Biomarkers of Sarcopenia and Frailty in Geriatric Patients (BioFrail)

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Muscle Loss; Fall Patients
• Intervention / Treatment: Other: Assessing sarcopenia and potential biomarkers of sarcopenia in fall patients

• Study Type: Observational
• Enrollment (Actual): 508

Contacts and Locations

Study Locations

• Denmark
  • Hellerup
    • Copenhagen, Hellerup, Denmark, 2900
      • Pernille Hansen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Thickness	Determination of muscle thickness of the vastus laterals og rectus femoris assessed by ultrasound	Baseline
Muscle strength (upper body)	Determination of muscle strength measured by a handgrip dynamometer	Baseline
Muscle strength (lower body)	Determination of maximal isometric quadriceps muscle strength measured by a handheld dynamometer	Baseline
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	Baseline
Physical Activity (Gait speed)	Determination of physical activity assessed by habitual and maximal 6 meters walking speed	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: Bispebjerg Hospital
• Investigators: Principal Investigator: Charlotte Suetta, Professor, Charlotte Suetta

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Frailty; Sarcopenia
• Other Study ID Numbers: H-20057620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The following will be available: Study Protocol and Statistical Analysis Plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No