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.
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.
Results and safety
The study was stopped early (reason given: COVID-19 pandemic and lack of funding necessary for continuation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Background: PubMed 31230903Sanchez-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.
- Sarcopenia in Acute Care Patients: Protocol for the European Collaboration of Geriatric Surveys: Sarcopenia 9+ EAMA Project.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Malnutrition, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic and lack of funding necessary for continuation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sarcopenia as defined by the European consensus on definition and diagnosis (EWGSOP2) (time frame: One year (March 2019-March 2020)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04039620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.