Biomarkers of Sarcopenia and Frailty in Geriatric Patients

Sarcopenia Clinical Trial

— BioFrail  

Official title:

Biomarkers of Sarcopenia and Frailty in Geriatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795556
• Other study ID #: H-20057620
• Status: Recruiting
• Start date: November 8, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Herlev and Gentofte Hospital
• Contact: Pernille Hansen, MSc
• Phone: 26298831
• Email: pernille.hansen.14[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall Patients
• Frailty
• Muscle Loss
• Sarcopenia

Intervention

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)

Locations

Country	Name	City	State
Denmark	Pernille Hansen	Copenhagen	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle mass	Determination of skeletal muscle mass measured by Bioelectrical Impedance analysis (BIA Inbody770)	Baseline
Primary	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
Primary	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	Muscle Thickness	Determination of muscle thickness of the vastus laterals og rectus femoris assessed by ultrasound	Baseline
Secondary	Muscle strength (upper body)	Determination of muscle strength measured by a handgrip dynamometer	Baseline
Secondary	Muscle strength (lower body)	Determination of maximal isometric quadriceps muscle strength measured by a handheld dynamometer	Baseline
Secondary	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
Secondary	Physical Activity (Gait speed)	Determination of physical activity assessed by habitual and maximal 6 meters walking speed	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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