- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04204655
Vliv tělesného složení neurologické (časné) rehabilitace na úspěch rehabilitace
Zkoumání vlivu tělesného složení neurologických (časných) rehabilitací a jejich změny v průběhu rehabilitace a vlivu na rehabilitační úspěšnost - pilotní studie
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Lower Saxony
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Hessisch Oldendorf, Lower Saxony, Německo, 31840
- Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Cohort
rehabilitants of the phase B, C and D during neurological rehabilitation |
Bioelectrical Impedance Analysis |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Functional Status
Časové okno: 3 minutes
|
The Early Rehabilitation Barthel Index were determined upon admission and at the end of rehabilitation. |
3 minutes
|
|
Disabilities
Časové okno: 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
Časové okno: 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
Časové okno: 4 minutes
|
The mobility is assed by the Rivermead Mobility Index. |
4 minutes
|
|
Lenght Of Stay
Časové okno: < 1 minute
|
duration of neurological rehabilitation (in days) |
< 1 minute
|
|
Mortality
Časové okno: < 1 minute
|
Number of deaths |
< 1 minute
|
|
Discharge Level
Časové okno: < 1 minute
|
Status at discharge (discharged at home / long-term care facility, follow-up rehabilitation, death, transfer to acute hospital) |
< 1 minute
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Bioelectrical Impedance
Časové okno: 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)
Časové okno: 5 minutes
|
Malnutrition upon admission and at discharge is assed by the Nutritional Risk Screening (NRS 2002). |
5 minutes
|
|
Mini Nutritional Assessment (MNA)
Časové okno: 5 minutes
|
Malnutrition upon admission and at discharge is assed by the Mini Nutritional Assessment (MNA). |
5 minutes
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Blood Pressure
Časové okno: 1 minute
|
Blood pressure (mmHg) is measured before each BIA measurement. |
1 minute
|
|
Pulse
Časové okno: < 1 minute
|
Pulse (bmp) is measured with a finger pulse oxymeter before each BIA measurement. |
< 1 minute
|
|
Saturation
Časové okno: < 1 minute
|
Saturation (%) is measured with a finger pulse oxymeter before each BIA measurement. |
< 1 minute
|
|
Body Height
Časové okno: 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
Časové okno: 5 minutes
|
Weight (kg) is measured in the morning with clothes but without shoes. |
5 minutes
|
|
Hip Circumference
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Jens D Rollnik, Prof. Dr., BDH-Klinik Hessisch Oldendorf
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- BIA-Studie
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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