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SarcopeniaBioFrailNCT05795556

Biomarkers of Sarcopenia and Frailty in Geriatric Patients

An observational study of Sarcopenia and Muscle Loss, run by Herlev and Gentofte Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Sarcopenia, Muscle Loss, Fall Patients
What is being tested?
Assessing sarcopenia and potential biomarkers of sarcopenia in fall patients
How many people
508 participants
Where
1 siteDenmark
Study dates
8 Nov 2021to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Pernille Hansen

    Copenhagen, Hellerup, 2900

Other trials in Denmark

About this study

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.

Being tested
Assessing sarcopenia and potential biomarkers of sarcopenia in fall patients
Medical subject headings
Sarcopenia, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessing sarcopenia and potential biomarkers of sarcopenia in fall patientsOther

    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)

Study groups in NCT05795556
Study groupRoleWhat they receive
Home-dwelling geriatric outpatientsHome-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)
Receives: Other: Assessing sarcopenia and potential biomarkers of sarcopenia in fall patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skeletal muscle mass

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

    Measured: Baseline

  2. 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)

    Measured: Baseline

  3. 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)

    Measured: Baseline

Secondary outcomes (9)

  1. Muscle Thickness

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

    Measured: Baseline

  2. Muscle strength (upper body)

    Determination of muscle strength measured by a handgrip dynamometer

    Measured: Baseline

  3. Muscle strength (lower body)

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

    Measured: Baseline

  4. Physical Activity (Chair rise)

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

    Measured: Baseline

  5. Physical Activity (Gait speed)

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

    Measured: Baseline

  6. Postural sway

    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.

    Measured: Baseline

  7. SARC-F (sarcopenia screening)

    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.

    Measured: Baseline

  8. Geriatric Depression Scale (GDS-15)

    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.

    Measured: Baseline

  9. SNAQ (malnutrition)

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start8 Nov 2021
  3. Primary completion31 Oct 2023
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05795556
Sponsor's protocol ID
H-20057620
Acronym
BioFrail
Status last verified
Oct 2024
First submitted
3 Mar 2023
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The following will be available: Study Protocol and Statistical Analysis Plan

Publications

  • 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. 2026 Apr;48(2):1955-1966. doi: 10.1007/s11357-025-01946-6. Epub 2025 Nov 25.

    PubMed 41286529

  • 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.

    PubMed 40423768

  • 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.

    PubMed 39644455

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Muscle Loss, run by Herlev and Gentofte Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skeletal muscle mass (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05795556, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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