Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04204655

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf

Hessisch Oldendorf, Lower Saxony, 31840, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIA

Diagnostic Test

Bioelectrical Impedance Analysis

Primary outcomes

  1. Functional Status

    Time frame: 3 minutes

    The Early Rehabilitation Barthel Index were determined upon admission and at the end of rehabilitation.

  2. 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.

  3. 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.

  4. Mobility

    Time frame: 4 minutes

    The mobility is assed by the Rivermead Mobility Index.

  5. Lenght Of Stay

    Time frame: < 1 minute

    duration of neurological rehabilitation (in days)

  6. Mortality

    Time frame: < 1 minute

    Number of deaths

  7. 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 outcomes

  1. 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.

  2. Nutritional Risk Screening (NRS 2002)

    Time frame: 5 minutes

    Malnutrition upon admission and at discharge is assed by the Nutritional Risk Screening (NRS 2002).

  3. Mini Nutritional Assessment (MNA)

    Time frame: 5 minutes

    Malnutrition upon admission and at discharge is assed by the Mini Nutritional Assessment (MNA).

Other outcomes

  1. Blood Pressure

    Time frame: 1 minute

    Blood pressure (mmHg) is measured before each BIA measurement.

  2. Pulse

    Time frame: < 1 minute

    Pulse (bmp) is measured with a finger pulse oxymeter before each BIA measurement.

  3. Saturation

    Time frame: < 1 minute

    Saturation (%) is measured with a finger pulse oxymeter before each BIA measurement.

  4. Body Height

    Time frame: 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.

  5. Body weight

    Time frame: 5 minutes

    Weight (kg) is measured in the morning with clothes but without shoes.

  6. Hip Circumference

    Time frame: 1 minute

    Hip circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand).

  7. Waist Circumference

    Time frame: 1 minute

    Waist circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand).

  8. Calf Circumference

    Time frame: 1 minute

    Calf circumference is measured with a measuring tape in a standing position (or lying position if the patient can not stand).

Sponsors and collaborators

Lead sponsor

BDH-Klinik Hessisch Oldendorf

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Dec 19, 2019
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.