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

NCT ID: NCT04151108

Last Updated: 2022-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1072 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-04

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia Muscle Loss Length of Stay

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Development of a risk assessment tool based on clinical and functional measures and systemic biomarkers

Intervention Type 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)

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.

Development of a risk assessment tool based on clinical and functional measures and systemic biomarkers

Intervention Type 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

Intervention Type 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)

Interventions

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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)

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Charlotte Suetta

Professor, MD, Dr.Med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charlotte Suetta, Professor

Role: PRINCIPAL_INVESTIGATOR

Geriatric Research Unit, Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Kamper RS, Schultz M, Hansen SK, Andersen H, Ekmann A, Nygaard H, Helland F, Wejse MR, Rahbek CB, Noerst T, Pressel E, Nielsen FE, Suetta C. Biomarkers for length of hospital stay, changes in muscle mass, strength and physical function in older medical patients: protocol for the Copenhagen PROTECT study-a prospective cohort study. BMJ Open. 2020 Dec 29;10(12):e042786. doi: 10.1136/bmjopen-2020-042786.

Reference Type DERIVED
PMID: 33376179 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H-19039214

Identifier Type: -

Identifier Source: org_study_id

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