ClinicalTrials.gg
CompletedNCT05639985Malnut-RehaUpdated Apr 25, 2023

The Prevalence of Malnutrition and Sarcopenia in Swiss Rehabilitation Settings

An observational study in Malnutrition and Sarcopenia, sponsored by Undine Lehmann, Dr.. Completed at 5 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Undine Lehmann, Dr. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
550
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malnutrition
  • Sarcopenia

Keywords

  • malnutrition
  • sarcopenia
  • rehabilitation
  • prevalence
  • Nutritional Risk Screening
  • handgrip strength
03

In context

Malnutrition

1,619 studies on the registry are indexed under Malnutrition; 241 are open to participants now.

This study's enrollment of 550 is above the median of 206 across 401 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

This is the only study on the registry with Undine Lehmann, Dr. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Inpatients in rehabilitation clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
550 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 7 days after admission

  2. Body weight

    (in kg)

    Time frame: Within 7 days after admission

  3. Height

    (in cm)

    Time frame: Within 7 days after admission

  4. Body Mass Index

    (calculated by weight and height in kg/m2)

    Time frame: Within 7 days after admission

  5. 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)

    Time frame: Within 7 days after admission

  6. 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)

    Time frame: Within 7 days after admission

  7. Muscle mass by Bioelectrical Impedance Analysis (BIA) - Part 1

    Resistance (in Ohm) and Reactance (in Ohm)

    Time frame: Within 7 days after admission

  8. 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)

    Time frame: Within 7 days after admission

  9. 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)

    Time frame: Within 7 days after admission

  10. Prevalence of malnutrition - overall

    Overall prevalence of malnutrition will be reported in percent

    Time frame: Calculated through study completion after five months recruitment duration

Secondary outcomes

  1. 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.

    Time frame: Within 7 days after admission

  2. 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)

    Time frame: Within 7 days after admission

  3. 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)

    Time frame: Within 7 days after admission

  4. 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).

    Time frame: Within 7 days after admission

  5. 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).

    Time frame: Within 7 days after admission

  6. Prevalence of sarcopenia - Overall

    Overall prevalence of sarcopenia will be reported in percent

    Time frame: Calculated through study completion after five months recruitment duration

  7. Changes of handgrip strength between admission and discharge of rehabilitation

    Handgrip strength (in kPa)

    Time frame: 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)

  8. Changes of body weight between admission and discharge of rehabilitation

    body weight (in kg)

    Time frame: 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)

  9. Changes of BMI between admission and discharge of rehabilitation

    BMI (calculated in kg/m2)

    Time frame: 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)

  10. 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.

    Time frame: 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)

07

Study locations

5 sites
  • Klinik Barmelweid AG
    Barmelweid, 5017, Switzerland
  • REHAB Basel
    Basel, 4055, Switzerland
  • University Department of Geriatric Medicine FELIX PLATTER
    Basel, 4055, Switzerland
  • Berner Reha Zentrum AG
    Heiligenschwendi, 3625, Switzerland
  • Zürcher RehaZentren - Klinik Wald
    Wald, 8636, Switzerland
08

References and documents

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. PubMed 30181091 ↗
  • 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. PubMed 30312372 ↗
  • 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. PubMed 12765673 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05639985
Lead sponsor
Undine Lehmann, Dr.
Collaborators
Berner Reha Zentrum AG, Klinik Barmelweid, University Department of Geriatric Medicine FELIX PLATTER, Zürcher RehaZentrum Wald, Rehab Basel
Responsible party
Undine Lehmann, Dr. (Lecturer, Bern University of Applied Sciences) — Sponsor-investigator
First posted
Dec 7, 2022
Start date
Nov 1, 2022
Primary completion
Mar 31, 2023
Completion
Apr 14, 2023
Last update
Apr 25, 2023

Study contacts

Thimo Marcin, Dr.
principal investigator · Berner Reha Zentrum

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion