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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04151108
Other study ID # H-19039214
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 4, 2019
Est. completion date February 1, 2022

Study information

Verified date August 2022
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1072
Est. completion date February 1, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Development 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)
Development 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)

Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of stay Hours of admission from index to discharge From date of hospital admission until discharge, assessed up to 2 months
Primary 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
Primary 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
Primary 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 Readmission Time to readmission from discharge Time to readmission 90 days from discharge
Secondary Mortality Time to mortality from index admission Time to mortality 90 days from index admission
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