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

Sponsor
BDH-Klinik Hessisch Oldendorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT04204655
Collaborator
(none)
45
1
41.2
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: BIA

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Nov 25, 2019
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Cohort

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

Diagnostic Test: BIA
Bioelectrical Impedance Analysis

Outcome Measures

Primary Outcome Measures

  1. Functional Status [3 minutes]

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

  2. Disabilities [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 [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 [4 minutes]

    The mobility is assed by the Rivermead Mobility Index.

  5. Lenght Of Stay [< 1 minute]

    duration of neurological rehabilitation (in days)

  6. Mortality [< 1 minute]

    Number of deaths

  7. Discharge Level [< 1 minute]

    Status at discharge (discharged at home / long-term care facility, follow-up rehabilitation, death, transfer to acute hospital)

Secondary Outcome Measures

  1. Bioelectrical Impedance [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) [5 minutes]

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

  3. Mini Nutritional Assessment (MNA) [5 minutes]

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

Other Outcome Measures

  1. Blood Pressure [1 minute]

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

  2. Pulse [< 1 minute]

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

  3. Saturation [< 1 minute]

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

  4. Body Height [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 [5 minutes]

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

  6. Hip Circumference [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 [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 [1 minute]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf Hessisch Oldendorf Lower Saxony Germany 31840

Sponsors and Collaborators

  • BDH-Klinik Hessisch Oldendorf

Investigators

  • Study Director: Jens D Rollnik, Prof. Dr., BDH-Klinik Hessisch Oldendorf

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
BDH-Klinik Hessisch Oldendorf
ClinicalTrials.gov Identifier:
NCT04204655
Other Study ID Numbers:
  • BIA-Studie
First Posted:
Dec 19, 2019
Last Update Posted:
Mar 2, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 2, 2022