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

Active, not recruiting

• Conditions: Neurological Rehabilitation
• Interventions: Diagnostic Test: BIA

• Registration Number: NCT04204655
• Lead Sponsor: BDH-Klinik Hessisch Oldendorf

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.

Study Timeline

• Study Start: 2019-11-25
• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-19
• Primary Completion: 2023-09-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	BIA	rehabilitants of the phase B, C and D during neurological rehabilitation

Primary Outcome Measures

Name	Time	Method
Mobility	4 minutes	The mobility is assed by the Rivermead Mobility Index.
Lenght Of Stay	< 1 minute	duration of neurological rehabilitation (in days)
Functional Status	3 minutes	The Early Rehabilitation Barthel Index were determined upon admission and at the end of rehabilitation.
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.
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.
Mortality	< 1 minute	Number of deaths
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

Name	Time	Method
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.
Nutritional Risk Screening (NRS 2002)	5 minutes	Malnutrition upon admission and at discharge is assed by the Nutritional Risk Screening (NRS 2002).
Mini Nutritional Assessment (MNA)	5 minutes	Malnutrition upon admission and at discharge is assed by the Mini Nutritional Assessment (MNA).

Trial Locations

Locations (1)

Institute for Neurorehabilitation Research, BDH-Clinic Hessich Oldendorf; 🇩🇪 Hessisch Oldendorf, Lower Saxony, Germany