AzTrials
AzTrials

MalnutritionMalnut-RehaNCT05639985

The Prevalence of Malnutrition and Sarcopenia in Swiss Rehabilitation Settings

An observational study of Malnutrition and Sarcopenia, run by Undine Lehmann, Dr. at 5 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malnutrition, Sarcopenia
How many people
550 participants
Where
5 sitesSwitzerland
Study dates
1 Nov 2022to 14 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Inpatients in rehabilitation clinic

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Switzerland5 sites

  • Klinik Barmelweid AG

    Barmelweid, 5017

  • REHAB Basel

    Basel, 4055

  • University Department of Geriatric Medicine FELIX PLATTER

    Basel, 4055

  • Berner Reha Zentrum AG

    Heiligenschwendi, 3625

  • Zürcher RehaZentren - Klinik Wald

    Wald, 8636

Other trials in Switzerland

About this study

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.

Keywords
malnutrition, sarcopenia, rehabilitation, prevalence, Nutritional Risk Screening, handgrip strength
Medical subject headings
Malnutrition, Sarcopenia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 7 days after admission

  2. Body weight

    (in kg)

    Measured: Within 7 days after admission

  3. Height

    (in cm)

    Measured: Within 7 days after admission

  4. Body Mass Index

    (calculated by weight and height in kg/m2)

    Measured: 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)

    Measured: 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)

    Measured: Within 7 days after admission

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

    Resistance (in Ohm) and Reactance (in Ohm)

    Measured: 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)

    Measured: 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)

    Measured: Within 7 days after admission

  10. Prevalence of malnutrition - overall

    Overall prevalence of malnutrition will be reported in percent

    Measured: Calculated through study completion after five months recruitment duration

Secondary outcomes (10)

  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.

    Measured: 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)

    Measured: 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)

    Measured: 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).

    Measured: 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).

    Measured: Within 7 days after admission

  6. Prevalence of sarcopenia - Overall

    Overall prevalence of sarcopenia will be reported in percent

    Measured: Calculated through study completion after five months recruitment duration

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

    Handgrip strength (in kPa)

    Measured: 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)

    Measured: 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)

    Measured: 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2022
  2. Study start1 Nov 2022
  3. Primary completion31 Mar 2023
  4. Study completion14 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05639985
Sponsor's protocol ID
2022-01098
Acronym
Malnut-Reha
Status last verified
Apr 2023
First submitted
28 Oct 2022
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Malnutrition and Sarcopenia, run by Undine Lehmann, Dr. at 5 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of malnutrition - Risk for malnutrition (time frame: Within 7 days after admission). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05639985, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in