BioFrail: Biomarkers of Sarcopenia and Frailty in Geriatric Patients

Sponsor
Herlev and Gentofte Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05795556
Collaborator
Bispebjerg Hospital (Other)
800
1
25.7
31.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Assessing sarcopenia and potential biomarkers of sarcopenia in fall patients

Study Design

Study Type:
Observational
Anticipated Enrollment :
800 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Biomarkers of Sarcopenia and Frailty in Geriatric Patients
Actual Study Start Date :
Nov 8, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Skeletal muscle mass [Baseline]

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

  2. Appendicular lean muscle mass [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) [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 Outcome Measures

  1. Muscle Thickness [Baseline]

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

  2. Muscle strength (upper body) [Baseline]

    Determination of muscle strength measured by a handgrip dynamometer

  3. Muscle strength (lower body) [Baseline]

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

  4. Physical Activity (Chair rise) [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) [Baseline]

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

  6. Postural sway [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pernille Hansen Copenhagen Hellerup Denmark 2900

Sponsors and Collaborators

  • Herlev and Gentofte Hospital
  • Bispebjerg Hospital

Investigators

  • Principal Investigator: Charlotte Suetta, Professor, Charlotte Suetta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Charlotte Suetta, Professor, MD, Dr.Med., Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier:
NCT05795556
Other Study ID Numbers:
  • H-20057620
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 3, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 3, 2023