SarcopeniaSARCOPEDIANCT05263596
SARCOPEDIA - Sarcopenia Diagnostics in Aging Medicine
A study testing dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound in people with Sarcopenia and Muscle Weakness, run by University Department of Geriatric Medicine FELIX PLATTER at 1 site in Switzerland.
Trial summary
Musculoskeletal aging is one of the major responsibilities and challenges for public health. In particular, sarcopenia correlates with an increased risk of falls and increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Muscle Weakness, Frailty
- What is being tested?
- dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jul 2022to 30 Oct 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- The investigators aim to include patients ≥ 65 years old newly admitted for study eligibility at the UAFP.
Who cannot join
- Lack of informed written consent
- Implanted defibrillation device
- Implanted pacemaker
- Acute sepsis or severe volume overload
- Life expectancy of < 3 months according to treating doctor
- bedridden
Show all 10Show fewer
- Plasters or bandages that cannot be removed from the feet or hands
- Isolated patients (contact and aerosol)
- Measurement is not possible due to organizational reasons
- Inability to follow the procedures, e.g. due to language problems, psychological disorders
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Universitäre Altersmedizin Felix Platter
Basel, 4002
Andreas M. Fischer, PD, +41613265102, AndreasM.Fischer@felixplatter.ch
About this study
Musculoskeletal aging is one of the major responsibilities and challenges for public health. In particular, sarcopenia correlates with an increased risk of falls and increased morbidity and mortality. With regard to screening for sarcopenia, the guidelines of the European Working Group on Sarcopenia in Older People (EWGSOP2) refer to algorithmic case finding, diagnosis, and quantification of the severity of sarcopenia in clinical. While functional measurements are more difficult to standardize and associated with higher variability, Dual-energy X-ray absorptiometry (DXA) is considered a highly accurate method, even referred to as the "gold standard" to determine muscle mass in the scientific literature. Nevertheless, DXA, which is routinely used, shows inconsistent correlation with functional decline in muscle strength. Another method of muscle quantification is bioelectrical impedance analysis (BIA), a simple, portable instrument that is more readily available and applicable due to its lower cost. However, it tends to overestimate muscle mass and is also more susceptible to a person's hydration status. Because of these difficulties, recent research has focused on the potential of using shear wave elastography. This method indirectly serves to quantify the rapid type II muscle fibers in order to make statements about the muscle quality because an age-related decrease in type II muscle fibers is associated with a more frequent fall frequency.
First, the investigators will define three different categories according to the EWGSOP 2 guidelines based on the muscle strength (grip strength, assessed by pneumatic hand dynamometer) and muscle mass (Appendicular skeletal muscle mass, assessed by BIA): "No Sarcopenia", "Probable Sarcopenia" and "Confirmed Sarcopenia". Within these categories, the Investigators would like to establish a multivariate data analysis of different functional measurements with quantitative imaging results. This exploratory trial design is intended to improve understanding within the three categories and to test proxy measurements of different patients who are ruled out for common routine measurements due to, for example, cognitive impairment or pre-existing rheumatic disease. This is essential to consider the heterogeneity of the aging society proportionally.
Read the detailed description
Once written informed consent is available, the following data are extracted from the patient's medical records: age and gender, number of medications and number of pre-existing chronic conditions, statin therapy (binary evaluation yes/ no), the laboratory values for CRP, prealbumin, cholinesterase, GFR and CK, and results from geriatric assessment routinely performed by a physiotherapist at admission or a resident physician: Mini Mental State Exam (MMSE), Clock-drawing test (CDT), Geriatric depression scale (GDS), Functional independence measure at admission (FIM) assessed by nurses or physiotherapist. Hand grip strength (HGS), Timed up and go Test (TUG) and Gait speed at admission assessed by physiotherapists; Nutritional risk screening (NRS) assessed by a nutritionist.
To complete baseline data, calf and mid-arm circumference will be measured. Meanwhile, the frailty of the participant is estimated by using the CFS.
