Clinical trial NCT04204655: Influence of the Body Composition of Neurological (early) Rehabilitants on Rehabilitation Success
Official title: 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: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neurological Rehabilitation
Lead sponsor: BDH-Klinik Hessisch Oldendorf
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Status
timeFrame: 3 minutes
measure: Disabilities
timeFrame: 3 minutes
measure: Muscle Strenght
timeFrame: 3 minutes
measure: Mobility
timeFrame: 4 minutes
measure: Lenght Of Stay
timeFrame: < 1 minute
measure: Mortality
timeFrame: < 1 minute
measure: Discharge Level
timeFrame: < 1 minute
Secondary outcomes:
measure: Bioelectrical Impedance
timeFrame: 15 minutes
measure: Nutritional Risk Screening (NRS 2002)
timeFrame: 5 minutes
measure: Mini Nutritional Assessment (MNA)
timeFrame: 5 minutes
Other outcomes:
measure: Blood Pressure
timeFrame: 1 minute
measure: Pulse
timeFrame: < 1 minute
measure: Saturation
timeFrame: < 1 minute
measure: Body Height
timeFrame: 2 minutes
measure: Body weight
timeFrame: 5 minutes
measure: Hip Circumference
timeFrame: 1 minute
measure: Waist Circumference
timeFrame: 1 minute
measure: Calf Circumference
timeFrame: 1 minute
Locations:
city: Hessisch Oldendorf
country: Germany
facility: Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf
state: Lower Saxony
Study officials:
affiliation: BDH-Klinik Hessisch Oldendorf
name: Jens D Rollnik, Prof. Dr.
role: STUDY_DIRECTOR
References:
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citation: 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.
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