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

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04151108
Collaborator
(none)
1,072
1
26.9
39.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1072 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Copenhagen PROTECT Study: Biomarkers for Length of Hospital Stay and Loss of Muscle Mass and Function in Old Medical Patients
Actual Study Start Date :
Nov 4, 2019
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Length of stay [From date of hospital admission until discharge, assessed up to 2 months]

    Hours of admission from index to discharge

  2. Change in muscle mass [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 [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 [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 Outcome Measures

  1. Readmission [Time to readmission 90 days from discharge]

    Time to readmission from discharge

  2. Mortality [Time to mortality 90 days from index admission]

    Time to mortality from index admission

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bispebjerg Hospital Copenhagen Denmark 2400

Sponsors and Collaborators

  • Bispebjerg Hospital

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Charlotte Suetta, Professor, MD, Dr.Med., Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT04151108
Other Study ID Numbers:
  • H-19039214
First Posted:
Nov 5, 2019
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022