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Biomarkers of Sarcopenia and Frailty in Geriatric Patients

Biomarkers of Sarcopenia and Frailty in Geriatric Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05795556
Acronym
BioFrail
Enrollment
508
Registered
2023-04-03
Start date
2021-11-08
Completion date
2024-06-30
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall Patients, Muscle Loss, Sarcopenia

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.

Interventions

OTHERAssessing sarcopenia and potential biomarkers of sarcopenia in fall patients

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)

Sponsors

Bispebjerg Hospital
CollaboratorOTHER
Herlev and Gentofte Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Skeletal muscle massBaselineDetermination of skeletal muscle mass measured by Bioelectrical Impedance analysis (BIA Inbody770)
Appendicular lean muscle massBaselineDetermination of appendicular lean muscle mass (The sum of the lean tissue is the arms and legs) measured by Bioelectrical Impedance analysis (BIA Inbody770)
Skeletal muscle mass index (SMI)BaselineDetermination 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)

Secondary

MeasureTime frameDescription
Muscle strength (upper body)BaselineDetermination of muscle strength measured by a handgrip dynamometer
Muscle strength (lower body)BaselineDetermination of maximal isometric quadriceps muscle strength measured by a handheld dynamometer
Physical Activity (Chair rise)BaselineDetermination of physical activity assessed by 30 s sit-to-stand chair rise test and five times sit-to-stand test
Physical Activity (Gait speed)BaselineDetermination of physical activity assessed by habitual and maximal 6 meters walking speed
Geriatric Depression Scale (GDS-15)BaselineGDS-15 is used as a screening tool to facilitate assessment of depression. Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
SNAQ (malnutrition)BaselineThe Short Nutritional Assessment Questionnaire (SNAQ) is used as a screening tool to get an insight into patients' nutritional status. Patients with 2 points were classified as moderately malnourished and patients with 3 points or more are classified as severely malnourished.
SARC-F (sarcopenia screening)BaselineThe SARC-F questionnaire is used as a screening tool to identify probable sarcopenia patients. The scores range from 0 to 10, with 0 to 2 points for each component. Studies suggested that a score equal to or greater than 4 is predictive of sarcopenia and poor outcomes.
Postural swayBaselineDetermination of postural sway will be evaluated with a HUR balance force plate. This device is a precision device that provides objectively measurable data. Thanks to its movable platform, it can measure in all directions. The patients will be performing three balance test; Romberg balance test, tandem test and 15 s one-leg-stand.
Muscle ThicknessBaselineDetermination of muscle thickness of the vastus laterals og rectus femoris assessed by ultrasound

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026