For evaluation of muscle mass, body impedance analysis (BIA) is performed in all included patients using a BIVA 101® (Akern, SMT medical GmbH, Würzburg, Germany) within the first 6 days of hospitalization. To conduct this measurement, the patients lie in supine position with extremities stretched, not touching their core and not moving during the measurement. The measurement itself takes only a few seconds. Altogether, the measurements including the preparation phase will be performed within 10 to 15 minutes. As a potential bias, the hydration status of a patient can impair reliability of BIA results. Therefore, all measurements will take part at least 2 hours after the last meal in order to minimize possible fluctuations. If a patient suffers from an altered hydration status at admission (either clinically dehydrated or volume overloaded), the patient will be re-evaluated three days later and BIA measurement will be done if the patient is euvolemic at that time. Concerning those patients receiving continuous enteral feeding, BIA measurement will be performed only if <150 ml/h were delivered in the preceding 2 hours.
For further assessment of muscle mass, non-invasive DXA provides the total body Skeletal Muscle Mass (SMM) and the Appendicular Skeletal Muscle Mass (ASM). For these examinations, the patient cannot stay at her/ his room and will be transferred to an examination room. There an experienced physician will be present if needed for medical assistance before, during or after measurements. The device used for this study is the iDXA densitometer (GE Healthcare, Madison, WI, USA). Here, the study participant moves to an examination couch. The instrument, which is located opposite the examination couch, has an open design and can be viewed from all sides. A narrow scanner runs over the body at a distance of about 20 cm. The examination itself takes about 5 minutes while the patient remains relaxed and calm, breathing normally. In principle, muscle mass is correlated with body size, i.e. persons with a larger body size usually have a larger muscle mass. Therefore, when quantifying muscle mass, the absolute level of SMM or ASM can be adjusted for body size in several ways, namely by using height squared (ASM/height2), weight (ASM/weight), or body mass index (ASM/BMI), all of which are included in the assessment. As a definition of sarcopenia, cut-off points from EWGSOP2 will be used. All precision scans are performed by the same radiologic technologist under the supervision of the project manager.
A subsequent ultrasound examination (Philips PureWave EPIQ 5G, Amsterdam, Netherlands) will be used to detect the elasticity via elastography of two muscles in defined positions. The measurements positions are the Musculus (M.) quadriceps femoris in a supine position on an examination couch and the M. biceps brachii in an elbow flexed position at 90° with the forearm rested on the body. The probe will be placed on top of the skin with a minimal load ensuring no external pressure could affect the measurements. The elastography will be recorded in kilopascals (kPa). The examination, which takes about 5 minutes is also completely painless, and will be performed by the project leader.
The CST is then performed under the supervision and guidance of the examining physician. This clinical test is also used to assess mobility and is estimated to take approximately 3 minutes.
- Conditions
- Sarcopenia, Muscle Weakness, Frailty
- Being tested
- dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound
- Medical subject headings
- Sarcopenia, Muscle Weakness, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasoundDiagnostic test
Results from the routine geriatric assessment:
- Mini Mental State Exam (MMSE)
- Clock-drawing test (CDT)
- Geriatric depression scale (GDS)
- Functional independence measure (FIM) at admission
- Timed up and go Test (TUG)
- Gait speed
- Hand grip strength (HGS)
- Nutritional risk screening (NRS)
Additional measurements:
- Chair-stand-test
- Clinical frailty scale (CFS)
- Calf circumference and mid-arm circumference
- Body impedance analysis (BIA)
- US
- DXA
| Study group | Role | What they receive |
|---|---|---|
| No Sarcopenia (Control Group) | Other | healthy participants Receives: Diagnostic Test: dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound |
| Sarcopenia is probable | Other | Low muscle strength (in accordance with the guidlines of "The European Working Group on Sarcopenia in Older People 2" (EWGSOP2)) Receives: Diagnostic Test: dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound |
| Sarcopenia is confirmed | Other | Low muscle strength + low muscle quantity (in accordance with the guidlines of "The European Working Group on Sarcopenia in Older People 2" (EWGSOP2)) Receives: Diagnostic Test: dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
No Sarcopenia (healthy participants) - according to the current European Working Group on Sarcopenia in Older People 2
