SARCOPEDIA - Sarcopenia Diagnostics in Aging Medicine

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity Department of Geriatric Medicine FELIX PLATTER

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Lack of informed written consent

Implanted defibrillation device

Implanted pacemaker

Acute sepsis or severe volume overload

Trial design

Design model

Crossover

Treatments tested in this trial

  • dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound

    Diagnostic 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

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: No Sarcopenia (Control Group)Other 1 intervention
Group B: Sarcopenia is probableOther 1 intervention
Group C: Sarcopenia is confirmedOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months
3

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

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.