NCT05639985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

October 28, 2022

Last Update Submit

April 24, 2023

Conditions

Keywords

malnutritionsarcopeniarehabilitationprevalenceNutritional Risk Screeninghandgrip strength

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (10)

  • Prevalence of sarcopenia - Risk for sarcopenia by SARC-F

    Within 7 days after admission

  • Prevalence of sarcopenia - Risk for sarcopenia by handgrip strength

    Within 7 days after admission

  • Prevalence of sarcopenia - Risk for sarcopenia

    Within 7 days after admission

  • Prevalence of sarcopenia - Diagnosis of sarcopenia

    Within 7 days after admission

  • Prevalence of sarcopenia - Severity of sarcopenia

    Within 7 days after admission

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Inpatients in rehabilitation clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinik Barmelweid AG

Barmelweid, 5017, Switzerland

Location

REHAB Basel

Basel, 4055, Switzerland

Location

University Department of Geriatric Medicine FELIX PLATTER

Basel, 4055, Switzerland

Location

Berner Reha Zentrum AG

Heiligenschwendi, 3625, Switzerland

Location

Zürcher RehaZentren - Klinik Wald

Wald, 8636, Switzerland

Location

Related 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.

    PMID: 30181091BACKGROUND
  • 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.

    PMID: 30312372BACKGROUND
  • 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.

    PMID: 12765673BACKGROUND

MeSH Terms

Conditions

MalnutritionSarcopenia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Thimo Marcin, Dr.

    Berner Reha Zentrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 28, 2022

First Posted

December 7, 2022

Study Start

November 1, 2022

Primary Completion

March 31, 2023

Study Completion

April 14, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations