Clinical trial NCT05639985: The Prevalence of Malnutrition and Sarcopenia in Swiss Rehabilitation Settings
Official title: The Prevalence of Malnutrition and Sarcopenia in Swiss Rehabilitation Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Sarcopenia
Keywords: malnutrition
sarcopenia
rehabilitation
prevalence
Nutritional Risk Screening
handgrip strength
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Berner Reha Zentrum AG
name: Klinik Barmelweid
name: University Department of Geriatric Medicine FELIX PLATTER
name: Zürcher RehaZentrum Wald
name: Rehab Basel
First posted: 2022-12-07
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients in rehabilitation clinic

Brief summary: The aim of the study is to identify the prevalence of malnutrition and sarcopenia in patients admitted in Swiss rehabilitation centers. Furthermore, the aim is to investigate the changes of selected malnutrition and sarcopenia parameters over the length of the rehabilitation stay.

Detailed description: The project aims to investigate the prevalence of malnutrition and sarcopenia in the rehabilitation setting. A cross-sectional national multicenter study will be conducted in five rehabilitation centers in Switzerland, including 80 - 130 participants per center for the primary objective (prevalence study). Patients will be screened for malnutrition and sarcopenia with established screening tools and if an elevated risk is observed, diagnosis will be confirmed and severity investigated according to international guidelines. Furthermore, the evolution of selected malnutrition and sarcopenia parameters over the rehabilitation stay should be assessed.

Eligibility criteria: Inclusion Criteria:

Patients treated in the following groups of rehabilitations will be included:

* Geriatric rehabilitation
* Pulmonal rehabilitation
* Cardiovascular rehabilitation
* Neurological rehabilitation
* Musculoskeletal rehabilitation
* Internistic rehabilitation and oncological rehabilitation

Exclusion criteria:

* Inability to give informed consent
* Inability to follow study procedures (e.g., due to delirium or language barriers)
* Expected life expectancy \< 3 months and/or palliative care
* Isolation for example due to Covid-19 infection or tuberculosis
* Severe dehydration/ volume overload
* Medical conditions that prevent conducting a Bioelectrical Impedance Analysis (BIA) measurement (e.g. non-removable plasters or bandages at feet or hands) or defibrillator

Primary outcomes:
measure: Prevalence of malnutrition - Risk for malnutrition
timeFrame: Within 7 days after admission
measure: Body weight
timeFrame: Within 7 days after admission
measure: Height
timeFrame: Within 7 days after admission
measure: Body Mass Index
timeFrame: Within 7 days after admission
measure: Weight loss
timeFrame: Within 7 days after admission
measure: Reduced energy intake
timeFrame: Within 7 days after admission
measure: Muscle mass by Bioelectrical Impedance Analysis (BIA) - Part 1
timeFrame: Within 7 days after admission
measure: Muscle mass by Bioelectrical Impedance Analysis (BIA) - Part 2
timeFrame: Within 7 days after admission
measure: Prevalence of malnutrition - Confirmed diagnosis and severity of malnutrition
timeFrame: Within 7 days after admission
measure: Prevalence of malnutrition - overall
timeFrame: Calculated through study completion after five months recruitment duration
Secondary outcomes:
measure: Prevalence of sarcopenia - Risk for sarcopenia by SARC-F
timeFrame: Within 7 days after admission
measure: Prevalence of sarcopenia - Risk for sarcopenia by handgrip strength
timeFrame: Within 7 days after admission
measure: Prevalence of sarcopenia - Risk for sarcopenia
timeFrame: Within 7 days after admission
measure: Prevalence of sarcopenia - Diagnosis of sarcopenia
timeFrame: Within 7 days after admission
measure: Prevalence of sarcopenia - Severity of sarcopenia
timeFrame: Within 7 days after admission
measure: Prevalence of sarcopenia - Overall
timeFrame: Calculated through study completion after five months recruitment duration
measure: Changes of handgrip strength between admission and discharge of rehabilitation
timeFrame: At admission and 21 days after admission (or, if admission occurs before 21 days and the length of stay was at least 14 days than within 3 days before discharge)
measure: Changes of body weight between admission and discharge of rehabilitation
timeFrame: At admission and 21 days after admission (or, if admission occurs before 21 days and the length of stay was at least 14 days than within 3 days before discharge)
measure: Changes of BMI between admission and discharge of rehabilitation
timeFrame: At admission and 21 days after admission (or, if admission occurs before 21 days and the length of stay was at least 14 days than within 3 days before discharge)
measure: Changes of Functional Independence Measure between admission and discharge of rehabilitation
timeFrame: At admission and 21 days after admission (or, if admission occurs before 21 days and the length of stay was at least 14 days than within 3 days before discharge)
Other outcomes:
Locations:
city: Barmelweid
country: Switzerland
facility: Klinik Barmelweid AG
city: Basel
country: Switzerland
facility: REHAB Basel
city: Basel
country: Switzerland
facility: University Department of Geriatric Medicine FELIX PLATTER
city: Heiligenschwendi
country: Switzerland
facility: Berner Reha Zentrum AG
city: Wald
country: Switzerland
facility: Zürcher RehaZentren - Klinik Wald
Study officials:
affiliation: Berner Reha Zentrum
name: Thimo Marcin, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
citation: Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
citation: Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.