The Prevalence of Malnutrition and Sarcopenia in Swiss Rehabilitation Settings

Sarcopenia Clinical Trial

— Malnut-Reha  

Official title:

The Prevalence of Malnutrition and Sarcopenia in Swiss Rehabilitation Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05639985
• Other study ID #: 2022-01098
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: April 14, 2023

Study information

• Verified date: April 2023
• Source: Bern University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: April 14, 2023
• Est. primary completion date: March 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Sarcopenia

Locations

Country	Name	City	State
Switzerland	Klinik Barmelweid AG	Barmelweid
Switzerland	REHAB Basel	Basel
Switzerland	University Department of Geriatric Medicine FELIX PLATTER	Basel
Switzerland	Berner Reha Zentrum AG	Heiligenschwendi
Switzerland	Zürcher RehaZentren - Klinik Wald	Wald

Sponsors (6)

Lead Sponsor	Collaborator
Undine Lehmann, Dr.	Berner Reha Zentrum AG, Klinik Barmelweid, Rehab Basel, University Department of Geriatric Medicine FELIX PLATTER, Zürcher RehaZentrum Wald

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. Erratum In: Age Ageing. 2019 Jul 1;48(4):601. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of malnutrition - Risk for malnutrition	The risk for malnutrition will be screened by the Nutritional Risk Screening (NRS-2002, in points). NRS has a scale from 0 to 7 points; higher points indicate a higher risk for malnutrition.	Within 7 days after admission
Primary	Body weight	(in kg)	Within 7 days after admission
Primary	Height	(in cm)	Within 7 days after admission
Primary	Body Mass Index	(calculated by weight and height in kg/m2)	Within 7 days after admission
Primary	Weight loss	Weight loss (in percent in six categories - <5 percent within the last 6 months, 5-10 percent within the last 6 months, >10 percent within the last 6 months; <10 percent in more than 6 months, 10 -20 percent in more than 6 months, >20 percent in more than 6 months)	Within 7 days after admission
Primary	Reduced energy intake	Reduced energy intake (in percent of intake versus requirement in three categories: less than 50 percent of energy requirement covered for more than 1 week, any reduced energy intake versus requirement for >2 weeks, no reduced energy intake)	Within 7 days after admission
Primary	Muscle mass by Bioelectrical Impedance Analysis (BIA) - Part 1	Resistance (in Ohm) and Reactance (in Ohm)	Within 7 days after admission
Primary	Muscle mass by Bioelectrical Impedance Analysis (BIA) - Part 2	Resistance (in Ohm) and Reactance (in Ohm) measured with BIA are combined with further information on weight, height, sex and age to calculate the appendicular skeletal muscle mass index (in kg/m2)	Within 7 days after admission
Primary	Prevalence of malnutrition - Confirmed diagnosis and severity of malnutrition	In case of positive screening, diagnosis of malnutrition will be confirmed and severity assessed according to the Global Leadership Initiative on Malnutrition (GLIM) criteria using the following measures described above: weight (in kg); height (in cm); Body Mass Index (calculated by weight and height in kg/m2); weight loss (in percent in six categories - <5 percent within the last 6 months, 5-10 percent within the last 6 months, >10 percent within the last 6 months; <10 percent in more than 6 months, 10 -20 percent in more than 6 months, >20 percent in more than 6 months); reduced energy intake (in percent of intake versus requirement in three categories: less than 50 percent of energy requirement covered for more than 1 week, any reduced energy intake versus requirement for >2 weeks, no reduced energy intake); Bioelectrical impedance analysis for muscle mass: resistance (in Ohm), reactance (in Ohm), Appendicular skeletal muscle mass index (in kg/m2)	Within 7 days after admission
Primary	Prevalence of malnutrition - overall	Overall prevalence of malnutrition will be reported in percent	Calculated through study completion after five months recruitment duration
Secondary	Prevalence of sarcopenia - Risk for sarcopenia by SARC-F	according to European Working Group on Sarcopenia in Older People (EWGSOP2) criteria. Screening will be performed by the Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire (in points). SARC-F has a scale from 0 - 10 with higher score indicating higher risk for sarcopenia.	Within 7 days after admission
Secondary	Prevalence of sarcopenia - Risk for sarcopenia by handgrip strength	according to European Working Group on Sarcopenia in Older People (EWGSOP2) criteria. Screening will be performed by handgrip strength (in kPa)	Within 7 days after admission
Secondary	Prevalence of sarcopenia - Risk for sarcopenia	according to European Working Group on Sarcopenia in Older People (EWGSOP2) criteria. Screening will be performed by Chair Stand Test (in seconds)	Within 7 days after admission
Secondary	Prevalence of sarcopenia - Diagnosis of sarcopenia	In case of positive screening, muscle mass will be measured by BIA via resistance (in Ohm), reactance (in Ohm). Resistance (in Ohm) and Reactance (in Ohm) measured by BIA is combined with further information on weight, height, sex and age to calculate the appendicular skeletal muscle mass index in kg/m2. Diagnosis is confirmed if the appendicular skeletal muscle mass index is below a threshold (<7.0 kg/m2 for male and < 5.5. kg/m2 for female).	Within 7 days after admission
Secondary	Prevalence of sarcopenia - Severity of sarcopenia	In case of positive screening, severity of sarcopenia will be analysed by Timed Up and Go Test (in seconds).	Within 7 days after admission
Secondary	Prevalence of sarcopenia - Overall	Overall prevalence of sarcopenia will be reported in percent	Calculated through study completion after five months recruitment duration
Secondary	Changes of handgrip strength between admission and discharge of rehabilitation	Handgrip strength (in kPa)	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)
Secondary	Changes of body weight between admission and discharge of rehabilitation	body weight (in kg)	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)
Secondary	Changes of BMI between admission and discharge of rehabilitation	BMI (calculated in kg/m2)	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)
Secondary	Changes of Functional Independence Measure between admission and discharge of rehabilitation	Functional Independence Measure (FIM) (in points). FIM has a scale from 18 to 126 points. Higher points indicate a higher independence for activities of daily living.	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)