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Påvirkning av kroppssammensetningen til nevrologiske (tidlige) rehabiliteringspersoner på rehabiliteringssuksess

29. september 2026 oppdatert av: BDH-Klinik Hessisch Oldendorf

Undersøkelse av innflytelsen av kroppssammensetningen til nevrologiske (tidlige) rehabiliteringspersoner så vel som deres endring i rehabiliteringsforløpet og effekten på rehabiliteringssuksess - en pilotstudie

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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

57

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Cohort

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

Bioelectrical Impedance Analysis

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. november 2019

Primær fullføring (Faktiske)

25. september 2023

Studiet fullført (Faktiske)

29. september 2026

Datoer for studieregistrering

Først innsendt

13. desember 2019

Først innsendt som oppfylte QC-kriteriene

16. desember 2019

Først lagt ut (Faktiske)

19. desember 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • BIA-Studie

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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