Skip to main content
OpenTrials
Completed

NCT Number: NCT04151108

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Length of stay

    Time frame: From date of hospital admission until discharge, assessed up to 2 months

    Hours of admission from index to discharge

  2. Change in muscle mass

    Time frame: Change from baseline muscle mass, assessed at admission, to muscle mass assessed at discharge, an average of 10 days

    Relative change in muscle mass during hospitalization

  3. Change in muscle strength

    Time frame: Change from baseline muscle strength, assessed at admission, to muscle strength assessed at discharge, an average of 10 days

    Change in handgrip strength during hospitalization

  4. Change in physical function

    Time frame: Change from baseline physical function, assessed at admission, to physical function assessed at discharge, an average of 10 days

    Change in chair-rise and gait-speed ability during hospitalization

Secondary outcomes

  1. Readmission

    Time frame: Time to readmission 90 days from discharge

    Time to readmission from discharge

  2. Mortality

    Time frame: Time to mortality 90 days from index admission

    Time to mortality from index admission

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Acronym: PROTECT

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Nov 5, 2019
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.