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Completed

NCT Number: NCT05639985

The Prevalence of Malnutrition and Sarcopenia in Swiss Rehabilitation Settings

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik Barmelweid AG, Barmelweid, Switzerland

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Body weight

    Time frame: Within 7 days after admission

    (in kg)

  3. Height

    Time frame: Within 7 days after admission

    (in cm)

  4. Body Mass Index

    Time frame: Within 7 days after admission

    (calculated by weight and height in kg/m2)

  5. 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)

  6. 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)

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

    Time frame: Within 7 days after admission

    Resistance (in Ohm) and Reactance (in Ohm)

  8. 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)

  9. 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)

  10. Prevalence of malnutrition - overall

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

    Overall prevalence of malnutrition will be reported in percent

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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).

  5. 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).

  6. Prevalence of sarcopenia - Overall

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

    Overall prevalence of sarcopenia will be reported in percent

  7. 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)

  8. 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)

  9. 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)

  10. 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.

Sponsors and collaborators

Lead sponsor

Undine Lehmann, Dr.

Other

Collaborators

  • Berner Reha Zentrum AG
  • Klinik Barmelweid
  • Rehab Basel
  • University Department of Geriatric Medicine FELIX PLATTER
  • Zürcher RehaZentrum Wald

Registry information

Acronym: Malnut-Reha

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2022
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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