SarcopeniaNCT02664376
Prevalence of Sarcopenia and Its Geriatric Features
An observational study of Sarcopenia, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
The goal of this study is to determine the prevalence of sarcopenia in a geriatric hospital ward. Sarcopenia is defined by a loss of muscle mass, loss of muscle strength and loss of muscle quality. It is a geriatric syndrome that, to this date, is not systematically tracked in clinical practice. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Sarcopenia detection
- How many people
- 834 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2016to 18 Jan 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Each patient over 65 years admitted to the unit 83 of the Geriatric Department, CHU Brugmann Hospital, from 10/01/2016 till 30/03/2017 undergoes a comprehensive geriatric assessment at the end of its hospitalisation stay. The screening for sarcopenia is part of this geriatric assessment.
Who may be able to join
- To be admitted in the unit 83 of the Geriatric Departement of the CHU Brugmann hospital, from 10/01/2016 till 30/03/2017.
Who cannot join
- Patients unable to consent or without representatives
- Patients unable to perform the hand- grip test, the walk test or measurement of the body components by DEXA
- Patients in severe pain
- Bedridden patients
- Patients for which a clear therapeutic abstention has been established
- Language barriere that cannot be overcome
- Patients unable to walk without the help of a third person
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to determine the prevalence of sarcopenia in a geriatric hospital ward.
Sarcopenia is defined by a loss of muscle mass, loss of muscle strength and loss of muscle quality. It is a geriatric syndrome that, to this date, is not systematically tracked in clinical practice.
In order to detect sarcopenia, the investigators will use the operational definition proposed by the European Working Group (EWGSOP) involving the measure of three parameters, namely the speed of walking, the muscle strength and the measurement of the muscular mass.
- Conditions
- Sarcopenia
- Being tested
- Sarcopenia detection
- Keywords
- sarcopenia, geriatry
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcopenia detectionOther
The assessment of sarcopenia is performed according to the recommendations of the EWGSOP (European Working Group on Sarcopenia in Older people). Three measurements are made:
- Muscle mass measurement by dual energy X-ray absorptiometry (DEXA).
- Walking speed measurement
- Hand grip test
A diagnosis of sarcopenia is established if the walking speed is inferior to 0.8 m/sec, the muscular strength is low and the muscular mass is low.
Data regarding the geriatric characteristics of this sarcopenic population will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric ward population | Every patient aged over 65 admitted in the unit 83 of the Geriatry Department, CHU Brugmann Hospital, undergoes a global geriatric evaluation at the end of its hospitalisation stay, including sarcopenia detection. Receives: Other: Sarcopenia detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sarcopenia
Sarcopenia detection will be performed at the end of each hospitalization stay in unit 83 of the CHU Brugmann Hospital (Geriatry Department)
Measured: From 10/01/2016 till 30/03/2017 (up to 15 months)
Secondary outcomes (1)
Percentage of hospitalized patients unable to perform the sarcopenia detection test
Systematic retrospective review of patients hospitalised in the geriatric ward of the CHU Brugmann hospital during the length of the study, in order to determine the percentage of patients that could not, because of one of more exclusion criteria, perform the sarcopenia detection test.
Measured: From 10/01/2016 till 30/03/2017 (up to 15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study start1 Jan 2016
- Primary completion18 Jan 2018
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murielle Surquin, Brugmann University Hospital
- Investigators
- Robin Barré, MD, Principal investigator, CHU BrugmannMurielle Surquin, MD, Principal investigator, CHU BrugmannFlorence Benoît, MD, Principal investigator, CHU BrugmannMarie Claessens, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664376
- Sponsor's protocol ID
- CHUB-sarcopenia
- Status last verified
- Jan 2018
- First submitted
- 19 Jan 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Baumgartner RN, Koehler KM, Gallagher D, Romero L, Heymsfield SB, Ross RR, Garry PJ, Lindeman RD. Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidemiol. 1998 Apr 15;147(8):755-63. doi: 10.1093/oxfordjournals.aje.a009520.
PubMed 9554417Cesari M, Kritchevsky SB, Newman AB, Simonsick EM, Harris TB, Penninx BW, Brach JS, Tylavsky FA, Satterfield S, Bauer DC, Rubin SM, Visser M, Pahor M; Health, Aging and Body Composition Study. Added value of physical performance measures in predicting adverse health-related events: results from the Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009 Feb;57(2):251-9. doi: 10.1111/j.1532-5415.2008.02126.x.
