SARCOPEDIA - Sarcopenia Diagnostics in Aging Medicine

NCT05263596 | Recruiting

• 1 other identifier: 2021-01907
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Muscle Weakness; Frailty

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  12 months

Study Arms (3)

No Sarcopenia (Control Group)

OTHER

healthy participants

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))

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))

Diagnostic Test: dual x-ray absorptiometry, body impedance analysis, muscle strength measurements, ultrasound

Interventions

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

No Sarcopenia (Control Group); Sarcopenia is confirmed; Sarcopenia is probable

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• The investigators aim to include patients ≥ 65 years old newly admitted for study eligibility at the UAFP.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Department of Geriatric Medicine FELIX PLATTER: lead

Study Sites (1)

Universitäre Altersmedizin Felix Platter

Basel, 4002, Switzerland

RECRUITING

Related Publications (2)

• 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.

  PMID: 28286250 BACKGROUND

• 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.

  PMID: 30312372 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Muscle Weakness; Frailty

Interventions

Absorptiometry, Photon; Ultrasonography

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Andreas M. Fischer

  Universitäre Altersmedizin Felix Platter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas M. Fischer

CONTACT

0613265102; andreasmfischer.basel@gmail.com

Natalie N Godau

CONTACT

0613265102; andreasmfischer.basel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 2, 2022
• Study Start: July 11, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)