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Indflydelse af kropssammensætningen af ​​neurologiske (tidlige) rehabiliteringspersoner på rehabiliteringssucces

29. september 2026 opdateret af: BDH-Klinik Hessisch Oldendorf

Undersøgelse af indflydelsen af ​​neurologiske (tidlige) rehabiliteringspersoners kropssammensætning samt deres ændring i rehabiliteringsforløbet og effekten på rehabiliteringssucces - en pilotundersøgelse

An optimal nutritional supply is associated with better outcome and recovery. For investigating the influence of the nutritional status and body composition on the course of rehabilitation, bioelectrical impedance analyzes (BIA) should be carried out on neurological (early) rehabilitants during the rehabilitation process.

Possible disturbances, suitable outcome valuesfor evaluation of the rehabilitation success (depending on the rehabilitation phase) as well as the required frequency of the BIA measurements in rehabilitation should be estimated with the help of this pilot study.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

An optimal coverage of the required calorie requirement is a basic prerequisite for a speedy recovery. One study reports that almost every fourth patient is malnourished in German hospitals. Malnutrition is in turn associated with more complications, higher mortality and longer length of stay. The current DGEM (Deutsche Gesellschaft für Ernährungsmedizin) guideline "Clinical nutrition in intensive care" recommends a calorie intake of 24 kcal per kg body weight during the acute phase of the disease (days 1 to 7) and an increase of calorie intake to 36 kcal per kg body weight in the convalescence and rehabilitation phase.

In a recent study evaluating the weight profile of neurological, enteric-coated early rehabilitants in rehabilitation, 60.6% of patients had weight loss during rehabilitation. Men were also more likely to lose weight than women. In addition, the caloric care of "underweight patients" had a decisive influence on the neurological outcome (as measured by the early rehab barthel-index(FRBI)). For example, underweight patients who were under-served showed significantly lower improvements in FRBI than underweight patients who were over-served.

In another study, the weight of patients remained stable through the use of a nutritional assessment tool (EAT). Also the gender difference was not confirmed in the group with the EAT. The weight change in the rehabilitation course correlated significantly with the difference between the calculated and the average calories received per day. However, an effect of EAT on the frequency of complications or the neurological outcome could not be demonstrated in this study.

However, as body weight may be affected by water balance (edema) and gastrointestinal complications such as constipation, vomiting and diarrhea, consideration of body weight to check diet / nutrition status alone is insufficient. Qualitative statements such as an increase / decrease in muscle mass can not be made on the basis of the weight data. Therefore, in the planned pilot study body composition will be documented by means of bioelectric impedance analysis (BIA) in neurological (early) rehabilitants during rehabilitation. At the same time, various outcome parameters are to be recorded.

The aim of this pilot study is to identify the number and frequency of BIA measurements required to assess the status of care. On the basis of this data, a study is then to be designed to investigate the success of rehabilitation as a function of nutritional status and muscle mass.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

57

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Lower Saxony
      • Hessisch Oldendorf, Lower Saxony, Tyskland, 31840
        • Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Included in each case are 15 neurological and neurosurgical (early) rehabilitants of phase B, C and D (45 patients in total) of both sexes aged ≥ 18 years.

Beskrivelse

Inclusion Criteria:

  • neurological disease

Exclusion Criteria:

  • electrical implant as cardiac pacemaker, medications pumps, defibrillators
  • pregnancy or breastfeeding period
  • take part on another study within the last 30 days
  • spasticity
  • amputation of limbs

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Cohort

rehabilitants of the phase B, C and D during neurological rehabilitation

Bioelectrical Impedance Analysis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional Status
Tidsramme: 3 minutes

The Early Rehabilitation Barthel Index were determined upon admission and at the end of rehabilitation.

3 minutes
Disabilities
Tidsramme: 3 minutes

An ICF-Assessment of 20 items is used for determination of disabilities of activities and body functions. The severity of each item is scored from zero ("no impairment") to four ("complete impairment") upon admission and at the end of rehabilitation.

3 minutes
Muscle Strenght
Tidsramme: 3 minutes

The hand force is measured with a hand force dyometer three times on each hand upon admission and at the end of rehabilitation.

3 minutes
Mobility
Tidsramme: 4 minutes

The mobility is assed by the Rivermead Mobility Index.

4 minutes
Lenght Of Stay
Tidsramme: < 1 minute

duration of neurological rehabilitation (in days)

< 1 minute
Mortality
Tidsramme: < 1 minute

Number of deaths

< 1 minute
Discharge Level
Tidsramme: < 1 minute

Status at discharge (discharged at home / long-term care facility, follow-up rehabilitation, death, transfer to acute hospital)

< 1 minute

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bioelectrical Impedance
Tidsramme: 15 minutes

Bioelectrical Impedances for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.

15 minutes
Nutritional Risk Screening (NRS 2002)
Tidsramme: 5 minutes

Malnutrition upon admission and at discharge is assed by the Nutritional Risk Screening (NRS 2002).

5 minutes
Mini Nutritional Assessment (MNA)
Tidsramme: 5 minutes

Malnutrition upon admission and at discharge is assed by the Mini Nutritional Assessment (MNA).

5 minutes

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood Pressure
Tidsramme: 1 minute

Blood pressure (mmHg) is measured before each BIA measurement.

1 minute
Pulse
Tidsramme: < 1 minute

Pulse (bmp) is measured with a finger pulse oxymeter before each BIA measurement.

< 1 minute
Saturation
Tidsramme: < 1 minute

Saturation (%) is measured with a finger pulse oxymeter before each BIA measurement.

< 1 minute
Body Height
Tidsramme: 2 minutes

Height is measured in a standing position with a measuring tape. In the case that the patient is not able to stand, the measurement is performed in a lying position.

2 minutes
Body weight
Tidsramme: 5 minutes

Weight (kg) is measured in the morning with clothes but without shoes.

5 minutes
Hip Circumference
Tidsramme: 1 minute

Hip circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand).

1 minute
Waist Circumference
Tidsramme: 1 minute

Waist circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand).

1 minute
Calf Circumference
Tidsramme: 1 minute

Calf circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand).

1 minute

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Jens D Rollnik, Prof. Dr., BDH-Klinik Hessisch Oldendorf

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. november 2019

Primær færdiggørelse (Faktiske)

25. september 2023

Studieafslutning (Faktiske)

29. september 2026

Datoer for studieregistrering

Først indsendt

13. december 2019

Først indsendt, der opfyldte QC-kriterier

16. december 2019

Først opslået (Faktiske)

19. december 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • BIA-Studie

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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