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OpenTrials
Completed

NCT Number: NCT05795556

Biomarkers of Sarcopenia and Frailty in Geriatric Patients

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.

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Key information

Conditions

Sarcopenia Atrophy Fall Patients Muscle Loss Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pernille Hansen

Copenhagen, Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Skeletal muscle mass

    Time frame: Baseline

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

  2. Appendicular lean muscle mass

    Time frame: Baseline

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

  3. Skeletal muscle mass index (SMI)

    Time frame: Baseline

    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)

Secondary outcomes

  1. Muscle Thickness

    Time frame: Baseline

    Determination of muscle thickness of the vastus laterals og rectus femoris assessed by ultrasound

  2. Muscle strength (upper body)

    Time frame: Baseline

    Determination of muscle strength measured by a handgrip dynamometer

  3. Muscle strength (lower body)

    Time frame: Baseline

    Determination of maximal isometric quadriceps muscle strength measured by a handheld dynamometer

  4. Physical Activity (Chair rise)

    Time frame: Baseline

    Determination of physical activity assessed by 30 s sit-to-stand chair rise test and five times sit-to-stand test

  5. Physical Activity (Gait speed)

    Time frame: Baseline

    Determination of physical activity assessed by habitual and maximal 6 meters walking speed

  6. Postural sway

    Time frame: Baseline

    Determination 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.

  7. SARC-F (sarcopenia screening)

    Time frame: Baseline

    The 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.

  8. Geriatric Depression Scale (GDS-15)

    Time frame: Baseline

    GDS-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.

  9. SNAQ (malnutrition)

    Time frame: Baseline

    The 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.

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

  • Bispebjerg Hospital

Registry information

Acronym: BioFrail

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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