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

August 22, 2022 updated by: Charlotte Suetta, Bispebjerg Hospital

The Copenhagen PROTECT Study: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1072

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

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
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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: From date of hospital admission until discharge, assessed up to 2 months
Hours of admission from index to discharge
From date of hospital admission until discharge, assessed up to 2 months
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 from baseline muscle mass, assessed at admission, to muscle mass assessed at discharge, an average of 10 days
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
Change from baseline muscle strength, assessed at admission, to muscle strength assessed at discharge, an average of 10 days
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 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 Frame: Time to readmission 90 days from discharge
Time to readmission from discharge
Time to readmission 90 days from discharge
Mortality
Time Frame: Time to mortality 90 days from index admission
Time to mortality from index admission
Time to mortality 90 days from index admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Charlotte Suetta, Professor, Geriatric Research Unit, Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19039214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The following will be available: Study Protocol and Statistical Analysis Plan (SAP).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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