Clinical trial NCT04151108: Biomarkers for Length of Hospital Stay and Loss of Muscle Mass and Function in Old Medical Patients
Official title: The Copenhagen PROTECT Study: Biomarkers for Length of Hospital Stay and Loss of Muscle Mass and Function in Old Medical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Muscle Loss
Length of Stay
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 1072
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of participants admitted to the acute ward and the geriatric ward at Bispebjerg Hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of stay
timeFrame: From date of hospital admission until discharge, assessed up to 2 months
measure: Change in muscle mass
timeFrame: Change from baseline muscle mass, assessed at admission, to muscle mass assessed at discharge, an average of 10 days
measure: Change in muscle strength
timeFrame: Change from baseline muscle strength, assessed at admission, to muscle strength assessed at discharge, an average of 10 days
measure: Change in physical function
timeFrame: Change from baseline physical function, assessed at admission, to physical function assessed at discharge, an average of 10 days
Secondary outcomes:
measure: Readmission
timeFrame: Time to readmission 90 days from discharge
measure: Mortality
timeFrame: Time to mortality 90 days from index admission
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Geriatric Research Unit, Bispebjerg Hospital
name: Charlotte Suetta, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamper RS, Schultz M, Hansen SK, Andersen H, Ekmann A, Nygaard H, Helland F, Wejse MR, Rahbek CB, Noerst T, Pressel E, Nielsen FE, Suetta C. Biomarkers for length of hospital stay, changes in muscle mass, strength and physical function in older medical patients: protocol for the Copenhagen PROTECT study-a prospective cohort study. BMJ Open. 2020 Dec 29;10(12):e042786. doi: 10.1136/bmjopen-2020-042786.