- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04204655
Påvirkning av kroppssammensetningen til nevrologiske (tidlige) rehabiliteringspersoner på rehabiliteringssuksess
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
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Lower Saxony
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Hessisch Oldendorf, Lower Saxony, Tyskland, 31840
- Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
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
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
Sponsor
Etterforskere
- Studieleder: Jens D Rollnik, Prof. Dr., BDH-Klinik Hessisch Oldendorf
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Geyh S, Cieza A, Schouten J, Dickson H, Frommelt P, Omar Z, Kostanjsek N, Ring H, Stucki G. ICF Core Sets for stroke. J Rehabil Med. 2004 Jul;(44 Suppl):135-41. doi: 10.1080/16501960410016776.
- Stucki G, Cieza A, Geyh S, Battistella L, Lloyd J, Symmons D, Kostanjsek N, Schouten J. ICF Core Sets for rheumatoid arthritis. J Rehabil Med. 2004 Jul;(44 Suppl):87-93. doi: 10.1080/16501960410015470.
- Pirlich M, Schutz T, Norman K, Gastell S, Lubke HJ, Bischoff SC, Bolder U, Frieling T, Guldenzoph H, Hahn K, Jauch KW, Schindler K, Stein J, Volkert D, Weimann A, Werner H, Wolf C, Zurcher G, Bauer P, Lochs H. The German hospital malnutrition study. Clin Nutr. 2006 Aug;25(4):563-72. doi: 10.1016/j.clnu.2006.03.005. Epub 2006 May 15.
- Sorensen J, Kondrup J, Prokopowicz J, Schiesser M, Krahenbuhl L, Meier R, Liberda M; EuroOOPS study group. EuroOOPS: an international, multicentre study to implement nutritional risk screening and evaluate clinical outcome. Clin Nutr. 2008 Jun;27(3):340-9. doi: 10.1016/j.clnu.2008.03.012. Epub 2008 May 27.
- Elke G, Hartl WH, Kreymann KG, Adolph M, Felbinger TW, Graf T, de Heer G, Heller AR, Kampa U, Mayer K, Muhl E, Niemann B, Rumelin A, Steiner S, Stoppe C, Weimann A, Bischoff SC. [DGEM Guideline "Clinical Nutrition in Critical Care Medicine" - short version]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2019 Jan;54(1):63-73. doi: 10.1055/a-0805-4118. Epub 2019 Jan 8. German.
- Schmidt SB, Boltzmann M, Rollnik JD. Nutritional situation of enterally fed patients in neurological early rehabilitation and impact of nutritional status on functional outcome. Clin Nutr. 2020 Feb;39(2):425-432. doi: 10.1016/j.clnu.2019.02.011. Epub 2019 Feb 10.
- Schmidt SB, Boltzmann M, Krauss JK, Stangel M, Gutenbrunner C, Rollnik JD. Standardized nutritional supply versus individual nutritional assessment: Impact on weight changes, complications and functional outcome from neurological early rehabilitation. Clin Nutr. 2020 Apr;39(4):1225-1233. doi: 10.1016/j.clnu.2019.05.013. Epub 2019 May 16.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
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