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

April 24, 2023 updated by: Undine Lehmann, Dr.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of malnutrition - Risk for malnutrition
Time Frame: Within 7 days after admission
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
Time Frame: Within 7 days after admission
(in kg)
Within 7 days after admission
Height
Time Frame: Within 7 days after admission
(in cm)
Within 7 days after admission
Body Mass Index
Time Frame: Within 7 days after admission
(calculated by weight and height in kg/m2)
Within 7 days after admission
Weight loss
Time Frame: Within 7 days after admission
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
Time Frame: Within 7 days after admission
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
Time Frame: Within 7 days after admission
Resistance (in Ohm) and Reactance (in Ohm)
Within 7 days after admission
Muscle mass by Bioelectrical Impedance Analysis (BIA) - Part 2
Time Frame: Within 7 days after admission
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
Time Frame: Within 7 days after admission
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
Time Frame: Calculated through study completion after five months recruitment duration
Overall prevalence of malnutrition will be reported in percent
Calculated through study completion after five months recruitment duration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of sarcopenia - Risk for sarcopenia by SARC-F
Time Frame: Within 7 days after admission
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
Time Frame: Within 7 days after admission
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
Time Frame: Within 7 days after admission
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
Time Frame: Within 7 days after admission
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
Time Frame: Calculated through study completion after five months recruitment duration
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
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)
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
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)
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
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)
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
Time Frame: Within 7 days after admission
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
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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Undine Lehmann, Dr.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rehab Basel
Berner Reha Zentrum AG
Klinik Barmelweid
University Department of Geriatric Medicine FELIX PLATTER
Zürcher RehaZentrum Wald

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thimo Marcin, Dr., Berner Reha Zentrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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