Biomarkers of Sarcopenia and Frailty in Geriatric Patients

NCT05795556 | Completed

• 1 other identifier: H-20057620
• Study Type: observational
• Target: 508
• Locations: 1 country
• Sites: 1

Brief Summary

During the last decades there has been an increase in the relative proportion and life expectancy of elderly people. Hence, the number of elderly with diseases and disabilities related to aging will increase and consequently, age-related losses in skeletal muscle mass and physical function represents an important current and future public health issue. Sarcopenia is a progressive and generalized skeletal muscle disorder that is considered central to the development of physical deconditioning and untreated sarcopenia is linked to falls, morbidity, and mortality. The underlying mechanisms behind the progressive loss of muscle mass and function associated with aging are yet unknown but seems to be multifactorial. A decrease in physical activity level and an altered central and peripheral nervous system innervation have been identified as some of the contributing factors. Furthermore, chronic low-grade inflammation has been proposed as a central contributor to sarcopenia and thus physical frailty. However, it is not yet clear whether the elevated markers of inflammation seen in the elderly are due to aging, chronic illness, or inactivity. But overall, it seems that inflammation plays an important role in the development of muscle loss, and is related to increased risk of falls, fragility, and early death.

Conditions

Sarcopenia; Muscle Loss; Fall Patients

Outcome Measures

Primary Outcomes (3)

• Skeletal muscle mass

  Determination of skeletal muscle mass measured by Bioelectrical Impedance analysis (BIA Inbody770)

  Baseline

• Appendicular lean muscle mass

  Determination of appendicular lean muscle mass (The sum of the lean tissue is the arms and legs) measured by Bioelectrical Impedance analysis (BIA Inbody770)

  Baseline

• Skeletal muscle mass index (SMI)

  Determination of skeletal muscle mass index (The sum of the lean tissue is the arms and legs scaled to height squared (ALM/height(2)) measured by Bioelectrical Impedance analysis (BIA Inbody770)

  Baseline

Secondary Outcomes (9)

• Muscle Thickness

  Baseline

• Muscle strength (upper body)

  Baseline

• Muscle strength (lower body)

  Baseline

• Physical Activity (Chair rise)

  Baseline

• Physical Activity (Gait speed)

  Baseline

Study Arms (1)

Home-dwelling geriatric outpatients

Home-dwelling geriatric outpatients from the Falls Clinic at Gentofte Hospital . Clinical assesment: Blood test, body composition (BIA and/or DXA), balance tests (sway), handgrip strength, isometric knee extension strength, chair-rise test, gait-speed, thickness of the thigh muscles, screening for sarcopenia (SARC-F), screening for malnutrition (SNAQ), screening for depression (GDS-15), screening for self-rated health (EQ-5D-5L), frailty (CSHA Frailty Scale)

Other: Assessing sarcopenia and potential biomarkers of sarcopenia in fall patients

Interventions

Assessing sarcopenia and potential biomarkers of sarcopenia in fall patients OTHER

Blood test, body composition (BIA and/or DXA), balance tests (sway), handgrip strength, isometric knee extension strength, chair-rise test, gait-speed, thickness of the thigh muscles (ultrasound), screening for sarcopenia (SARC-F), screening for malnutrition (SNAQ), screening for depression (GDS-15), screening for self-rated health (EQ-5D-5L), frailty (CSHA Frailty Scale)

Home-dwelling geriatric outpatients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of participants referred to the fall clinic at Gentofte Hospital

You may qualify if:

• Geriatric patients referred to out-patient clinic for fall assessments
• equal to or over the age of 65

You may not qualify if:

• age under 65 years
• participants who do not understand Danish
• severe communicative problems
• moderate to severe dementia or cognitive deficits
• no independent walking

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

Pernille Hansen

Copenhagen, Hellerup, 2900, Denmark

Location

Related Publications (3)

• Hansen P, Nygaard H, Praeger-Jahnsen L, Schultz M, Dela F, Aagaard P, Ryg J, Suetta C. GDF-15 plasma levels are elevated in mobility-limited older adults with frailty and sarcopenia-results from the BIOFRAIL study. Geroscience. 2025 Nov 25. doi: 10.1007/s11357-025-01946-6. Online ahead of print.

  PMID: 41286529 DERIVED

• Hansen P, Nygaard H, Schultz M, Dela F, Aagaard P, Ryg J, Suetta C. Frailty is associated with a history of falls among mobility-limited older adults-cross-sectional multivariate analysis from the BIOFRAIL study. Eur Geriatr Med. 2025 Aug;16(4):1283-1293. doi: 10.1007/s41999-025-01239-3. Epub 2025 May 27.

  PMID: 40423768 DERIVED

• Hansen P, Nygaard H, Ryg J, Kristensen MT, Suetta C. Applying both the 30-s and the 5-repetition sit-to-stand tests captures dissimilar groups and a broader spectrum of physical abilities in mobility-limited older individuals: results from the BIOFRAIL study. Eur Geriatr Med. 2025 Apr;16(2):703-707. doi: 10.1007/s41999-024-01115-6. Epub 2024 Dec 7.

  PMID: 39644455 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and Serum

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Charlotte Suetta, Professor

  Charlotte Suetta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, Dr.Med.

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 3, 2023
• Study Start: November 8, 2021
• Primary Completion: October 31, 2023
• Study Completion: June 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2024-10

Locations

DK (1)