The Prevalence of Malnutrition and Sarcopenia in Swiss Rehabilitation Settings (Malnut-Reha)

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Sarcopenia

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.

• Study Type: Observational
• Enrollment (Actual): 550

Contacts and Locations

• Study Contact: Name: Undine Lehmann, Dr.; Phone Number: +41 31 848 47 56; Email: undine.lehmann@bfh.ch
• Study Contact Backup: Name: Katja Uhlmann, MSc; Phone Number: +41 31 848 45 74; Email: katja.uhlmann@bfh.ch

Study Locations

• Switzerland
  • Barmelweid, Switzerland, 5017
    • Klinik Barmelweid AG
  • Basel, Switzerland, 4055
    • University Department of Geriatric Medicine FELIX PLATTER
  • Basel, Switzerland, 4055
    • REHAB Basel
  • Heiligenschwendi, Switzerland, 3625
    • Berner Reha Zentrum AG
  • Wald, Switzerland, 8636
    • Zürcher RehaZentren - Klinik Wald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Inpatients in rehabilitation clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Body weight	(in kg)	Within 7 days after admission
Height	(in cm)	Within 7 days after admission
Body Mass Index	(calculated by weight and height in kg/m2)	Within 7 days after admission
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
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
Muscle mass by Bioelectrical Impedance Analysis (BIA) - Part 1	Resistance (in Ohm) and Reactance (in Ohm)	Within 7 days after admission
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
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
Prevalence of malnutrition - overall	Overall prevalence of malnutrition will be reported in percent	Calculated through study completion after five months recruitment duration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Prevalence of sarcopenia - Overall	Overall prevalence of sarcopenia will be reported in percent	Calculated through study completion after five months recruitment duration
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)
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)
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)
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
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)

Collaborators and Investigators

• Sponsor: Undine Lehmann, Dr.
• Collaborators: Rehab Basel; Berner Reha Zentrum AG; Klinik Barmelweid; University Department of Geriatric Medicine FELIX PLATTER; Zürcher RehaZentrum Wald
• Investigators: Principal Investigator: Thimo Marcin, Dr., Berner Reha Zentrum

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; prevalence; sarcopenia; malnutrition; handgrip strength; Nutritional Risk Screening
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Nutrition Disorders; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Malnutrition
• Other Study ID Numbers: 2022-01098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No