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Clinical Trials/NCT04151108
NCT04151108
Completed
Not Applicable

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

Bispebjerg Hospital1 site in 1 country1,072 target enrollmentNovember 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Bispebjerg Hospital
Enrollment
1072
Locations
1
Primary Endpoint
Length of stay
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 4, 2019
End Date
February 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charlotte Suetta

Professor, MD, Dr.Med.

Bispebjerg Hospital

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

Outcomes

Primary Outcomes

Length of stay

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

Hours of admission from index to discharge

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

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

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

Secondary Outcomes

  • Readmission(Time to readmission 90 days from discharge)
  • Mortality(Time to mortality 90 days from index admission)

Study Sites (1)

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