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

Study Overview
=================
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.

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

Conditions
-----------------
Sarcopenia, Muscle Loss, Length of Stay

Intervention / Treatment
-----------------
* Other: Development of a risk assessment tool based on clinical and functional measures and systemic biomarkers
* Other: Development of a risk assessment tool for loss of muscle mass and physical function based on clinical and functional measures and systemic biomarkers


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Old medical patients<br>Blood tests, frailty (CSHA Frailty Scale), risk of pressure ulcers (Braden Score), handgrip strength, chair-rise test, Orientation-Memory-Concentration test (OMC), screening for sarcopenia (SARC-F), screening for malnutrition (SNAQ), body composition. Will be assessed at admission | Other: Development of a risk assessment tool based on clinical and functional measures and systemic biomarkers<br>* 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)<br>|
| Geriatric patients<br>Blood tests, frailty (CSHA Frailty Scale), risk of pressure ulcers (Braden Score), handgrip strength, chair-rise test, gait-speed, Orientation-Memory-Concentration test (OMC), screening for sarcopenia (SARC-F), screening for malnutrition (SNAQ), body composition. Blood tests, physical function measures and body composition will be assessed at both admission and discharge. | Other: Development of a risk assessment tool based on clinical and functional measures and systemic biomarkers<br>* 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)<br>Other: Development of a risk assessment tool for loss of muscle mass and physical function based on clinical and functional measures and systemic biomarkers<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Hours of admission from index to discharge | From date of hospital admission until discharge, assessed up to 2 months | 
| Change in muscle mass | Relative change in muscle mass during hospitalization | Change from baseline muscle mass, assessed at admission, to muscle mass assessed at discharge, an average of 10 days | 
| Change in muscle strength | Change in handgrip strength during hospitalization | Change from baseline muscle strength, assessed at admission, to muscle strength assessed at discharge, an average of 10 days | 
| Change in physical function | Change in chair-rise and gait-speed ability during hospitalization | Change from baseline physical function, assessed at admission, to physical function assessed at discharge, an average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | Time to readmission from discharge | Time to readmission 90 days from discharge | 
| Mortality | Time to mortality from index admission | Time to mortality 90 days from index admission |