Influence of the Body Composition of Neurological (Early) Rehabilitants on Rehabilitation Success

Overview

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.

Full Title of Study: “Investigation of the Influence of the Body Composition of Neurological (Early) Rehabilitants as Well as Their Change in the Course of Rehabilitation and the Effect on Rehabilitation Success – a Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 30, 2023

Detailed Description

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.

Interventions

  • Diagnostic Test: BIA
    • Bioelectrical Impedance Analysis

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Functional Status
    • Time Frame: 3 minutes
    • The Early Rehabilitation Barthel Index were determined upon admission and at the end of rehabilitation.
  • Disabilities
    • Time Frame: 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.
  • Muscle Strenght
    • Time Frame: 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.
  • Mobility
    • Time Frame: 4 minutes
    • The mobility is assed by the Rivermead Mobility Index.
  • Lenght Of Stay
    • Time Frame: < 1 minute
    • duration of neurological rehabilitation (in days)
  • Mortality
    • Time Frame: < 1 minute
    • Number of deaths
  • Discharge Level
    • Time Frame: < 1 minute
    • Status at discharge (discharged at home / long-term care facility, follow-up rehabilitation, death, transfer to acute hospital)

Secondary Measures

  • Bioelectrical Impedance
    • Time Frame: 15 minutes
    • Bioelectrical Impedances for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side.
  • Nutritional Risk Screening (NRS 2002)
    • Time Frame: 5 minutes
    • Malnutrition upon admission and at discharge is assed by the Nutritional Risk Screening (NRS 2002).
  • Mini Nutritional Assessment (MNA)
    • Time Frame: 5 minutes
    • Malnutrition upon admission and at discharge is assed by the Mini Nutritional Assessment (MNA).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • BDH-Klinik Hessisch Oldendorf
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jens D Rollnik, Prof. Dr., Study Director, BDH-Klinik Hessisch Oldendorf
  • Overall Contact(s)
    • Simone B Schmidt, Dr., 0049 (0)5152 781 215, si.schmidt@nkho.de

References

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.

Citations Reporting on Results

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.

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.

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