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Inverkan av kroppssammansättningen hos neurologiska (tidiga) rehabiliterande patienter på rehabiliteringsframgång

29 september 2026 uppdaterad av: BDH-Klinik Hessisch Oldendorf

Undersökning av påverkan av kroppssammansättningen hos neurologiska (tidiga) rehabiliteringspersoner samt deras förändring i rehabiliteringsförloppet och effekten på rehabiliteringsframgång - 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.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

57

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Cohort

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

Bioelectrical Impedance Analysis

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional Status
Tidsram: 3 minutes

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

3 minutes
Disabilities
Tidsram: 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
Tidsram: 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
Tidsram: 4 minutes

The mobility is assed by the Rivermead Mobility Index.

4 minutes
Lenght Of Stay
Tidsram: < 1 minute

duration of neurological rehabilitation (in days)

< 1 minute
Mortality
Tidsram: < 1 minute

Number of deaths

< 1 minute
Discharge Level
Tidsram: < 1 minute

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

< 1 minute

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Bioelectrical Impedance
Tidsram: 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)
Tidsram: 5 minutes

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

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

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

5 minutes

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Blood Pressure
Tidsram: 1 minute

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

1 minute
Pulse
Tidsram: < 1 minute

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

< 1 minute
Saturation
Tidsram: < 1 minute

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

< 1 minute
Body Height
Tidsram: 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
Tidsram: 5 minutes

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

5 minutes
Hip Circumference
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 november 2019

Primärt slutförande (Faktisk)

25 september 2023

Avslutad studie (Faktisk)

29 september 2026

Studieregistreringsdatum

Först inskickad

13 december 2019

Först inskickad som uppfyllde QC-kriterierna

16 december 2019

Första postat (Faktisk)

19 december 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • BIA-Studie

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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