Normal muscle strength and normal size of muscle masss according to the current European Working Group on Sarcopenia in Older People 2. Grip strength is measured on the dominant hand by a pneumatic hand dynamometer (Martin Vigorimeter) in kPa. Healthy women: ≥ 27 kPa; healthy men: ≥ 45 kPa. Appendicular skeletal muscle mass (ASMM) is measured by the Body Impedance Analysis (BIA 101 Akern, Florence, Italy). Cut-off points for low appendicular skeletal muscle mass index (ASMI), calculated from ASMM/height2, were <7 kg/m2 for men and <5.5 kg/m2 for women
Measured: 12 months
Probable Sarcopenia - according to the current European Working Group on Sarcopenia in Older People 2
Low muscle strength and normal size of muscle mass according to the current European Working Group on Sarcopenia in Older People 2. Grip strength is measured on the dominant hand by a pneumatic hand dynamometer (Martin Vigorimeter) in kPa. Low muscle strength women: < 27 kPa; low muscle strength men: < 45 kPa. Appendicular skeletal muscle mass (ASMM) is measured by the Body Impedance Analysis (BIA 101 Akern, Florence, Italy). Cut-off points for low appendicular skeletal muscle mass index (ASMI), calculated from ASMM/height2, were <7 kg/m2 for men and <5.5 kg/m2 for women
Measured: 12 months
Confirmed Sarcopenia - according to the current European Working Group on Sarcopenia in Older People 2
Low muscle strength and low muscle mass according to the current European Working Group on Sarcopenia in Older People 2. Grip strength is measured on the dominant hand by a pneumatic hand dynamometer (Martin Vigorimeter) in kPa. Low muscle strength women: < 27 kPa; low muscle strength men: < 45 kPa. Appendicular skeletal muscle mass (ASMM) is measured by the Body Impedance Analysis (BIA 101 Akern, Florence, Italy). Cut-off points for low appendicular skeletal muscle mass index (ASMI), calculated from ASMM/height2, were <7 kg/m2 for men and <5.5 kg/m2 for women
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start11 Jul 2022
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas M. Fischer, Principal investigator, Universitäre Altersmedizin Felix Platter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263596
- Sponsor's protocol ID
- 2021-01907
- Acronym
- SARCOPEDIA
- Status last verified
- Jul 2024
- First submitted
- 3 Feb 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Van Ancum JM, Scheerman K, Jonkman NH, Smeenk HE, Kruizinga RC, Meskers CGM, Maier AB. Change in muscle strength and muscle mass in older hospitalized patients: A systematic review and meta-analysis. Exp Gerontol. 2017 Jun;92:34-41. doi: 10.1016/j.exger.2017.03.006. Epub 2017 Mar 10.
PubMed 28286250Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARCOPEDIA - Sarcopenia Diagnostics in Aging Medicine
- ClinicalTrials.gov ID
- NCT05263596
- Acronym / sponsor ID
- SARCOPEDIA / 2021-01907
- Conditions
- Sarcopenia, Muscle Weakness, Frailty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTERUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 2 Mar 2022 (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.
Musculoskeletal aging is one of the major responsibilities and challenges for public health. In particular, sarcopenia correlates with an increased risk of falls and increased morbidity and mortality. With regard to screening for sarcopenia, the guidelines of the European Working Group on Sarcopenia in Older People (EWGSOP2) refer to algorithmic case finding, diagnosis, and quantification of the severity of sarcopenia in clinical. While functional measurements are more difficult to standardize and associated with higher variability, Dual-energy X-ray absorptiometry (DXA) is considered a highly accurate method, even referred to as the "gold standard" to determine muscle mass in the scientific literature. Nevertheless, DXA, which is routinely used, shows inconsistent correlation with functional decline in muscle strength. Another method of muscle quantification is bioelectrical impedance analysis (BIA), a simple, portable instrument that is more readily available and applicable due to its lower cost. However, it tends to overestimate muscle mass and is also more susceptible to a person's hydration status. Because of these difficulties, recent research has focused on the potential of using shear wave elastography. This method indirectly serves to quantify the rapid type II muscle fibers in order to make statements about the muscle quality because an age-related decrease in type II muscle fibers is associated with a more frequent fall frequency.
First, the investigators will define three different categories according to the EWGSOP 2 guidelines based on the muscle strength (grip strength, assessed by pneumatic hand dynamometer) and muscle mass (Appendicular skeletal muscle mass, assessed by BIA): "No Sarcopenia", "Probable Sarcopenia" and "Confirmed Sarcopenia". Within these categories, the Investigators would like to establish a multivariate data analysis of different functional measurements with quantitative imaging results. This exploratory trial design is intended to improve understanding within the three categories and to test proxy measurements of different patients who are ruled out for common routine measurements due to, for example, cognitive impairment or pre-existing rheumatic disease. This is essential to consider the heterogeneity of the aging society proportionally.
