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Biomarkers for Length of Hospital Stay and Loss of Muscle Mass and Function in Old Medical Patients

The Copenhagen PROTECT Study: Biomarkers for Length of Hospital Stay and Loss of Muscle Mass and Function in Old Medical Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04151108
Acronym
PROTECT
Enrollment
1072
Registered
2019-11-05
Start date
2019-11-04
Completion date
2022-02-01
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Length of Stay, Muscle Loss, Sarcopenia

Brief summary

As humans age, there is a gradual loss of skeletal muscle mass and strength, termed sarcopenia. The underlying causes of sarcopenia are yet not fully elucidated but are thought to be multifactorial and include increased levels of systemic pro-inflammatory mediators, a decrease in anabolic hormones and changes in the neuromuscular system. Furthermore, physical inactivity, chronic diseases, immobilisation and hospitalisation are known to play an important part in the development of sarcopenia. The prevalence of sarcopenia ranges from 20-30% (aged \>70yrs) within the general community. However, the prevalence of sarcopenia in geriatric patients after an acute hospital admission is substantially higher, estimated at ≈50%. Furthermore, successive events of hospitalisation have been suggested to contribute to the development of sarcopenia, as even short periods (4-5 days) of skeletal muscle disuse are known to induce muscle atrophy. Mean length of hospital stay in geriatric wards due to acute illness or hip-fracture is typically 7 to 11 days during which the level of physical activity is strongly reduced leading to an accelerated loss of muscle mass that many older patients never recover from. Notably, a substantial part of the deterioration in functional capacity could be avoided just by counteracting loss of muscle mass during hospitalization. As such, we need to identify sensitive biological, clinical and functional biomarkers predicting loss of muscle mass and function during hospitalization to identify patients at risk of developing sarcopenia. Additionally, it is crucial to investigate the association of these biomarkers with hospital length of stay, as hospitalisation has been suggested to contribute to the development of sarcopenia while longer hospital stays may increase patient risk of hospital-acquired infections and place an economic burden on society.

Interventions

OTHERDevelopment of a risk assessment tool based on clinical and functional measures and systemic biomarkers

Blood tests, frailty (CSHA Clinical Frailty Scale) and risk of pressure ulcers (Braden Score), Early Warning Score (EWS), sarcopenia (SARC-F), malnutrition (SNAQ), cognitive status, comorbidity (Charlson comorbidity Index), polypharmacy, muscle strength, and body composition (BIA)

OTHERDevelopment of a risk assessment tool for loss of muscle mass and physical function based on clinical and functional measures and systemic biomarkers

Blood tests, frailty (CSHA Clinical Frailty Scale), Early Warning Score (EWS), cognitive status, sarcopenia (SARC-f), malnutrition (SNAQ), comorbidity (Charlson comorbidity Index), polypharmacy, physical function, physical performance, and body composition (BIA)

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* equal to or over the age of 65 * admitted to the acute ward at Bispebjerg Hospital

Exclusion criteria

* age under 65 years * terminal illness * participants who do not understand Danish * participants in isolation with airborne or droplet infections

Design outcomes

Primary

MeasureTime frameDescription
Length of stayFrom date of hospital admission until discharge, assessed up to 2 monthsHours of admission from index to discharge
Change in muscle massChange from baseline muscle mass, assessed at admission, to muscle mass assessed at discharge, an average of 10 daysRelative change in muscle mass during hospitalization
Change in muscle strengthChange from baseline muscle strength, assessed at admission, to muscle strength assessed at discharge, an average of 10 daysChange in handgrip strength during hospitalization
Change in physical functionChange from baseline physical function, assessed at admission, to physical function assessed at discharge, an average of 10 daysChange in chair-rise and gait-speed ability during hospitalization

Secondary

MeasureTime frameDescription
ReadmissionTime to readmission 90 days from dischargeTime to readmission from discharge
MortalityTime to mortality 90 days from index admissionTime to mortality from index admission

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026