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

NCT04151108 | Completed

• 1 other identifier: H-19039214
• Study Type: observational
• Target: 1,072
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Muscle Loss; Length of Stay

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Readmission

  Time to readmission 90 days from discharge

• Mortality

  Time to mortality 90 days from index admission

Study Arms (2)

Old medical patients

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

Geriatric patients

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; Other: Development of a risk assessment tool for loss of muscle mass and physical function based on clinical and functional measures and systemic biomarkers

Interventions

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

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)

Geriatric patients; Old medical patients

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

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)

Geriatric patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 33376179 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Charlotte Suetta, Professor

  Geriatric Research Unit, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, Dr.Med.

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 5, 2019
• Study Start: November 4, 2019
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

DK (1)