Detailed description
Once written informed consent is available, the following data are extracted from the patient's medical records: age and gender, number of medications and number of pre-existing chronic conditions, statin therapy (binary evaluation yes/ no), the laboratory values for CRP, prealbumin, cholinesterase, GFR and CK, and results from geriatric assessment routinely performed by a physiotherapist at admission or a resident physician: Mini Mental State Exam (MMSE), Clock-drawing test (CDT), Geriatric depression scale (GDS), Functional independence measure at admission (FIM) assessed by nurses or physiotherapist. Hand grip strength (HGS), Timed up and go Test (TUG) and Gait speed at admission assessed by physiotherapists; Nutritional risk screening (NRS) assessed by a nutritionist.
To complete baseline data, calf and mid-arm circumference will be measured. Meanwhile, the frailty of the participant is estimated by using the CFS.
For evaluation of muscle mass, body impedance analysis (BIA) is performed in all included patients using a BIVA 101® (Akern, SMT medical GmbH, Würzburg, Germany) within the first 6 days of hospitalization. To conduct this measurement, the patients lie in supine position with extremities stretched, not touching their core and not moving during the measurement. The measurement itself takes only a few seconds. Altogether, the measurements including the preparation phase will be performed within 10 to 15 minutes. As a potential bias, the hydration status of a patient can impair reliability of BIA results. Therefore, all measurements will take part at least 2 hours after the last meal in order to minimize possible fluctuations. If a patient suffers from an altered hydration status at admission (either clinically dehydrated or volume overloaded), the patient will be re-evaluated three days later and BIA measurement will be done if the patient is euvolemic at that time. Concerning those patients receiving continuous enteral feeding, BIA measurement will be performed only if <150 ml/h were delivered in the preceding 2 hours.
For further assessment of muscle mass, non-invasive DXA provides the total body Skeletal Muscle Mass (SMM) and the Appendicular Skeletal Muscle Mass (ASM). For these examinations, the patient cannot stay at her/ his room and will be transferred to an examination room. There an experienced physician will be present if needed for medical assistance before, during or after measurements. The device used for this study is the iDXA densitometer (GE Healthcare, Madison, WI, USA). Here, the study participant moves to an examination couch. The instrument, which is located opposite the examination couch, has an open design and can be viewed from all sides. A narrow scanner runs over the body at a distance of about 20 cm. The examination itself takes about 5 minutes while the patient remains relaxed and calm, breathing normally. In principle, muscle mass is correlated with body size, i.e. persons with a larger body size usually have a larger muscle mass. Therefore, when quantifying muscle mass, the absolute level of SMM or ASM can be adjusted for body size in several ways, namely by using height squared (ASM/height2), weight (ASM/weight), or body mass index (ASM/BMI), all of which are included in the assessment. As a definition of sarcopenia, cut-off points from EWGSOP2 will be used. All precision scans are performed by the same radiologic technologist under the supervision of the project manager.
A subsequent ultrasound examination (Philips PureWave EPIQ 5G, Amsterdam, Netherlands) will be used to detect the elasticity via elastography of two muscles in defined positions. The measurements positions are the Musculus (M.) quadriceps femoris in a supine position on an examination couch and the M. biceps brachii in an elbow flexed position at 90° with the forearm rested on the body. The probe will be placed on top of the skin with a minimal load ensuring no external pressure could affect the measurements. The elastography will be recorded in kilopascals (kPa). The examination, which takes about 5 minutes is also completely painless, and will be performed by the project leader.
The CST is then performed under the supervision and guidance of the examining physician. This clinical test is also used to assess mobility and is estimated to take approximately 3 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Sarcopenia (Control Group) | Other | Diagnostic Test: dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasoundhealthy participants |
| Sarcopenia is probable | Other | Diagnostic Test: dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasoundLow muscle strength (in accordance with the guidlines of "The European Working Group on Sarcopenia in Older People 2" (EWGSOP2)) |
| Sarcopenia is confirmed | Other | Diagnostic Test: dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasoundLow muscle strength + low muscle quantity (in accordance with the guidlines of "The European Working Group on Sarcopenia in Older People 2" (EWGSOP2)) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- The investigators aim to include patients ≥ 65 years old newly admitted for study eligibility at the UAFP.
