SARCOPEDIA - Sarcopenia Diagnostics in Aging Medicine (SARCOPEDIA)
Primary Purpose
Sarcopenia, Muscle Weakness, Frailty
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
The investigators aim to include patients ≥ 65 years old newly admitted for study eligibility at the UAFP.
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
No Sarcopenia (Control Group)
Sarcopenia is probable
Sarcopenia is confirmed
Arm Description
healthy participants
Low muscle strength (in accordance with the guidlines of "The European Working Group on Sarcopenia in Older People 2" (EWGSOP2))
Low muscle strength + low muscle quantity (in accordance with the guidlines of "The European Working Group on Sarcopenia in Older People 2" (EWGSOP2))
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05263596
First Posted
February 3, 2022
Last Updated
May 24, 2022
Sponsor
University Department of Geriatric Medicine FELIX PLATTER
1. Study Identification
Unique Protocol Identification Number
NCT05263596
Brief Title
SARCOPEDIA - Sarcopenia Diagnostics in Aging Medicine
Acronym
SARCOPEDIA
Official Title
SARCOPEDIA - Sarcopenia Diagnostics in Aging Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 11, 2022 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Department of Geriatric Medicine FELIX PLATTER
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Muscle Weakness, Frailty
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No Sarcopenia (Control Group)
Arm Type
Other
Arm Description
healthy participants
Arm Title
Sarcopenia is probable
Arm Type
Other
Arm Description
Low muscle strength (in accordance with the guidlines of "The European Working Group on Sarcopenia in Older People 2" (EWGSOP2))
Arm Title
Sarcopenia is confirmed
Arm Type
Other
Arm Description
Low muscle strength + low muscle quantity (in accordance with the guidlines of "The European Working Group on Sarcopenia in Older People 2" (EWGSOP2))
Intervention Type
Diagnostic Test
Intervention Name(s)
dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
No Sarcopenia (healthy participants) - according to the current European Working Group on Sarcopenia in Older People 2
Description
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
Time Frame
12 months
Title
Probable Sarcopenia - according to the current European Working Group on Sarcopenia in Older People 2
Description
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
Time Frame
12 months
Title
Confirmed Sarcopenia - according to the current European Working Group on Sarcopenia in Older People 2
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The investigators aim to include patients ≥ 65 years old newly admitted for study eligibility at the UAFP.
Exclusion Criteria:
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
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
28286250
Citation
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.
Results Reference
background
PubMed Identifier
30312372
Citation
Cruz-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. Erratum In: Age Ageing. 2019 Jul 1;48(4):601.
Results Reference
background
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SARCOPEDIA - Sarcopenia Diagnostics in Aging Medicine
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