PubMed 19207142Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.
PubMed 14555665
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sarcopenia and Its Geriatric Features
- ClinicalTrials.gov ID
- NCT02664376
- Acronym / sponsor ID
- CHUB-sarcopenia
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, geriatry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 27 Jan 2016 (estimated)
- 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.
The goal of this study is to determine the prevalence of sarcopenia in a geriatric hospital ward.
Sarcopenia is defined by a loss of muscle mass, loss of muscle strength and loss of muscle quality. It is a geriatric syndrome that, to this date, is not systematically tracked in clinical practice.
In order to detect sarcopenia, the investigators will use the operational definition proposed by the European Working Group (EWGSOP) involving the measure of three parameters, namely the speed of walking, the muscle strength and the measurement of the muscular mass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric ward population | – | Other: Sarcopenia detectionEvery patient aged over 65 admitted in the unit 83 of the Geriatry Department, CHU Brugmann Hospital, undergoes a global geriatric evaluation at the end of its hospitalisation stay, including sarcopenia detection. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Each patient over 65 years admitted to the unit 83 of the Geriatric Department, CHU Brugmann Hospital, from 10/01/2016 till 30/03/2017 undergoes a comprehensive geriatric assessment at the end of its hospitalisation stay. The screening for sarcopenia is part of this geriatric assessment.
Key inclusion criteria (1 listed)
- To be admitted in the unit 83 of the Geriatric Departement of the CHU Brugmann hospital, from 10/01/2016 till 30/03/2017.
Key exclusion criteria (7 listed)
- Patients unable to consent or without representatives
- Patients unable to perform the hand- grip test, the walk test or measurement of the body components by DEXA
- Patients in severe pain
- Bedridden patients
- Patients for which a clear therapeutic abstention has been established
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 |
|---|---|---|
| Sarcopenia detectionThe assessment of sarcopenia is performed according to the recommendations of the EWGSOP (European Working Group on Sarcopenia in Older people). Three measurements are made: * Muscle mass measurement by dual energy X-ray absorptiometry (DEXA). * Walking speed measurement * Hand grip test A diagnosis of sarcopenia is established if the walking speed is inferior to 0.8 m/sec, the muscular strength is low and the muscular mass is low. Data regarding the geriatric characteristics of this sarcopenic population will be collected. | Other | Geriatric ward population |
Primary outcome
Prevalence of sarcopenia
Time frame: From 10/01/2016 till 30/03/2017 (up to 15 months)
Sarcopenia detection will be performed at the end of each hospitalization stay in unit 83 of the CHU Brugmann Hospital (Geriatry Department)
1 secondary outcome
Percentage of hospitalized patients unable to perform the sarcopenia detection test
Time frame: From 10/01/2016 till 30/03/2017 (up to 15 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Background: PubMed 9554417Baumgartner RN, Koehler KM, Gallagher D, Romero L, Heymsfield SB, Ross RR, Garry PJ, Lindeman RD. Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidemiol. 1998 Apr 15;147(8):755-63. doi: 10.1093/oxfordjournals.aje.a009520.
- Background: PubMed 19207142Cesari M, Kritchevsky SB, Newman AB, Simonsick EM, Harris TB, Penninx BW, Brach JS, Tylavsky FA, Satterfield S, Bauer DC, Rubin SM, Visser M, Pahor M; Health, Aging and Body Composition Study. Added value of physical performance measures in predicting adverse health-related events: results from the Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009 Feb;57(2):251-9. doi: 10.1111/j.1532-5415.2008.02126.x.
- Background: PubMed 14555665Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.
- 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.
Robin Barré, MD principal investigator
CHU Brugmann
Murielle Surquin, MD principal investigator
CHU Brugmann
Florence Benoît, MD principal investigator
CHU Brugmann
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, run by Brugmann University Hospital at 1 site in Belgium.
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 7 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: finished, as of the sponsor's last update on 26 Jan 2018. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: From 10/01/2016 till 30/03/2017 (up to 15 months)). 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 NCT02664376, which also lists 4 linked publications.
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 26 Jan 2018.