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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
University Department of Geriatric Medicine FELIX PLATTER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 3, 2022
    Last Updated
    May 24, 2022
    Sponsor
    University Department of Geriatric Medicine FELIX PLATTER
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    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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