Key exclusion criteria (10 listed)
- Lack of informed written consent
- Implanted defibrillation device
- Implanted pacemaker
- Acute sepsis or severe volume overload
- Life expectancy of < 3 months according to treating doctor
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 |
|---|---|---|
| dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasoundResults from the routine geriatric assessment: * Mini Mental State Exam (MMSE) * Clock-drawing test (CDT) * Geriatric depression scale (GDS) * Functional independence measure (FIM) at admission * Timed up and go Test (TUG) * Gait speed * Hand grip strength (HGS) * Nutritional risk screening (NRS) Additional measurements: * Chair-stand-test * Clinical frailty scale (CFS) * Calf circumference and mid-arm circumference * Body impedance analysis (BIA) * US * DXA | Diagnostic test | No Sarcopenia (Control Group), Sarcopenia is confirmed, Sarcopenia is probable |
Primary outcome
No Sarcopenia (healthy participants) - according to the current European Working Group on Sarcopenia in Older People 2
Time frame: 12 months
Normal muscle strength and normal size of muscle masss according to the current European Working Group on Sarcopenia in Older People 2. Grip strength is measured on the dominant hand by a pneumatic hand dynamometer (Martin Vigorimeter) in kPa. Healthy women: ≥ 27 kPa; healthy men: ≥ 45 kPa. Appendicular skeletal muscle mass (ASMM) is measured by the Body Impedance Analysis (BIA 101 Akern, Florence, Italy). Cut-off points for low appendicular skeletal muscle mass index (ASMI), calculated from ASMM/height2, were <7 kg/m2 for men and <5.5 kg/m2 for women
Probable Sarcopenia - according to the current European Working Group on Sarcopenia in Older People 2
Time frame: 12 months
Low muscle strength and normal size of muscle mass according to the current European Working Group on Sarcopenia in Older People 2. Grip strength is measured on the dominant hand by a pneumatic hand dynamometer (Martin Vigorimeter) in kPa. Low muscle strength women: < 27 kPa; low muscle strength men: < 45 kPa. Appendicular skeletal muscle mass (ASMM) is measured by the Body Impedance Analysis (BIA 101 Akern, Florence, Italy). Cut-off points for low appendicular skeletal muscle mass index (ASMI), calculated from ASMM/height2, were <7 kg/m2 for men and <5.5 kg/m2 for women
Confirmed Sarcopenia - according to the current European Working Group on Sarcopenia in Older People 2
Time frame: 12 months
Low muscle strength and low muscle mass according to the current European Working Group on Sarcopenia in Older People 2. Grip strength is measured on the dominant hand by a pneumatic hand dynamometer (Martin Vigorimeter) in kPa. Low muscle strength women: < 27 kPa; low muscle strength men: < 45 kPa. Appendicular skeletal muscle mass (ASMM) is measured by the Body Impedance Analysis (BIA 101 Akern, Florence, Italy). Cut-off points for low appendicular skeletal muscle mass index (ASMI), calculated from ASMM/height2, were <7 kg/m2 for men and <5.5 kg/m2 for women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Background: PubMed 28286250Van Ancum JM, Scheerman K, Jonkman NH, Smeenk HE, Kruizinga RC, Meskers CGM, Maier AB. Change in muscle strength and muscle mass in older hospitalized patients: A systematic review and meta-analysis. Exp Gerontol. 2017 Jun;92:34-41. doi: 10.1016/j.exger.2017.03.006. Epub 2017 Mar 10.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
Andreas M. Fischer principal investigator
Universitäre Altersmedizin Felix Platter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound in people with Sarcopenia and Muscle Weakness, run by University Department of Geriatric Medicine FELIX PLATTER at 1 site in Switzerland.
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 10 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: status not confirmed, as of the sponsor's last update on 18 Jul 2024. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas M. Fischer (0613265102 ext. +41, andreasmfischer.basel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No Sarcopenia (healthy participants) - according to the current European Working Group on Sarcopenia in Older People 2 (time frame: 12 months). The study lists 3 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 NCT05263596, which also lists 2 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 18 Jul 2024.