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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04204655
Enrollment
57
Registered
2019-12-19
Start date
2019-11-25
Completion date
2026-07-31
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Rehabilitation

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.

Interventions

DIAGNOSTIC_TESTBIA

Bioelectrical Impedance Analysis

Sponsors

BDH-Klinik Hessisch Oldendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional Status3 minutesThe Early Rehabilitation Barthel Index were determined upon admission and at the end of rehabilitation.
Disabilities3 minutesAn 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 Strenght3 minutesThe hand force is measured with a hand force dyometer three times on each hand upon admission and at the end of rehabilitation.
Mobility4 minutesThe mobility is assed by the Rivermead Mobility Index.
Lenght Of Stay< 1 minuteduration of neurological rehabilitation (in days)
Mortality< 1 minuteNumber of deaths
Discharge Level< 1 minuteStatus at discharge (discharged at home / long-term care facility, follow-up rehabilitation, death, transfer to acute hospital)

Secondary

MeasureTime frameDescription
Bioelectrical Impedance15 minutesBioelectrical 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)5 minutesMalnutrition upon admission and at discharge is assed by the Nutritional Risk Screening (NRS 2002).
Mini Nutritional Assessment (MNA)5 minutesMalnutrition upon admission and at discharge is assed by the Mini Nutritional Assessment (MNA).

Countries

Germany

Contacts

STUDY_DIRECTORJens D Rollnik, Prof. Dr.

BDH-Klinik Hessisch Oldendorf

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026